Charlotte Chadwick — Clinology: Making Consultants More Visible in Pharma

Speaker:I am Adam Walker, a biometrics consultant, and this is the Pharma Prescribed Podcast where leaders, innovators, and hidden voices in healthcare open up, no soundbites, no spin, just raw insight, one prescription at a time in an industry driven by data protocols and pressure. To ask the human questions, what drives us, what breaks us, and what truths live behind the titles.

Speaker:Our guest today is Charlotte Chadwick, founder of Clinology, a consultancy helping pharma rethink trials through the lens of operational depth and human centered design. Charlotte brings over 25 years of experience in clinical research spanning senior roles across CROs, sponsors, and consultancies.

Speaker:She\'s led early phase delivery at MAC Clinical Research driven neuroscience trial strategy at Lundbeck, and served as Chief operating Officer at Zigzag Associates, a global quality assurance consultancy supporting pharma, biotech and MedTech clients. Now with Clinology and as an independent consultant, Charlotte is bringing that full spectrum experience to bear.

Speaker:Offering pharma partners who understand the science, the systems, and the true requirements behind every protocol. Charlotte, welcome to Pharma Prescribed.

Speaker 2: Thanks so much, Adam. I\'m really pleased to be here.

Speaker:It\'s such a pleasure to see you again and reconnect.

Speaker:I\'d love to just hear as our audience would a little bit of your backstory, how you got into clinical research in the first place.

Speaker 2: Yeah, absolutely. , It was one of those interesting things when I was at university, I knew I was a total disaster in the lab. I was doing a science degree. I knew if I touched anything that was any way practical, it would go horribly wrong. But I knew that I had a really good head for administration and organization and I was really interested in medical research and going into acareer that would help people.

Speaker 2: And I came across a book, and it was a book that was in the old days, , called, so You Want to be a CRA? , And I read the book from page to page and thought, this sounds really interesting. This sounds a really good way I can get involved in medical research and medical trials. But it seems tospeak to my admin and my organizational side of things.

Speaker 2: So I went about trying to find companies in clinical research where I could start off, \'cause we all know it\'s very, very hard to. Started off as a CRA and I was really, really fortunate that I landed with a company in Manchester that was around at that time called Shain Clinic. They had a cork, , clinical trial site doing phase one generic studies, and they opened their Manchester site and I joined there as a junior qc.

Speaker 2: And within two years of being there, I actually became their site manager. , Learned everything I needed to know about phase one trials and the generic situation. Made some great friends and great colleagues there. And I moved from there into Lubeck, where I started off as a CRA, and finally got my chance to put everything I\'d read in this booklet into action.

Speaker 2: And I became an early phase CRA phase one specialist. So that was really interesting.

Speaker 2: And then I worked my way up the ranks in Becks through CRA, and then I went into operations and realized that was really where my true. Passion, like with Lundbeck, , I actually had the responsibility for traveling all over the world, finding the phase one units that they wanted to use for their, , for their studies, assessing them, doing the due diligence on them, and creating all the processes around it.

Speaker 2: So I had an incredible 13 year career with Lundbeck and. I reckon in that time I saw 80 to 90% of the phase one units in the world and read all their processes, and I kept going to places in Hong Kong and in America and thinking that\'s a really cool way to do a phase one study. That\'s a really cool process to have and thought, I want to take all this knowledge that I\'ve got.

Speaker 2: I. Run the best phase one unit I can, but create a gold flag phase one unit. So Iapproached Icon, , who were looking for a director of their phase one unit in Manchester at the time, and I joined them in 2013. Unfortunately, due to some, , strategic and business situations within icon, the unit quite rapidly closed down.

Speaker 2: , So I was actually involved in that process of closing the unit down at Icon, and moving on, , with Icon into project manager. Management.

Speaker 2: But then I had the opportunity that Mac clinical research came along and they had the opportunity to utilize icon\'s, new building that they had in Manchester and build a phase one unit from scratch.

Speaker 2: And that\'s what I\'d really, really been passionate about doing. So I went and joined Mac and had a fantastic six years there. We built the phase one unit. I determined it an early phase unit. It got termed The EPU wish to this day I\'d trademarked that \'cause it\'s now used all over the place. But we termed it in early phase unit \'cause we really turned it out of first in human trials andreally healthy volunteer studies into patients, which is where everything was going into more patients studies.

Speaker 2: In fact, the very first study we run there to get our accreditation, we use patients. Not just healthy volunteers. So it was a real innovation and a real chance to learn from the ground up. , We built that unit with our bare hands, we put all the processes in place, we brought all the team on board, and then we grew it over the time that I was there.

Speaker 2: We went through some incredible times. We got accreditation three times with no major findings. We grew the SMO network withinMac, and I was real proud to be part of that as our vice President of clinical operations, helping with the late face sites, learning about the SMO side of the world.

Speaker 2: And then I got to the point with Mac and through COVID, where I felt had taken the phase one unit as far as I could do.

Speaker 2: And I wanted to really learn about C-Suite and going into different operational roles. So that\'s when I joined Zigzag, who were the, , QA consultancy. We were doing QA audits all across the world. Had an amazing three years growing with them, learning about C-suite and strategic , opportunities, really helping increase the QA auditing across the world, working with consultants, , and full-time employees, and a really great team of people.

Speaker 2: And then I went from there and. Took a bit of stock in my life and took a bit of decision about where I wanted to be in my life and what I wanted to do. I really enjoyed doing my operations side of things. , I really wanted to do a lot of different projects, , and a lot of different, environments,

Speaker 2: people kept saying to me, have you ever thought of running your own business? And I went, , no. I can\'t run my own business. That\'s not possible. I couldn\'t do that. And then I look at myself 12 months later and I now have two businesses. So I have the full-time consultancy, which is Dynamic Clinical Solutions, which is just me.

