Month: October 2016


The Most Common Reasons for Trial Rescue and How to Avoid it in the First Place

The study is behind schedule. Enrollment is lagging. The protocol is too complicated. Approximately 80 percent of all clinical studies need intervention or optimization to be successful, but only about 10 percent get it. Why? Because there is an negative connotation to the term “trial rescue.” Some Sponsors don’t want to …

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Implement CDISC Standards for Faster Reporting and Cost Control

The Clinical Data Interchange Standards Consortium (CDISC) created standards designed to streamline clinical research data and essentially enable reviewers to more fully assess the efficacy and safety of a product. In 2014, the FDA mandated that study data be submitted in conformance with CDISC standards. While research organizations are evolving …

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