How Data-fueled Performance Gives CROs a Competitive Edge
CROs are awash in data today. Growing volumes of patient-reported outcomes, omics data, and data derived from wearable/biosensors are collected from almost every patient who joins a trial. Over a single decade, the number of countries participating in trials rose 100%, the number of investigative sites joining trials rose 63%, and the number of procedures measured by trials jumped 70%. This data crunch is not limited to trials themselves. Post-trial follow-ups with trial participants are also up 25%.
Despite the large volume, this data might not be sufficient to answer the research questions you’ve set out to study. Relying on in-house data and tools is not enough to evolve with digitization trends in the era of COVID-19. Delivering an end-to-end experience for your sponsors starts with implementing a data-driven approach to understand what’s happening in your trials in real-time, and powered by a platform with the most comprehensive data in the industry, across 20,000+ clinical trials, touching 5.8+ million patients throughout 22,000 sites and 94 countries.
Data on a unified platform creates a single source of truth—editing or modifying data in one location changes it everywhere, eliminating the need for manual updates across disparate data streams. This ensures transparency among users and mitigates potential risks to timelines and budgets.
On a unified platform with real-time data streams, CROs and sponsors strengthen relationships with immediate trial updates. The increased collaboration and insight derived from a unified platform reduces study build time, saves money on unexpected data migrations and transfers, and speeds up data reconciliation and cleanup to improve decision making. This ultimately expands revenue opportunities for CROs, which gain the edge of real-time data and deliver guaranteed efficiency for sponsors.
Expand revenue opportunities
Sponsors expect CROs to proactively modernize their approaches to clinical trial processes, adopt new risk-based monitoring practices, and maintain the highest standards in technology and transparency. Especially in the age of COVID-19, CROs experience mounting pressure to adapt, respond, and demonstrate competitive advantages.
In April 2020, the Medidata Professional Certification Program reached a major milestone—200,000 combined Rave Certified Clinical Research Coordinators (CRC) and Principal Investigators (PI) for Medidata’s Rave Electronic Data Capture Solution. This number represents 200,000 investigators and coordinators who elected to be formally certified when they completed their Rave Electronic Data Capture Solution eLearning and testing. This large number of optional certifications is a reflection of the dedication of our site users, the high quality and reliability of the Medidata platform and its support services, and our close relationship with our sponsors and partners.
Medidata also has a dedicated, global Strategic Consulting Services team which identifies new opportunities for our partners. Through its portfolio of readiness assessments (RAs), Medidata experts partner with you to identify gaps, assess existing tools and resources, understand best practices, and move towards streamlined and data-driven decision-making. This process uncovers practices and tools to drive a value-added approach, eliminate wasteful or redundant effort in your trial execution, and transform to a higher profitability model.
Based on readiness assessments, CROs identify new ways to attract and retain sponsors as customers by providing visibility and validation for technology solutions and capabilities. Assessments create paths to drive new or increased revenues in untapped management areas of clinical trials, while building confidence for sponsors seeking an innovative approach to risk-based monitoring. With systematic or project-specific assessments, CROs guide sponsors more efficiently, delivering greater value for both their clients and their bottom line.
Gain the edge of real-time data
Sponsors increasingly call on CROs to effectively leverage an expanding set of research, clinical, operational, and real world data (RWD) to accelerate their trials and improve their chances of successfully launching new drugs. While data and advanced analytics hold great potential, accessing fit-for-purpose data sources, standardizing and integrating datasets, deriving actionable insights, scalability, and change management are major challenges along the way.
CROs attract more bids and stand out from the competition with access to the industry’s best data repository and pre-built analytics. A data-driven planning approach to reduce trial complexity and improve disease understanding results in faster trial timelines, increased win rates, and lower costs. With fit-for-purpose data sources at hand, CROs can offer better analysis of clinical trial data and real world data to build predictive models in ways that traditionally have not been possible.
From a risk mitigation perspective, a paradigm shift towards integrating risk-based quality management into daily clinical practice helps sponsors and CROs better understand data trends and patient outcomes while identifying unanticipated data anomalies. Unknown or unexpected data and events can have significant impacts on data quality and study results, and data issues are more common as trial complexity increases.
CROs have opportunities to grow their business through the power of machine learning and real-time insights for prediction, remediation, and ongoing performance improvement. Detect issues proactively, including inclusion/exclusion criteria violations, protocol violations, and other compliance or performance red flags to keep your trials on track.
Deliver guaranteed efficiency
The Medidata Enterprise Data Store (MEDS) frees your study teams from the time and effort-intensive activities of multiple system integrations with a unified tech solution that protects data integrity and accelerates timelines. MEDS allows CROs to offer a full-service engine to simplify and unify trial data for sponsors.
By delivering the data they need, when and where they need it, study teams are freed from manual input or review processes, able to devote more time and effort to higher output initiatives, and able to execute trials faster and with more confidence knowing they are working from the same single source of high quality data.
Working on the Medidata Rave Clinical Cloud, patients can be simultaneously auto-enrolled, consented and randomized by using Rave eConsent, Rave eCOA, Rave RTSM, and Rave EDC. This ensures that the right treatment is delivered to the right patient at the right time, automatically eliminating the need for multiple data entry.
 Tufts Center for the Study of Drug Development, July/August 2018