Speaker 2: I. Acting as a full-time consultant and I work in clinical operations, , and do a variety of different projects, which is a fantastic thing \'cause every single day there\'s something new and something different. I work with, , clinical CROs who are just setting up and getting started and building their processes.

Speaker 2: I work with clinical sites and, , SMOs helping them either achieve accreditation or working towards expansion and efficiency and looking at their gap analysis. I\'m working on a fractional basis as a clinical operations strategic advisor with Wise Health, who are an AI enabled platform in real world evidence and also working in a study throughput pro, products where we help, , feasibility and site recruitment.

Speaker 2: And I get to also work with, up and coming medical device companies who are trying to get. , Into clinical trials on the markets as their clinical advisor. And I work with, private investors, and venture capitalists when they\'re looking to do purchases, helping them with due diligence, helping them assess the quality of their purchases.

Speaker 2: So, like I said, every single day is different.

Speaker:That\'s amazing. You\'ve done a lot Charlotte. And firstly, I.

Speaker:Our time together when we worked together was of course at at Mac Clinical in Manchester. And all of that experience that you called upon in your background. Now you\'re applying to Clinology. Yes. Can you tell us a little bit more about that please?

Speaker 2: Yeah, so Clinology came about because when I set up as a consultant, I think it was in September, October last year, I started looking at where can I advertise myself as a consultant?

Speaker 2: I looked at LinkedIn, I. Then so that your posts just get buried on LinkedIn. I looked at going out to the recruiters, and the recruiters are a fantastic, amazing bunch of people and they\'re really out there to help, but they do take commission and they do put prices onto consultants, which sometimes rules out the startups, the biotechs, and the early people who need that expertise.

Speaker 2: Then I looked at other kind of methods, which was finding it through my own network, and I sat there and thought with my operational head on, why is this so hard? Why is there not something simple out there? Now, I know there\'s consortiums out there and fantastic consortiums out there that people can join that put you out as a consultant and they\'ll create a contract with the client.

Speaker 2: But I just thought, I want this to be really easy. I want to be able to give something of value to people and consultants, to give them a platform to advertise themselves where we can. Act as a consortium, act as a collaboration. We can pool our money together to market ourselves as a full company, and that\'s where the benefit of Clinology comes from.

Speaker 2: So the idea is that consultants put their profiles on the platform. They pay a subscription that I like to save the price of a few fancy coffees a week if you are working in an office. And that gives them full company level marketing, which we put behind it, behind Clinology. And from the client perspective, someone wants to come on and find a consultant.

Speaker 2: We don\'t charge. Any contract costs or anything like that, we literally charge them a credit to unlock details. And once they\'ve unlocked the details, they\'re completely in touch with that consultant and we step out. We\'re not middlemen, we don\'t try and get involved in contracts, we don\'t get involved in any of the work after that.

Speaker 2: I\'m trying to make it very, very simple like Fiverr or People per Hour. That\'s the kind of thing I\'m basing it on with everyone in clinical research and any consultant. So. For example, data management, people like yourself, biostatisticianspeople in medical writing, medics, we\'ve got on their quality assurance.

Speaker 2: Any type of consultants and clinical research that wants to make themselves more visible. And that\'s the key. I want to make people more visible and I want to help people find the work, and I want to help the startups and the Pharma\'s and the biotechs that have small projects that may have been priced out of the market, find that expertise they need to really get started and get that timeline advancing.

Speaker:It\'s a brilliant business model, and I think it\'s clear to me as an independent consultant how difficult it\'s to find that work. To put yourself out there to be visible, but also to identify where those opportunities are, can often be just right place, right time, right conversation, or a passing conversation that you happen upon a, at a conference or something like that.

Speaker:Or a former colleague or someone within your professional network might mention you in passing to someone else. I\'m interested to know what the uptake has been like and what you\'ve been doing with the energy around Clinology recently.

Speaker 2: Yeah, absolutely. So we\'ve actually only been live for five weeks.

Speaker 2: It seems like a very long five weeks. It\'s really exciting. But we\'ve been up on live for five weeks since the end of May. We\'ve already got around 20 consultants signed up onto the platform. We have at least another 30 consultants. In the signup process that I haven\'t actually gone live yet and we have around 10 clients signed up onto the platform.

Speaker 2: In the time that we\'ve been doing things, I\'ve tried different marketing because I\'m very aware it\'s my responsibility to market this company and to use the subscription costs in the best way that I can. So there\'s a few different things I do. One, and I say this really lackadaisically, but I like to, I like people to understand I don\'t run chron Clinology as a full-time business.

Speaker 2: I don\'t take any salary from Clinology, the whole of the revenue. From Clinology goes back into the platform because my full-time role is as a consultant. That\'s how I make my money. I\'m doing this because I wanted to make myself more visible as a consultant, and I wanna help people along with it. So I then sit and think, because Clinology\'s only me and I\'ve.

Speaker 2: Learned a lot and I\'m learning a lot about marketing. I do have a best friend in chat, GPT that helps me along the way a little bit. But I\'m also looking at other things. So in June we went to a conference. We went to OCT UK in London, and I was really proud that I got to take my son with me, who became my events and conference assistant and was fantastic on the stalltalking to everybody and wewe were talking to people, engaging in people, and getting really, really good feedback.

Speaker 2: The people like, this is a really great idea. We think this could be really good for the future, and that was really, really great to hear. Also, I\'m doing a panel tomorrow at Healthtech Integrates in Manchester, which is at the bright building in Manchester, to promote Clinology as well. We do marketing posts on LinkedIn.

