Mastering the data revolution of clinical trials
Having worked in the world of Data Management for over 23 years, it’s safe to say that I have witnessed the industry change and evolve a lot, from the nearly entirely analogue methods of the 1990s to today’s almost exclusively digital approach.
Data management used to be very expensive, paper-based and inefficient, with most tasks devouring multiple human hours and being prone to human errors and other vulnerabilities. Flash forward to now - thanks to the Digital Revolution in the early 2000s-2010s – when we have shifted from paper forms and manual data entry to electronic data capture.
As a result of these changes, instead of waiting for weeks for results, users can access databases directly, update data digitally, which can be validated immediately, then extracted and analysed as needed.
Constant change and adapting processes to meet new industry regulations and client expectations have had a real and meaningful influence on clinical trials at Excelya. The fact that Data Managers, CRAs, PV, stats and sponsors alike can easily and quickly see data in real time, accelerates the way we can perform clinical research. Decisions can be made in reaction to real-time data, improvements can be realized more efficiently, and lifesaving drugs can make it to-market, sooner.
Thanks to data storage protection and the arrival of GDPR, patients can now be confident that they are completely safe and anonymous when participating in clinical trials. At Excelya, we take user management very seriously. For every study, everyone who needs access to data must be tracked and monitored and can only have access to the precise data they need to perform their work. Passwords are reset very frequently. We review matters regularly for each study, ensuring our list of users is up to date. This strict approach to compliance allows Excelya to execute internal audits frequently and with ease. This ensures that we are ready for external audits whenever necessary.
The Excelya DM future vision
We are very confident in our operational projections for the coming years and aim to have as much influence and global traction outside of Europe as we currently do within it. We have placed a real strategic focus on Asia and The Americas, and have big ambitions there, already seeing a lot of very positive developments.
These exciting advancements give Excelya the ability to grow faster and diversify our personnel, offering increased flexibility and forming a solid foundation on which to build our increasingly international team.
Some other areas for development in Excelya’s future include expanding into machine learning, business intelligence and data science. We don’t intend to rest on our laurels and have big ambitions when it comes to innovation and new tech.
This article was originally published in European Biotechnology Magazine Spring Edition 2022.