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About CAPClinical Assistance Programs (CAP) is a clinical trial consulting company focused on assuring consistency and quality of study endpoint measures. The CAP business model evolved from the demonstration that the probability of clinical trial success can be greatly improved when clinical investigators are rigorously trained to assess and score clinical trial endpoints. Likewise, study data quality is enhanced when CRAs and other study team members have a thorough understanding of the clinical meaning of study endpoints. CAP’s programs of endpoint training, CRA/CRO education and outcomes management have been proven to be valuable and effective, particularly for trials in which endpoints are based on clinician-dependent measurements. The implementation of CAP’s endpoint training and outcomes management programs provide the clinical study supervising team with a level of confidence around endpoint validity that was previously considered unattainable. Repeatedly, study sponsors have noted that the inclusion of a CAP program resulted in a dramatic and demonstrable reduction in investigator and evaluator errors and improvement in the consistency and accuracy of endpoint measurements. CAP’s services have been well-received by the FDA and other regulatory agencies and are fast becoming a useful and valuable resource for knowledgeable clinical research professionals. CAP utilizes only nationally-recognized clinical experts and thought leaders to oversee its endpoint training and outcomes management programs. These experts participate actively and longitudinally in the study providing meaningful guidance support and feedback from start to finish. In addition, CAP has been providing endpoint training and outcomes management services for more than a decade and has participated in numerous studies at all stages of clinical development. CAP’s client list contains the names of many of the largest pharmaceutical and life science companies in the world. As a company with experience in Western Europe, Eastern Europe, Australia, India, the Far East and North America, CAP can provide endpoint training and outcomes management services virtually anywhere in the world and utilizes local trainers speaking the native language whenever possible. CAP has spent more than a decade building a respected team together with a broad network of educators and investigators to assure high quality outcomes regardless of venue. *CAP is affiliated with Biomodels, LLC, a preclinical CRO co-owned by Brigham and Women’s Hospital, a Harvard Medical School teaching affiliate. |
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