The evolution of Data Management : Biotrial at Medidata’s Paris Innovation Day
Medidata hosted the Paris Innovation Day, an event dedicated to exploring the future of clinical data science. Benoit Baron, Head of Data Management Development and Service Solutions at Biotrial shared his expertise throughout a panel discussion. With over 20 years of experience in Data Management, Benoit has contributed significantly to developing and implementing innovative solutions that improve data quality and efficiency.
The panel, moderated by Wayne Walker from Medidata, also included experts Sabrina Hadjara Petton, Head of Data Management at Ipsen and Patrick Nadolny, Global head, Clinical Data management at Sanofi. Benoît and the experts explored the recent innovations in the field and how the landscape of data management is being reshaped by advancements in technology and an increased variety in data sources, emphasizing the importance of adapting to these changes.
The journey of Data Management in clinical trials has been marked by significant milestones. From the early days when Data Managers (DMs) meticulously managed studies manually, there have been a number of remarkable transformations, beginning with the rise of Data Entry software. This evolution gained momentum with the introduction of Electronic Data Capture (EDC) systems, which significantly enhanced the efficiency of data collection and validation processes.
The true revolution in Data Management, however, started with the integration of innovative modules that have now become standards across the industry. These include :
- Coding modules, Serious Adverse Event (SAE) management systems,
- Randomization and Trial Supply tools
- Reporting and Data Visualization Tools
- electronic Clinical Outcome Assessments (eCOA)
- electronic Patient-Reported Outcomes (ePRO)
- Clinical Trial Management Systems (CTMS)
- Electronic Trial Master Files (eTMF)
Driven by continual technological advancements, these developments are part of an ongoing process that has seen global systems expand their integrated capabilities to meet the comprehensive needs of the industry. They have broken down the barriers that existed between the different elements of a trial team, making the Data Management a central and key element of each project.
Despite these advances, the future holds even more promise. The emergence of Real-World Evidence (RWE) studies and the application of Data Sciences and of Artificial Intelligence (AI) are set to revolutionize the speed and cost-efficiency of drug evaluations. Furthermore, the industry is moving towards a model where data is accessible instantaneously, and study evaluations through methods such as Risk-Based Monitoring (RBM) and targeted Source Data Verification (TSDV) are conducted with unprecedented speed.
To successfully manage these changes, DMs must evolve in both their technological understanding and interpersonal skills. Mastery over the complex digital landscape is key to driving project success. DMs will need to select and implement the most beneficial tools for each study rapidly and effectively. Moreover, enhancing communication skills and deepening knowledge of their interdisciplinary teams will be essential. DMs will find themselves increasingly interacting with a diverse group of professionals, including Principal Investigators, Clinical Operations staff, Pharmacovigilance operators, and Medical and Safety reviewers.
While Data Managers may not be central to every module, they are the guardians of data integrity. They ensure the assimilation of requirements from the sponsors and develop strategies to deliver precise data accurately and timely, meeting the expectations of all those involved in a study. As we look to the future, the merging of roles between Data Scientists and Data Managers seems inevitable. With expanding responsibilities and a growing need for advanced skills, Data Managers are set to play an influential role in the success of clinical trials.
At Biotrial, we are committed to staying at the cutting edge of these advancements, ensuring that our data management practices meet the evolving standards of the industry, thereby safeguarding the integrity and success of every clinical trial we support.