Speaker:i\'ve been needing for a while. , There, there are certain efforts. As a consultant, you have to direct yourself towards and knowing that something is happening behind the scenes, that\'s just putting you out there outside of your actual day-to-day effort is really powerful. So that\'s really wonderful and thank you for doing that.

Speaker:And I\'m sure our audience will be fascinated to hear more about Clinology as it develops. What other things are you involved in at the moment and what gets you outta bed in the morning?

Speaker 2: Like I said, it is, I love being able to do so many different things. I love being able to do so many different projects and different hats, so I get to jump from advising people around s SOPs to doing commercialization and business development and helping promote this.

Speaker 2: The AI platform I work with for is because I really feel that\'s got real grounding in the industry, and then I get to talk to people who are, have gotten new technology and they\'re getting grants and investments. To go out onto then do their clinical research and get, get these really, interesting devices out onto the market.

Speaker 2: And then I get to help with, preclinical CROs that are trying to turn into clinical CROs. I\'m really invested in the industry. I\'ve worked for a pharmaceutical company. I\'ve worked for A CRO, I\'ve worked for an SMO. I spent a lot of time at the moment within the market around CROs and SMOs, and I\'m seeing a shift in the market.

Speaker 2: Especially from the away from the traditional, CRO method. Now, I think there\'s a real great place for the traditional CROs in the world, but there\'s also a place for a much more agile, nimble system with the smaller companies, the startups, the biotechs, the smallest pharmaceutical companies.

Speaker 2: Starting to find that advancing onto the market is becoming much easier with the advent of AI helping them in the background. So there\'s a lot more people out there with a lot more innovative drugs that want to come onto the market and they want to get their drug to a point where they can get efficacy data, they can get safety data, and they can then go and talk to one of the big pharmaceutical companies about potential purchase.

Speaker 2: And that\'s a space I really find interesting and I really enjoy working in. And I really find that consultants can help with that. And that\'s where Clinology can really come in because it\'s where these companies need to be nimble, agile. They need to have not a lot of overheads, they can\'t take on full-time employees, but they need the absolute right expertise at the right time.

Speaker 2: So that\'s what we intend to do with Clinology is get them, those experts really quickly match them with very little cost to them so that they can get them on board. And start this whole process moving. So everybody gets to have a fun day like me, where you wake up in the morning, you don\'t know if you\'re gonna be talking to Puerto Rico, you don\'t know if you\'re gonna be talking to Saudi.

Speaker 2: You don\'t know if you\'re going to be working on a medical device that goes in someone\'s ear or working on large language models. A really great thing to be able to do with our expertise.

Speaker:You made a couple of points there around AI and one of the companies that you working with at.

Speaker:It\'s something that everyone is talking about. We\'re all using it in the palm of our hand and we\'ve, in the last probably six to 12 months, become quite blase about the use of ai. How do you see that being developed into clinical research, into drug trials in the development process? Do you have concerns around that opportunity for guardrails and just the human in the loop piece?

Speaker 2: I think the real key in it is that AI is there as a tool. It\'s a tool to support us. It is not the final entity. It\'s not the be all and end all. There has to be regulation around it, and there has to be guardrails around it. It has to be taken as. Advice, it has to be taken as something that\'s supportive, but it\'s got to be looked at closely.

Speaker 2: And I think what we need is the regulations to come around it. And I know that\'s starting to happen. \'Cause I know from my links in quality and my links in qa. But we do need this regulation around it and the regulatory agencies to really focus on what they want and what they want to see so that people can truly understand what they\'re doing around it.

Speaker:Yes, absolutely. I agree with that.

Speaker:And for many of the listeners that might be following Pharma prescribed, I know they\'re at the beginning of their journey into clinical research. You are an esteemed and highly qualified per person of huge experience in and around clinical research learned through doing.

Speaker:What advice would you give to people just starting out in the industry now, because it\'s a really tough place to get into, isn\'t it? But with all of these tools out there. How do you know what\'s good, what\'s bad, what it feels like and what it looks like.

Speaker 2: Exactly. And it is, it is a struggle of an industry to get into.

Speaker 2: It has always, it has always been a struggle of the industry to get into, like I said, when I started off as a CRA. It was the age old, you couldn\'t get a role as a CRA if you didn\'t have experience. And it was very, very hard to get experience. And Adam, you and I know from runningthe clinical units and the clinical sites, the clinical sites are the breeding ground for experience in clinical research.

Speaker 2: And although that\'s a great, it\'s a fantastic environment and I encourage anybody out there wanting to get into clinical research, look locally, see if there\'s a clinical site, see if you can get internships there, see if you can do work. Experience there. See if you can get some of the foundation level jobs.

Speaker 2: \'cause there\'s nothing that prepares you for clinical research, like working on the floor of a clinical site. However, what we also know is that has the knock on impact in our industry, in our world, in that clinical sites have a huge turnover of staff because you train your staff up, they learn about clinical research, and then you send them off into more experienced roles.

Speaker 2: The bigger companies that can pay them the most money. So we have to have a bit of thought about the clinical sites and how they really are this breeding ground for training and they really are turning over this staff and putting them into the more experienced roles. But in starting out today, I mean it really speaks to me.

Speaker 2: \'cause I know, and I know I saw your post earlier on LinkedIn, you act as a mentor as well at Greenwich, and I\'m acting as a mentor at. ICRand Helping third year students that want to go into clinical research, helping \'em with interview techniques where they could potentially do internships, where they could look at getting experience.

