By Katrina Rice, Chief Delivery Officer, Data Services
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 ASCEND 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.
Recording: Katrina Rice, Chief Delivery Officer of Data Services at eClinical, delivered the keynote presentation, ‘Modernizing Data Management in the D-Clinical Age’ which had the 2nd highest number of attendees from any presentation on Day One of the event.
The Solutions: 3 Key Points to Addressing Current Challenges in Clinical Trials
There are several areas that can be modernized right now to respond to current trends and to prepare for future data transformations:
Improve efficiency throughout the data pipeline by automating manual processes. In doing so, companies can ensure that data ingestion is seamless and that data is readily accessible to all stakeholders. Invest in clinical data platforms like elluminate to make this automation possible.
The FDA’s recent guidance on the conduct of clinical trials for medical products during the pandemic has brought risk-based approaches to the forefront for clinical trials. These models highlight the importance of remote monitoring and the need to focus on critical data and points of failure. Tools that can quickly identify these data points will be crucial in protecting patient safety and sustaining ongoing participation in studies.
Data sciences are the key to unlocking the insights in valuable clinical study results. Improve the understanding of data sciences techniques by focusing resources on training team members so that they can build their technical knowledge. This expanded knowledge base will also allow companies to adapt to new platforms and enhance the customer experience for all key stakeholders.
Digital transformation in data management is now a strategic imperative for all life sciences companies. By investing in technology, improving processes and upskilling teams, clinical data management can move forward into a new age, where delivering high quality data streams can lead to greater insights and more treatments for patients.
To learn how the elluminate clinical data platform combined with the Medidata Clinical Cloud and eClinical Data Services can help you regain control of your data and move into the ‘D-Clinical Age’ of data management, contact eClinical to learn more.
Chief Delivery Officer, Data Services, eClinical Solutions
Katrina Rice is an accomplished Chief Delivery Officer with an impressive career that spans over 20 years and includes advancement into increasingly demanding leadership roles. With a solid history of leading business transformations and managing global portfolios, she is as much at home scaling operations as she is in developing strategies that drive revenue growth. At eClinical Solutions, Katrina was recently promoted from Executive Vice President of Professional Services to Chief Delivery Officer. She has previously held various technical roles at Lockheed Martin Energy Group and Bayer.
Katrina holds a Bachelor of Science degree in Computer Science from Alabama Agricultural and Mechanical University and a Master of Science degree in Computer Science with Advanced Applications from the University of New Haven. In her free time, Katrina is an active participant in several organizations including the Healthcare Businesswomen’s Association and Women of Color in Pharma. She is also a Member of Chief, a private network for women in senior leadership roles, a Board Member of the Central Connecticut Coast YMCA, and a Member of the Delta Sigma Theta Sorority Incorporated.