Today’s clinical trials have become more complex and expensive, and pharmaceutical companies are looking for ways to improve clinical trial operations. Clinical trial data management is one area where both sponsors and contract research organizations (CROs) can uncover new efficiencies, increase cost-saving measures and be better enabled to meet the diverse operational reporting needs across the clinical development cycle. Read more in the white paper.

Even though all clinical data can be captured electronically, trials rely on several disconnected systems to acquire the data, enable operational oversight, track quality and ensure safety monitoring. With systems like an IRT, EDC, CTMS, eTMF and QMS, etc. each is likely supplied by a different vendor, hosted externally, or is a derivative of a homegrown system.

Managing trial execution requires navigating all of these sources and manually assembling data – a non-scalable and costly scenario. Not only is this process inefficient, it introduces the potential for delays, errors and variability in information gathering and creates gaps in trial oversight. Several market offerings claim to solve operational reporting needs through various “big data” approaches, however, their use in operational reporting is premature and misguided. Given that the majority of operational reports are standardized, it is more efficient to normalize the data upfront and simplify efforts at reporting time for a robust, scalable solution. Read Covance’s informative white paper which examines the current issues with traditional electronic data capture systems and other current “big data” approaches that attempt to address complex operational reporting needs in this historically stagnant and underserved area. The whitepaper addresses the use of two distinct data repositories – an operational data warehouse and a clinical data warehouse – the Xcellerate® Clinical Data Hub as part of a new data capture model through the Xcellerate® Informatics Suite to provide a significant technological advance in clinical trial operations.

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