Speaker 2: And also helping them with, we said, what technology there is out there on the market, how to use things. Because I think with the advent of things like chat, GPT. Understanding how to use it and understanding where it can support you and it can help you, but that you actually also need to do the work yourself as well.

Speaker 2: So where it can give you a launching pattern and give you ideas and things that you can think about and take further, but it can do that ground research for you.

Speaker:Yeah, I completely agree with that. Only last week, funnily enough, I was talking to, a master\'s student at the University of Greenwich who reached out to me and was contacting me about how to get into the industry and exactly to the point that you were making.

Speaker:I suggested an early phase clinical trial is the best place to get that exposure. It was certainly where I, I learned so much in my, in my early days of Richmond Pharmacology. Subsequently at. I think for anyone coming into this industry, you just have the exposure. You can see things, you can feel it.

Speaker:You\'re at the bedside, you\'re seeing those ECGs being taken in triplicate. You\'re seeing the devices alongside, , the beds, and there are so many roles and opportunities to grow as an individual, really from the ground up. The translation of protocol into action I think is really what I took away from that experience so much.

Speaker:I\'m still connected with one of my former bosses from the early days at Richmond Pharmacology, and we work together still. People remember the way that you work together, but also, you know the way you make them feel, and hopefully they remember the good.

Speaker:Trials is something that I would encourage all of our listeners if they haven\'t been exposed to. What urgency is until you\'ve been in that environment, do you?

Speaker 2: Precisely, precisely.

Speaker 2: There is nothing like writing a protocol and putting your, all your procedures in it and then actually going, watching it happen on the floor, on the ward when you\'re like, we\'ve got a one single time point and we need to.

Speaker 2: Take an E, CG. We need to take vital signs. We need to do a brain scan, we need to take a blood sample and trying to fit all that. And it really makes you start thinking about protocols. And I think it\'s really interesting in this day and age, because protocols are becoming much more complex. We\'re trying to put much more innovation into protocols and are a real proponent of putting innovation into.

Speaker 2: Protocols, but sometimes we are putting too much into protocols and we\'re massively over complicating and we are taking too much information. I was having this interesting talk with one of my colleagues from wise when we were out at, HLTH the other week in Amsterdam, and it was a big health tech conference.

Speaker 2: So much health technology out there, and we were talking about the continuous monitoring that everybody\'s doing now. So, for example, my husband has a bracelet on where I can monitor his blood pressure 24 hours a day, and I get. I get reading probably every five minutes from him. There were beds out there that for, for ICUs that you can monitor everything.

Speaker 2: And we said, is there a point where you get too much data? Is there a point where you\'re getting so much data you can\'t actually react to it? Because how do you know what to react to? Because I remember when we used to be in the early phase units and we had people attached to the telemetry, and it was beeping every two minutes.

Speaker 2: You know, someone\'s heart rate went slightly off and we used to have doctors there continually watching it, reading it, and then deciding what they reacted to. And this is where we come back to that interesting conversation between AI and actual humans and people. Can ai, AI can flag all these different things to you, but it takes a human to actually think, is that something that has to be reacted to?

Speaker 2: I apologize. We have a special guest that\'s just a,

Speaker:my special guest is just outside at the moment. What\'s the name of you? Lovely cat.

Speaker 2: This one\'s Gizmo. He thinks I\'m a bond villain, and every time I\'m on a video call, he insists on coming and sitting on my knee. So it\'s my sidelinemymy extra job as a consultant.

Speaker 2: I\'mI\'m A bond villain as well.

Speaker:Well, this is the beauty of being a consultant. You can work from home. You can certainly be around your animals, your children, whoever else. Certainly be my experience. I\'ve got three beds. And

Speaker 2: I was gonna say, Adam, I think this will, you\'ll understand this as much as I did. I\'ve come from a very corporate world.

Speaker 2: I\'veI\'m Very passionate about my work. I get very involved in my work and I\'ve spent many years giving my whole life into my work and being attached to the emailGetting to the point where I was working from six o\'clock in the morning until 11 o\'clock at night, I wasI wouldand I would be constantly attached to my emails.

Speaker 2: And I think in the last 12 to 18 months, there\'s been a real shift in my life. That\'s happened where I\'ve actually had to think, I need to think about something different. And it\'sand that\'s what consultancy has helped me do. I\'ve startedand it\'s different for everybody. Everybody finds their own ways.

Speaker 2: But I looked into mindfulness, I looked into meditation, I looked into presence. II Spend a lot of time outdoors now. I do a lot of running just \'cause I really like to eat cake. So I get outside as much as I can do because I find it really grounds me and really takes me away from the computer.

Speaker 2: It doesn\'t mean I\'m not putting the same amount of effort into my life and into my work and as much passion into my life and my work, but I\'m also really thinking about stepping away from the email. And really thinking about how to make my days work best. And that\'s thethat is one of the things that consultancy gives us.

Speaker 2: I think it gives us that freedom and that opportunity to use our skills in the best expertise we can do, but also focus on ourselves as well. I

Speaker:couldn\'t agree with you more. I think balance is everything. And if I\'m hearing, if I\'m hearing you correctly, it sounds like you had that awakening moment. Was there something that happened in your life that particularly made you reflect on that?

Speaker:If you don\'t mind me asking that question?

Speaker 2: I think it was just a buildup over the years of everything that I\'d been doing and everything that I\'d, just, you get so addicted to the smartphones in your hands and you don\'t realize how much of a part of your life they\'ve become and you don\'t realize how attached you are to them when you\'re waking up, fusing them on.

