Sholeh Ehdaivand has worked in clinical research for over 20 years and has a true passion for making a difference in people’s lives by aiding the development of newer, better healthcare solutions. Having launched LMK eight years ago, the business has continued to grow driven by Sholeh’s passion for innovation and improvement. Using her expertise in the field, Sholeh worked with her colleagues to develop and launch TMF University, an IAOCR independently accredited training program carrying Continuing Professional Education (CPE) points built specifically to upskill those who work in TMF.
- How did you get into the clinical research industry and what career path did you take?
I didn’t take the most obvious route! I was actually working in insurance, but really not enjoying it. One day I was talking to a friend who worked for a CRO and I became very interested in what they were saying, it really struck me. Clinical research was something that would actually impact people’s daily lives. It directly affects their health and that immediately appealed to my desire to make a difference.
A position opened up at this CRO and I bit the bullet, applied and was successful. It was a steep learning curve as a project coordinator but it helped introduce me to the different areas of study that clinical research can span. I got involved in regulatory submissions and meetings, safety, Trial Master File (TMF), sponsor meetings, and everything in between. It was a great first job in clinical research and I would encourage anyone entering the industry to start as a project coordinator. For me, working with sites and monitoring was the most interesting, I loved the travel but that got tiring so I settled into study management which provided the variety I liked and served as a great springboard.
- How did this lead to the creation of LMK?
Having worked for a number of CROs as well as sponsor organizations such as GSK and Pfizer, I decided to go off on my own and do some contracting; I knew lots of people contracting and the opportunity to work on numerous types of projects appealed to me. At that time, I’d been in the industry for 10-12 years, had the experience, specialized in neurological studies, and also had a good network. I started to do the contracting work and it was great. Once people found out I was contracting, the opportunities kept coming up and I soon realized I needed to hire people. Eight years later—and here we are. It’s been very organic but also very exciting.
- What do you think is the biggest challenge for clinical research organizations? How can this be addressed?
A year ago would be a different challenge from today. In some respects, clinical research is a very archaic industry. We still work a lot with paper and I don’t think we use technology to our advantage. It feels more like an afterthought than an efficiency. I think 2020 has pushed us into becoming more technologically advanced, which has pushed us out of our comfort zone for the better.
We could do so much more if we proactively used technology; we could advance medicine further and take things to the next level. I think it’s a matter of turning the dial and embracing technology. It can help with patient recruitment, managing protocol deviation, capturing data, and so many other areas. Documentation is a big investment for companies, and often results in a big push at the end of the study.
Over the past 12 months things have changed significantly. This has become our “new normal” and rightly needs to be as we’re going to be in this space for a long time.
- Why did LMK develop the TMF University and why do you think it’s so important?
I first thought of the concept of TMF University in 2015 as I wanted a forum where people could increase and expand their TMF knowledge through information. Working with my team, specifically Jackie Morrill our Executive Director of Clinical Operations, we knew that we wanted to give people the right information and educate the industry on the importance of the TMF.
For us the value of TMF University is clear; TMF professionals need the best development courses to take their careers to the next level. Historically, the TMF and TMF roles have been predominantly administrative, but following the emergence of the TMF Reference Model – a standardized taxonomy and metadata that outlines a reference definition of TMF content using standard nomenclature, the TMF is inherently important. TMF is effectively a sub-industry of clinical research and it needs to ensure the opportunities are there for those working in this field.
- How do you think the TMF University programs will help to reduce risk to clinical research?
One of the things we repeatedly see is the waste in TMF; it often comes down to the end of the study and the teams are scrambling to get documentation finished, located, QC’d and ready for inspection. This might have been OK in the past, but regulations – and by that I mean the MHRA, EMA and ICH (what the FDA follows) – expect the TMF to be completed contemporaneous to the clinical trial itself. This makes it clear that it needs to be filed on an ongoing basis and waiting until the end of the study is not an option. It is important that companies have that mindset that they need to finalize TMF documents as the trial continues to an inspection-ready quality; this comes down to a mindset change.
We need to view the TMF as a clinical trial management tool. It can help manage the progress as to whether a site is ready to receive the drug, be closed out or reach 50% mark for randomization – by using the TMF this can be done via documentation and will eventually improve efficiencies. These developments are key factors that have driven the development of TMF University, using the TMF as a tool to improve efficiencies, reduce timescales and ultimately improve the inspection outcomes.
- What do you think the top three challenges are for our industry in the next few years and how can we address them?
1. Diversity: we need to have patients that look like the world around us, and that will be improved through education. All the clinical trials and vaccines related to COVID-19 have highlighted the disparities in clinical research due to the spotlight on it. This is something that has evolved over the years and is something we need to fix; lots of people are talking about this but not the right people… yet. We need to educate ourselves on the different elements of diversity we need to embrace and then make a step to address those challenges and needs.
2. Technology: I believe technology is central to the industry’s future. If we use technology in the right way it can truly benefit us and expand the industry as well as the opportunities therein. We need an open mind to doing things a different way, and this will make us more efficient. Technology can help us do things faster, close timelines, save money and ultimately that’s what everyone wants to do. TMF University serves an important role in helping with this because we need people who are savvy working these technologies and implementing them. It’s very expensive to develop a drug, but technology can help to reduce the costs and I think it’s important that we invest in it.
3. Regulation: Over the past 10 years we have seen so much come from regulatory agencies in terms of expectations, how to run clinical trials, etc. We need to understand the expectations from regulatory agencies and have open dialogue with the regulatory authorities so we can understand what their exceptions are. This will allow us to be more compliant. We have just received the ICH e8 update – modernization of clinical trials – which is big step in the right direction for accepting technology and is positive step for the future. We’ve also received the ICH GCP release 3 (e6) which is a huge update. But what these specific updates reflect are regulatory changes. These will start to be echoed in individual countries and regions as they update their regulations for alignment. Increased harmonization across the regulatory agencies will allow for the harmonization of key elements of clinical research, including TMF.
- What excites you most about the future of the clinical research industry?
The breakthroughs and the developments we’re seeing at the moment are very exciting. The fact that scientists were able to break the genetic code for COVID-19 in a matter of months is unbelievable.
More cures for more diseases and more vaccines can only be a good thing. I’ve recently learned about a Korean lab that is working on a vaccine for breast cancer. It’s an exciting time to have the intersection of technology and science and to see where this takes us.
- What company within clinical research inspires you and why? How do you think you can learn from it?
Personally, I take inspiration from so many places. For example, Halloran Consulting Group is a female owned consulting group, led by a true expert in her field, Laurie Halloran. In my opinion, she has taken clinical research to the next level. Furthermore, she’s transformed the business into employee-owned which demonstrates her innovative approach to business.
I also love to see what smaller biotech companies are doing. They do something new every single day and that makes me want LMK to be that innovative as well.
- Do you think the industry is taking on board the competence philosophy and mentality?
Absolutely. It’s a very competitive job market in clinical research; it is very demanding industry and I think we’re finally starting to recognize that. Competency has to underpin everything we do in the industry. We’re starting to see companies focusing on recruiting people who are very well trained, and have extensive experience. Ultimately, that’s going to save them a lot of time and money —and it just makes good business sense.
With respect to IAOCR and the work they are doing in clinical research, they are truly helping us create professional development programs that are so needed. I’m very glad IAOCR exists but not just for us. They have developed many other programs with the intention of helping professionals and businesses develop and strive for high industry standards.
- What advice would you give to someone starting out in their clinical research career?
There are so many different jobs and career paths in clinical research it can be daunting. Starting in a role such as a project coordinator allows you to work with people who are in a variety of roles from which you can then make an informed decision.