New Opportunities for Leveraging Operational Data in Clinical Trials


Clinical trials have always been complex endeavors but unfortunately, current tools aren’t keeping up.  Teams report challenges managing the complexity and milestone achievement challenges across a portfolio of trials. The challenge begins with the data from each of the trials being siloed away in incompatible EDC, CTMS, safety and lab systems. A recent survey of ClinOps Leaders indicated that only 8% have automated the decision processes necessary to achieve critical milestones.
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Better Study Startup Means Less Study Rescue


When a clinical trial does not unfold as planned, it may be heading for rescue. Communication problems among stakeholders, patient enrollment delays, overly complex protocols, and poor site compliance are just a few of the many reasons why rescue action is needed. The issue of study rescue is increasingly faced by contract research organizations (CROs) as it has been estimated that by 2020, 70% of all clinical trials will be outsourced to CROs, a trend that frees sponsors to re-focus their energies on core competencies. With this model, the goal of better on time and on budget performance—essentially avoiding rescue—has often become the responsibility of the CRO. But what happens when a rescue is needed and what can CROs do to avoid it?
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Clinical Trials Sponsors and Sites Come to Terms with Medicare Reporting Law


Section 111 of the Medicare, Medicaid and SCHIP Extension Act (MMSEA) of 2007 impacted both clinical trials sponsors and clinical trials sites, but as awareness and compliance among the Pharma 15 has grown, the pharmaceutical industry has adjusted and trial sites are becoming more accustomed to providing the required patient information. This article will address both the sponsor’s requirement to report and the impact and advantages to clinical trial sites of reporting.
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