Speaker 2: They\'re fussing. You do is check your emails and the last thing you do at night is check your emails. So it was just more of, I had to start thinking about things in a different way. And I wanted to just start getting more involved with myself and my life and making. My life work for me. , And that\'s, like I said, when the flexibility of consultancy, , work for me, \'cause I work for American companies, I can work in the evenings.

Speaker 2: It means that if I want to go out for a run in the morning, I can go out for a run in the morning and really connect with the earth and really feel like I\'ve been out in the fresh air before I get started for the day.

Speaker 2: But it is, there is a flip side to that, and that\'s one of the reasons Clinology came about is there were a lot of people moving into the consultants.

Speaker 2: World at the moment. We\'ve seen a lot of redundancies from a lot of the big major companies. We\'re seeing a lot of shift in change in the environment, and there are a lot of people out there. So it is a very competitive environment going out for consultancy work, which is one of the reasons I wanted to create Clinology, to make people more visible, to make it easier to find cons.

Speaker 2: Consultants to make people get the opportunity to find different expertise and not just go with the same thing that they could find. And I also felt that the, the expense of finding consultant that\'s been in the past has put people off finding them, which meant they\'ve either tried to struggle along themselves or they\'ve used one person to fill about four different gaps.

Speaker 2: Whereas with our system, they can find the right. Teams like a jigsaw puzzle, they can put in each individual jigsaw piece very simply and very, very easily, meaning they get the right thing. And one of the things we\'re looking at launching with Clinology in the next couple of months, it\'s my next progress with it, is the ability for clients to come on board and actually post projects.

Speaker 2: So rather than coming on board and just finding the consultants and saying, we want this for a long term commitment, they could come on board and say, I need someone who can write me an SLP on data management. That might just be two days work. Exactly.

Speaker:Can I have that job please?

Speaker 2: Two days. But in the old style and the old way of doing things, people wouldn\'t have done that because they\'d have to go out the recruiter, they\'d have to go out through a company and contract, and there\'d be a big commission, aren\'t it?

Speaker 2: It\'s true. I would them, they can just go out, they can post, and then all of us as consultants can say, yeah, I can do that. I can do that. So it just gives that opportunity for a lot of different things.

Speaker:There is a difference in a consultant mindset, of course, isn\'t there? And I think you\'ve touched on it there.

Speaker:Dunno what your experience has been of that shift from perm to contract, but as you mentioned, there is certainly flexibility you can build in other aspects to your life. I love the fact that you said you like to go out and feel the ground. I also do the same every morning. I walk my dogs every morning before I start my working day.

Speaker:I\'m assuming, but I\'ll ask the question. Contract versus perm. What\'s your preference? Where do you sit on that conversation now?

Speaker 2: I go both ways. I can see the benefits, of both. And I can see the, not negatives, but I can see the downsides of both. So from a contracting point of view, it is very flexible.

Speaker 2: You can make it work for yourself. You can do as much work or as little work as you need to. You can make it work around you. I was, don\'t get as involved with people. You don\'t get involved, say, with people management or anything like that. So you are very much just the consultant, the expert that comes in, does what they need to do and come back out again.

Speaker 2: And I\'ve also learned very much upfront that as a contractor I like to be very clear, and get my boundaries with my clients, as well as how much do you need from me this month? What do you need me to do? To make sure I\'m not running costs up and things like that. So I actively try and hold back and I actively try not to do things.

Speaker 2: Whereas when I was in a permanent role, I would try and do over and beyond because that\'s the person I\'m, and that\'s what I wanted to give to people and what I give to companies. On the other hand, I do miss the people management side of things. I do miss, , my mentoring. Obviously when we\'re at Mac and we have the early phase unit, we had a massive group of young people that were in there.

Speaker 2: And it was so lovely to see them all come on, see them all get this grounding, and then see them all fly and go off into some incredible roles that I still watch them to this day and think, oh wow, I remember eight years ago and you were a CTA, and now look at you like director of project management at A CRO.

Speaker 2: It\'s just. It\'s incredible to watch.

Speaker 2: And it\'s also the security. The security of a permanent role is something, because as consultants we don\'t have that security. We are al always. It is always how can we find the next contract? Where can we find the next contract? And that\'s one of the things I think within me is why I wanted to build Clinology.

Speaker 2: \'Cause I wanted to help consultants do that. Help consultants find that next contract, find their next project easier, and to reduce that fear of security.

Speaker:The way I often talk about it is, is a bit like being an actor. You know, you\'re always between roles. I feel that really, really deeply at times, particularly when I\'m between roles.

Speaker:So with regards to, you know, the consultant mindset, you just never know what\'s around the corner. You could be on the cusp of something magnificent and large and significant, or you could be looking down the barrel of three months of very quiet time.

Speaker:And that\'s just the reality of it, isn\'t it?

Speaker:Enables consultant to have a little bit more freedom and perhaps a little bit more flexibility around those opportunities. One other thing I\'m reminded of my friends in permanent roles, they get used to. A regular income pension, healthcare, and the lifestyle that goes with that.

Speaker:I don\'t think as consultants we can ever rest on our laurels, can we, we\'re only as good as the work that we\'ve just done.

Speaker 2: Exactly, it is shown in what we are doing, but also I think we get a much better experience in pivoting, in being agile because you\'re, like I said, I can have five different hats on in a week.

Speaker 2: So I go on to a lot of calls thinking, right, which hat am I on today? But I\'m passionate about all the different. Projects that I could do and I could talk about all the different projects that I can do, and I really enjoy all the different projects I can do. I never get that kind of down lift that I would sometimes get in a permanent role.

