Weathering the “Perfect Storm” in Clinical Data Management — Key Takeaways from the Medidata NEXT Global Conference
Data management is evolving dramatically to address today’s challenges in clinical research. Now more than ever it’s clear that digital transformation across the life sciences industry is needed to deliver on the promise of precision medicines and necessitates the adoption of advanced technology. At the Medidata NEXT annual user conference last week, I had the opportunity to share more about eClinical’s journey with Medidata and how we see the data management function evolving as digital transformation fundamentally shifts the way life science organizations conduct business.
In 2008, eClinical selected Medidata as a technology business partner as Medidata had a vision to help transform research via technology and to help life sciences companies make the shift from paper to electronic data collection. eClinical chose a unique path by standardizing on the Medidata platform and developing a data services focused provider model and center of excellence around clinical data collection and data management that fully leveraged all the capabilities . These services have expanded over the past 12 years to form the backbone of our Clinical Data Services™ to respond to the expanding volume, variety and velocity of clinical data requirements throughout the entire data lifecycle from data collection to statistical analysis and submission deliverables.
The elluminate® Clinical Data Platform was designed to support the changing trends and data complexity that has been accelerating since 2010 and to enable modern and digital data management processes. As trials leverage more types of diverse data streams, one source of truth is needed to provide real-time data access, transparency and visibility for data review, transformation and visualization across all systems. Similar to the eClinical relationship Medidata including seven certifications across the clinical cloud, the elluminate platform, has also grown in adoption and scope accelerated recently by elluminate Data Central, a smart clinical data workbench for comprehensive data reconciliation and review across all sources including bidirectional queries with Medidata Rave. elluminate Data Central has been an accelerator for eClinical both for increasing the adoption of the elluminate platform across the industry and for increasing the speed, quality and transparency of the eClinical data services deliverables.
The Challenges: Data Complexity, Covid-19 and Digital Transformation
The eClinical team has seen a combination of several factors that have created the perfect storm in data management. Most notable is the complexity of clinical data that has grown exponentially: more than two-thirds of all sponsors are now using or piloting at least four data types, including biomarkers, omics, and specialty labs in clinical trials. Decentralized trial models, which depend on the remote collection of more data sources such as wearables and physiologic measurements, have also contributed to the data complexity. And, over the last 12 months, we are now seeing on average 8-10 data sources per trial, an extremely rapid acceleration in just one year. The Covid-19 pandemic has also served as a driving force in shortening drug development timelines. This has resulted in the call for greater private and public cooperation, as well as regulatory support, to challenge previously accepted timelines of 15 years or more. Finally, the digital transformation that is overtaking the life sciences industry means that no matter the size of the company, processes must be modernized to harness digital data streams for better, more efficient experiences in all areas of the clinical value chain.
These hurdles in drug development have shifted a greater burden onto data management teams to deliver high quality data under compressed timelines. The fact that the Last Patient Last Visit to database lock cycle times have increased by 40 percent in the last two years for companies using more than four data sources highlights the need for better tools to support clinical research teams.