ECLINICAL INSIGHTS

  • Establishing TMF Quality Goals For Greater Trial Efficiency

    Does your clinical development group rely on its TMF as a resource for designing and conducting trials efficiently? Would maintaining timeliness in filing complete, ALCOA-compliant documents to the TMF be enough if efficiency were a goal of every clinical trial? Consultant Ken Keefer discusses the importance of creating TMF quality goals to improve overall trial performance.

  • Understanding Data Collection And Management In Decentralized Clinical Trials (DCTs)

    When it comes to wading into the muddy waters of a DCT, it's important to specify the risks up front and determine how decentralization is appropriate for each protocol. From a data collection and management standpoint, there is plenty to consider in terms of data flow management through multiple sources and systems.

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