Speaker 2: When you\'re doing maybe part of the job that you didn\'t enjoy quite as much or part of the job that was the regular admin. I still get a thrill. This is really sad, but I still get a thrill sending my invoices out because it\'s just exciting. That\'s the

Speaker:best day of the month. I mean, I always send out my invoices on the last working day of the month, but I also send a reminder out to the clients that I\'m working with that that\'s what\'s coming.

Speaker:And there is nothing greater than when that invoice then lands in your business account and you know you can. You can enjoy the, fruits of your labor, but there is something tangible about that isn\'t there. There really is.

Speaker 2: There really is.

Speaker 2: And I think it is a way that the, industry is going to go.

Speaker 2: I, we\'ve seen it. Clinical research goes in waves. We see it all the time. So you go from having, everything in-house. All the companies doing everything themselves to everything being outsourced and it goes in the breathing motion. It goes out and in and out and in. And at the moment I feel running out motion where a lot of things are getting, outsourced.

Speaker 2: And I do believe that is down to many factors. I think it\'s down to the large number of small startups that are coming on board, with AI and being able to bring their molecules. And it\'s just the way that the industry is going and the downturn after COVID and the amount of companies that are reducing.

Speaker 2: So this flexibility, this insourcing, this bringing on board consultants, allows companies to breathe, allows companies not to carry that overhead, but have that really fantastic expertise that\'s out there that they need to have.

Speaker:It\'s a great analogy. I really, really like that. And you\'re absolutely spot on.

Speaker:I\'m wondering, what is your perception of where the market is at the moment? \'cause there\'s been a lot of global changes in the last six to 12 months as well alongside, the implementation of technology and AI and the availability of that. But I\'d just love to know what your bigger perspective is of what you\'re seeing in the market.

Speaker:Our audience would be fascinated to hear that.

Speaker 2: So I was having this discussion last week actually. I was at the Innovation summit in London. It was really interesting \'cause we were talking about innovation, we were talking about where things can go. We were talking about computerized systems within clinical research, and we were talking about the usual, the usual pieces that computerized systems are fantastic and everybody\'s looking for computerized.

Speaker 2: And AI to give them efficiency. But the problem is, is that there\'s so many systems and there\'s so much out there that there\'s overburden. Especially when you look at the clinical sites. When you get a clinical study and you come in and the CRO comes along and they go, we\'ve got all these different systems.

Speaker 2: We\'re gonna use this system for this. We\'re gonna use this system for your ETMF, we\'re gonna use this system for your ISF. And it\'s like fantastic. They\'re all gonna make my life easier. But there\'s 20 different systems and I\'ve gotta learn them all, train on them, all, document them all, and log onto them all.

Speaker 2: So we\'ve got to start thinking more innovatively and it\'s, it also ties into a piece of the conversation that I was having last week as well, because.

Speaker 2: I do feel we\'ve always been innovative in clinical research, but we tend to always cycle back over the same points. So I was at a conference a few weeks ago where we were talking about, patients and patient centricity, which is a real key conversation we\'ve been talking about for the past five, 10 years.

Speaker 2: But everything that came up at that conference that everything we were talking about is what we were talking about 10 years ago. It\'d be really great to get patients more involved in clinical research. It\'d be really great if we gave patients feedback on what happened on their clinical study at the end of it.

Speaker 2: So. Understand what was going forward. It would be really great if the patients who were involved in clinical research got information about where their drug was going towards the market. It\'d be really great if we kept patients up to date, kept \'em involved, help them write, get \'em involved, writing protocols, and it is starting to happen, but it\'s taken such a long time and we\'re still talking about the same things.

Speaker 2: It\'s the same things with innovation and computerized systems. It\'d be really great if it has a system that could do this. We don\'t seem to be looking for the moonshot. In clinical research, we don\'t seem to be sitting there saying, what do we need in 10 years time, like landing on the moon. We are working on what we need right now, which is actually what we needed two years ago.

Speaker 2: So although we have all these innovative systems, nothing seems fresh and nothing seems new. And I think one of the greatest examples of that is when the ICH E6 R3 guidelines just recently came out, and I think all of us read them and went, we\'re already doing all of that. We\'ve just finally written it down in the regulations.

Speaker 2: And that seems to be. The real barrier in clinical research is that we talk about innovation, but we are not moonshot. We are innovating for what we think we need right now, which is actually what we needed two or three years ago.

Speaker:So is the industry focusing on a moonshot or are we doing things the old way?

Speaker:Because the old way is the way that we know and because. I say our generation, you and I, Charlotte, we\'re doing the things that we\'ve always done because we\'ve developed and grown through this industry. And really what we need to do is throw out the rule book, start all over again, bring in all the young talent and tell us how to reinvent it from the ground up.

Speaker:Exactly. The old way is gone, the status quos are gone, and we just go, right. If we were gonna start this today, what would this look like and how would we make it happen based upon the tech that we have, the capabilities that we have, and hopefully all these great minds, not just straight from university, but those are established within clinical research.

Speaker:Is that really what you are, what you\'re talking about as well?

Speaker 2: Exactly. And the larger proportion of things today is we\'re adding tech and we\'re adding innovation to things that are already existing. Rather than saying, if we started this again from scratch, what would we do and how would we do it and how would we get this better involved?

Speaker 2: We just adding on and on and I think some of that is a side effect was being such a heavily regulated industry, and I know this one working in QA for the past three years, , is that it can be very black and white and it can be very regulated. And you get to the point where it\'s like we have to stick to the regulations and we have to do everything, that it\'s, it makes us struggle to innovate.

Speaker 2: So for an example. When we\'re looking at vendor management and we\'re looking at utilizing vendors, and this kind of ties into consultants as well, because when consultants come on board with companies, sometimes they have to be treated as vendors. We\'ve got into a process with vendors where there\'s such a regulated area around utilizing vendors.

