The process of ensuring clinical trial records are accurate
and fully reconciled between laboratory and clinical data sources can be a
point of frustration for today’s pharmaceutical and biotechnology companies.
Whether the data is coming from a contract research organization (CRO), a
central laboratory or third-party laboratories, the need for timely
availability of clean data based on unique sponsor format/industry requirements
has become extremely complex.
“As the complexity of today’s studies grow, sponsors are
often working with a greater number of laboratories in their studies,”
explained Richard Cesarski, SVP, Patient Solutions, Safety and Data Sciences. “While
these labs are specialists in sample management and generating results, their
standard report formats may not be aligned to individual sponsor requirements.”
Recognizing this gap between sponsors, their clinical
partners and the labs, Covance has launched Laboratory Data Management FSPx
(Lab FSPx), a new solution within its Functional Service Provider (FSPx)
In 1848, the most famous Gold Rush in American history began at Sutter’s Mill near present-day Coloma, California, shaping the US economic map forever. In those days, there were no scientific tools to guide prospectors in their search. Sites of previous finds were the starting point for what became, for many, a shattered dream.
Today’s clinical trials have become more complex and expensive, pressuring pharmaceutical companies to further improve their 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 better meet diverse operational reporting needs across the clinical development cycle.
In this blog we begin to examine 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. We also discuss 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 model through the Xcellerate Informatics Suite to provide a significant technological advance in clinical trial operations. Continue reading →
Demonstrating the efficacy, safety and differential benefit of a new drug relies on collecting and analyzing enormous amounts of data generated in a clinical trial. Yet this process of extracting knowledge from data is often the source of many inefficiencies.
We recently spoke with Dimitris Agrafiotis, PhD, Vice President and Chief Data Officer at Covance to hear his thoughts on how informatics has affected drug development and will continue to transform the pharmaceutical industry.
Q: Why is informatics important in a global context?
More and more major businesses and industries are being run on software and delivered as online services―from movies to agriculture to national defense. Many of the winners of this new economy are Silicon Valley-style technology companies that are invading and overturning established industry structures. Continue reading →