Medidata and Quanticate Talk Clinical Data Management and Technology in Clinical Trials
Medidata has been partnering with Quanticate, a leading, global biometric clinical research organisation (CRO) for over a decade—supporting the company in the adoption and successful use of a variety of Medidata’s technologies such as Rave, randomization and trial supply management (RTSM), and electronic patient-reported outcome (ePRO). We sat down with Claude Price, Director of Clinical Data Management at Quanticate, to discuss the application of new clinical trial technology and improved clinical data management processes.
How did the pandemic impact the drug development process and clinical trials?
Claude: It was astonishing to see a vaccine rolled out so quickly. What really impressed me was the collaboration and how companies came together to find a solution to the crisis. Hopefully we will continue to see this level of collaboration in the future.
What are some of the challenges and issues faced when applying technology to clinical trials and how can we overcome them?
Claude: I’d say there are two main issues: the regulatory requirements that have to be met, and the willingness to adapt to new technology. Sometimes, people are reluctant to adopt or adapt to new ways of working. We need to be willing to move forward with new technology. The pandemic forced us to go more remote, and companies like Medidata have been able to help us do that in a sustainable way, ensuring that we adapt all stages of the clinical trial process whilst maintaining patient engagement and data quality.
Ultimately, the benefit of these technologies is enhanced patient care—we’ve got the opportunity to improve patients’ quality of life. The ability to conduct a large portion of a clinical trial in a patient’s home is making a massive positive difference to both them and their families.
How has clinical trial data collection changed over the past 10-20 years?
Claude: When I first joined the industry, vast amounts of data was collected, whereas now people are a lot more precise about the data they want to collect. Because patients can now use their own devices and have drugs and treatments delivered to their homes, you’re able to get data from the actual source, as opposed to the clinic—which is a trend that I think will grow in the future.
How is the evolution of virtual or remote trials impacting the role of clinical data management?
Claude: It’s about how data management teams view and review the data. Previously, their responsibility was to just collect data and send it for statistical analysis, whereas now data managers are a lot more technically experienced. Their role is expanding and will continue to expand in the future.
The data manager role will become broader and more open to different routes within their data analysis. When it comes to understanding errors, we’ve moved away from simply identifying the error towards analysing what the error means and figuring out how to deal with it.
Why is ‘high-quality data’ important?
Claude: At Quanticate, we build a lot of checks that are linked to regulatory submission requirements, which wasn’t commonplace 10 years ago. That’s where Medidata’s technology comes in, as well. With the use of RTSM, ePRO, and electronic clinical outcome assessment (eCOA), you get all the information under one roof very quickly, which allows us to analyse and interrogate it a lot earlier. Ultimately, this means you can report back on any problems, and that can facilitate an amendment or site training to address any issue early on.
It’s important to have all that information under one roof, and that’s why our relationship with Medidata is pivotal. We know and trust the system, and the fact that we have a longstanding relationship allows us to mitigate and resolve issues very quickly.
What’s in the future for Medidata and Quanticate’s partnership?
Claude: From my perspective, it’s about adjusting to new technology that’s coming in—making sure we’re accredited and certified on it and then using these across our trials. With the increasing prevalence of decentralised trials, we will be working and growing with Medidata to ensure we have everything to onboard these technologies as smoothly as possible.