Speaker 2: It\'s just become a box ticking vendor exercise. It\'s rather than selecting your vendor based on what you actually need for your study and what they\'re gonna give you for the study, you end up going through a reg, a regimented checklist. Of, do they have SOPs? Do they follow GDPR? Do they have this? Do they have that?

Speaker 2: And it becomes such a box ticking exercise that you are just doing it for the sake of having that documentation for the regulators. You are not actually looking at, is this vendor the right vendor for us? And can they provide us actually what we need at the end for us to advance clinical research?

Speaker:It\'s the so whats, isn\'t it?

Speaker:When you\'re auditing, you ask the whys until you get to a place of confidence. But the so what is not the question that ever gets asked.

Speaker 2: Exactly, and I think we need to do it in the next five years. I think we have to innovate because. When I look at the market out there and I look at the SMOs, I look at the clinical sites, I look at the CROs.

Speaker 2: There are lots of different companies out there, but they all do everything in the same way. Yeah. And there\'s nobody yet standing out from the crowd and yet really, truly moving things forward. And that\'s where I think we have to be from a clinical research point of view.

Speaker:So why don\'t we make that happen, Charlotte?

Speaker:Exactly. There\'s a business plan, if ever I heard one right there and then,

Speaker 2: but that\'s where I think consultants can help. It\'s getting this expertise and in this short expertise of people that are gonna come in and they\'re not embedded in the process. They\'re not embedded in the environment. They\'re come in with a completely different mindset.

Speaker 2: They\'ve not got skin in the game, in the corporation. They come in and say, actually, have you ever thought about doing it this way? And have you ever thought about trying it, doing it another way?

Speaker:I\'ve had opportunities where I\'ve gone into companies and audited them or advised on best practice, and usually that\'s been well received.

Speaker:Unfortunately, people don\'t often like to be told that their baby\'s ugly, but sometimes their babies are ugly. Right. I\'m not using the example of my kids, but anyway, unfortunately people don\'t often want to hear bad news or that they\'re doing something that they could be doing necessarily better, different, and may involve an expense around that particular innovation.

Speaker:But I think there is a mindset shift that is happening and that needs to happen within the industry to shift that one forward.

Speaker 2: And I do think it\'s amazing. There are so many health tech companies now. There\'s so many digital companies, there\'s so many startup companies and investment companies that are doing amazing things and coming up with great, amazing ideas on how, we can do things.

Speaker 2: Differently how we can make, efficiencies, how we can advance these timelines. I think we showed during COVID with the advancements of the vaccines, that there is a possibility to really pull down this 15 year timeline of getting drugs to markets. And I think by plugging in this different technology in different ways along the route, that\'s our way.

Speaker 2: We\'ve being able to reduce down that timeline and really getting things out to the people that need them, that at the end of the day, the patients and it\'s putting the patients front and center.

Speaker:You mentioned about the pandemic, I\'ll follow on from that particular point. I just wondered how you felt that the pandemic changed or has improved the drug development process if indeed it has.

Speaker:What\'s been your experience of it?

Speaker 2: I was very fortunate during the pandemic that. We kept the clinical sites, running. We kept the clinical sites open. That didn\'t mean that it wasn\'t tough. we were within the, Manchester all infirmary, as you know. Yeah. So we could see what was happening with the NHS.

Speaker 2: We kept the sites running as a shelter continued. Doing follow up visits, but we stopped doing clinical studies, especially in health volunteers \'cause we didn\'t wanna add an additional burden onto the NHS. So we got to see what was happening on the front line, how tough it was for them. And we got involved in some of the COVID, clinical research I did.

Speaker 2: I do think it really made the, authorities think and the regulators. Think, how can we do this quicker? How can we get drugs onto market quicker? And I do think, especially in the UK and all the MHRA went through a blip in 20 23, 20 24 about reg around approvals and regulations. And they\'ve really started looking at their systems and their processes and they\'ve just released some really interesting guidance, some really interesting information to get them back on track with the approvals and to keep things moving because.

Speaker 2: I\'m massively passionate about. The UK as a clinical research space, and I\'ve seen it peak and trough over the past 25 years. It used to be the forerunner for clinical research. Everybody wanted to run sites in the uk. Everybody wanted to bring clinical trials to the uk, and then it went away a little bit, and that\'s down to our regulatory environment.

Speaker 2: It\'s down to the cost that we have in the uk and it\'s down to our. Accessibility to patients, but I really think we\'re starting to turn the corner with that and starting to come back again. Get some really good innovative sites out there. Really good. Regulatory support from the MHRA where they can turn things around a lot quicker and really make the UK the place to come to for research.

Speaker:It\'s a great point you make. I was fortunate enough. To spend six months with the MHRA in a life science consulting team, and I saw it firsthand from the inside, and it was possibly one of the most transformational experiences I had. In my career that then led me into working into COVID vaccines, with AstraZeneca.

Speaker:So that period of time was really transformational from a learning point of view, but also seeing from the inside of the regulator, only having been on the receiving end of audits and technologies and documentation around them. But having seen it from the inside, I have to say there\'s a lot that needs to be improved and there\'s a lot of bureaucracy that.

Speaker:Sadly is the reason why many, many companies and much innovation is not happening in the uk, that certainly was. I think other countries around Europe particularly are really shifting the needle as far as innovation goes, and accessibility to patients and drugs to market, and that seems to be where the effort is going right now, is that.

Speaker:Is that your perception?

