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Endpoint Evaluation


 

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CPC has developed a unique program aimed at improving the assessment of primary and secondary endpoints in clinical trials. Many trials that employ symptomatic or functional endpoints have experienced problems with endpoint variability and excessive placebo responses. Each of these issues result in data that makes it difficult or impossible to interpret the effectiveness of a drug or treatment intervention.

CPC has developed tools that strictly standardize the methods used in collecting and recording endpoint data, resulting in data that more truly reflects the treatment effect through decreased placebo responses and decreased variability.

This program involves a combination of:

  • Hands-on-training of endpoint data collection at Investigator Meetings

  • Web based training of endpoint data collection for research sites

  • Site Endpoint Evaluation Visits at the sites which involve both training and in depth assessment of the site's procedures

  • Endpoint Evaluation Committee Meetings to review all issues noted at the research sites

  • Written follow up provided to the research sites regarding the issues noted during the SEEV and recommendations from the Endpoint Evaluation Committee

  • Reference and training documents designed specifically for each individual project

  • Sponsor training on endpoint data collection and monitoring endpoint data collection

  • Case Report Form design for endpoint data collection

  • Study specific source document design for endpoint data collection