What is your background and current role?
My career in science was forged studying Biological Sciences at University. I then worked for a number of clinical research organisations (CROs) starting as a Clinical Trials Administrator in Phase I units, before moving into monitoring clinical trials across numerous therapeutic areas and studies. I then transitioned over into pharma where I spent over eight years working in project and programme management. Having joined CRF Health in 2017, now CRF Bracket, I work with clients to maximise their informed consent process. I manage a team of project managers and project delivery specialists that are responsible for working with our clients to create electronic Informed Consent Forms (eIFCs) and deliver studies. I also work closely with the R&D and business development teams.
What does your day-to-day work involve?
Working as a team and ensuring we are all motivated, with clear goals, is a crucial part of my position. Day to day my role encompasses line management, training, mentoring, coaching and managing clients. I am heavily involved in the creation of the delivery process and the execution of the solution for studies. The ability to gather high-quality patient data via digital tools is game-changing for clinical trials and working with sales and delivery teams to train in all aspects, and keep abreast of latest developments, is crucial to handle any operational questions. With insight from sponsors, sites and patients and monitoring the regulatory landscape, I ensure our delivery teams can provide clear guidance to clients to achieve eConsent delivery and approval and steer efficient operational delivery processes.
Why is your area of work of particular interest to you?
Having previously worked in clinical operations at both pharma and CROs, I experienced first-hand the challenges and frustrations of paper ICFs. This exposure to clinical trials and ICFs across global studies, covering paper ICF writing, monitoring and reviewing, has enabled me to appreciate just how important an efficient and effective consent process is. I have learnt to my cost what the challenges are and can now seek to set the record straight – literally! With paper consent, challenges arise around version control, lost forms, patients not being consented or consented for the wrong study, or sub-studies not being consented for, all creating deviations and issues. In terms of project management, tracking these protocol deviations and having to make decisions around what data can or can’t be used when analysing study results, whether sites need to be closed out and reporting to ethics committees - these are all issues that I can now address in my current role, improving patient comprehension in clinical research and building on the recommendations from regulatory bodies such as the FDA’s Guidance on informed consent, and industry guidance such as TransCelerate and the Clinical Trial Transformation Initiative’s (CTTI) recommendations for improving approaches to informed consent. It all allows for greater consistency and control in the informed consent process thereby limiting regulatory risk and ensuring accurate, timely and reliable data capture and management.It suits me too on a personal level - I am driven by a need for efficient processes and luckily for me my job is centered around that, making clinical trials more efficient.
What is a key frustration of your job?
There are not enough hours in the day! I work with people across lots of time zones, Japan, EU, US, Romania and Finland so my day is always extra busy, when one person’s day is ending another is starting which enables us to work around the clock across all the different time zones.
Do you believe medicines developers are currently making the most of new technologies to improve their clinical research practices?
In terms of pharma and eConsent adoption, I think there is still a lot more to be done. Uptake has been a little slow, however I think clearer guidelines are needed. We operate in a highly regulated environment which can slow the adoption of new approaches, including new technologies. While there are guidelines, nothing is mandatory, but this may change in the future. TransCelerate will be publishing the results of its latest eConsent survey soon which the industry is eagerly anticipating, which will help inform future uptake.
What do you see as the key opportunities new information technologies could offer pharma?
Undoubtably, the hot topic of the moment is patient centricity, and we are seeing increasing emphasis on designing more patient friendly studies that utilise patient-facing technology in all aspects of clinical trials. eConsent and patient engagement products complement each other, and patient portals where everything can be found in one central place, hold promise for patients to reduce their burden of participation.
What are the main barriers to uptake of such technologies in Europe?
I think there are some misconceptions around uptake in Europe, with regulatory uncertainties and industry ambiguity adding to this. In terms of eConsent, for instance, Germany does not accept electronic signatures, a paper signature is still required. However, hybrid eConsent solutions can allow for that so this is not really a barrier. The US is ahead of game, owing to the FDA guidance which was published earlier than the guidance issued by the MHRA. I think it is more of a perception issue that uptake in Europe is slower when it is not actually the case. We see interest and pioneering work conducted by biopharmaceutical companies across the globe, and certainly from Europe.
What do you consider your greatest achievement to date?
I’m certainly proud of some of the innovative new products I have shaped. Undoubtedly, my greatest achievement is being part of building the first delivery team for CRF Bracket’s solution in this area, finalising and rolling out the product across the company. Implementing the training for this new product and seeing the team work towards a common goal was inspiring.
What are your passions outside of work?
Photography – weddings, christening, places! People and places – recording how things change over time. Sounds like I am back at work…