Speaker 2: Yeah, definitely. And it is. I think it, it\'s a whole thing of the, universe at the moment. Everything feels like it\'s struggling with bureaucracy. We talk a lot about the NHS and the amazing things the NHS does and the amazing system that it is, but. It needs to come to a point, and clinical research is the same and the regulators are the same and everything around it where you have to look at the bureaucracy, the regulation say, is this actually stifling innovation?

Speaker 2: Is, is this stifling us moving forward, and how can we better support it? It\'s like when we talked about AI before being a support structure. The bureaucracy and the regulatory has to be a support structure to enable things to happen.

Speaker:That\'s wonderful.

Speaker:Just, coming back to the ideas around Clinology.

Speaker:What plans do you have for the next year, 18 months maybe beyond that? For the platform? Have you got any particular innovations you\'re working on that you wanna share with our audience?

Speaker 2: Absolutely. Like we said at the moment, the platform is in its most basic form. The, consultants can put their profiles on there.

Speaker 2: They\'re quite detailed profiles as you know. \'cause you\'ve had to fill one in. I think when I very first did the profile and I was testing it out with our,

Speaker 2: with my web developer who I worked with, I explained to him that I want our consultants to have primary skills and there\'d be about 15 primary skills and then secondary skills.

Speaker 2: So he\'d taken that on board and he programmed it all in. And then I actually filled my profile out with him online and we were sharing a. Green and I went through and I clicked multiple primary skills and then hundreds of secondary skills. And he was like, oh, wow, I didn\'t know anyone was going to do that.

Speaker 2: And I was like, yes. We\'re consultants. We\'re very, we are very talented. We have a lot of different skills and I want us to be able to do that. So the idea is we\'ve got the profiles on there at the moment. They\'re very, standard. Clients can browse the profile. So as we increase the number of consultants to come onto the pro, onto the platform, we\'re gonna start enabling searches.

Speaker 2: So first of all, clients are gonna be able to search by primary skills. Then they\'re gonna be able to filter and search by secondary skills and buy locations, and that will come as we build up the numbers on the platform. Then we\'ve said, I\'m looking at building the projects in so that clients will be able to come on.

Speaker 2: They\'ll be able to type in a project that they need, whether it\'s long term, whether it\'s short term, put it in, we\'re gonna have AI enablement in there to help \'em write their projects. So we get a really good project plan and then we as consultants are going to be able to respond to it and pitch on those projects.

Speaker 2: We are going to hopefully be able to get a consultant network going up in there, so actually consultants can talk to each other. We can communicate with each other, we can collaborate with each other, and we can just feel like there\'s a little bit of support around us as well. We\'ve put advice out there on how to be a consultant.

Speaker 2: Things you need to know, how to, do invoicing, all that kind of thing to help people start up. So really make it a community. And that\'s where we want to go. But my real focus for the platform, I said, it\'s. Not my primary business. My primary business is a consultant, and I want to find work as a consultant.

Speaker 2: So my primary focus for Clinology is bringing as many people to the platform, letting people know about the platform, getting clients used in the platform, and getting the experts out there, the visibility that they need so that people can utilize them in the way they want to be used.

Speaker:Thank you for sharing your vision.

Speaker:I really appreciate that Shala, and, I wish you very much luck with that in the future.

Speaker:At the end of these conversations, we always finish with a quick fire round and I\'d like to pose you a few quick fire questions if I may. So what is the one piece of advice you would give to your younger self?

Speaker 2: Don\'t stress.

Speaker 2: Enjoy life, get outdoors more often. Don\'t eat the extra cake.

Speaker:What are the top three qualities you look for and value most when building a team?

Speaker 2: Credibility, trust, and I think there would probably be a word that covers it, but I will have to do a brain dump. I know my brain dump with chat GPT and it gives me a word, the confidence to fail. The confidence to throw your ideas out there and know that it might not be the right idea sometimes, or it might go wrong because we all learn huge amount of lessons from what didn\'t work.

Speaker 2: Then we learn from what actually did work and what went right, and I think that\'s a real skill that people need to have.

Speaker:One of my favorite podcasts talks about failure being data acquisition. I come back to that point, time and time again. Yeah. Failure is data acquisition. What is your favorite activity or thing that you enjoy most outside of work?

Speaker 2: Cooking. I do an awful lot of cooking, running,. I\'m not a fast runner, it\'s socializing with my friends, and caravaning and I have a caravan. So it\'s getting away again out into the outdoors.

Speaker:That\'s lovely. And finally, what is your number one golden rule for life and for business?

Speaker 2: Be present.

Speaker 2: Be present. Don\'t get absorbed in the emails. Give people time. I like being a nice person. It\'s who I am and it\'s what I am. I like to give people time.

Speaker:Thank you so much. It\'s been a wonderful conversation. All of our listeners will appreciate not just the honesty, but the true drive and dedication behind what you\'re doing, not just with Clinology, but in your own personal consulting activities.

Speaker:And having worked with you, I can absolutely ascribe to the fact that you are incredibly motivated. You get things done every single day, and. You\'re like a Duracell bunny actually. If there were an analogy, you would be that Duracell Bunny. , For any of our listeners who want to make contact with you, Charlotte, what\'s the best way that you would like them to make contact?

Speaker 2: Yeah, absolutely. Reach out to me on LinkedIn. I love making connections on LinkedIn. You can find charlie@clinology.org. But yeah, I\'m always happy to talk to people. I like having conversations with people, even if it\'s not anything that\'s going to get anywhere, just support networking. It\'s always really good.

Speaker:Thank you so much Charlotte, and thank you for coming on Pharma Prescribed.

Speaker 2: Oh, thank you so much, Adam. It\'s been a pleasure.