Site Quailty Program

CPC has developed a unique site quality program aimed at improving the collection and assessment of 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 results in data that make it difficult or impossible to interpret the effectiveness of a drug or treatment intervention.

CPC has developed a program that standardizes the methods used in collecting and recording endpoint data, resulting in data that allow for better assessment of the treatment effect by decreasing placebo response and variability.

This program involves a combination of:

• Training on endpoint data collection at Investigator Meetings
• Web-based training videos and quizzes for endpoint data collection at research sites
• Site Endpoint Evaluation Visits (SEEV) at the research sites, which involves both training and in-depth assessment of the site's procedures
• Weekly review of issues noted at the research sites by the Site Quality Advisory (SQuAd) Committee
• Written follow up provided to the research sites regarding the issues noted during the SEEV and recommendations from the SQuAd Committee 
• Reference and training documents designed specifically for each trial
• CRA and Sponsor training regarding endpoint data collection and monitoring of endpoint data
• Case Report Forms and Source Documents custom designed to optimize quality collection of endpoint data