Customer Feedback

Coram Clinical Trials: Study Management

Centralized Project Management Team

At Coram Clinical Trials, every project is unique and handled with the utmost attention to detail. Our quality of service, responsiveness, and ability to meet and exceed deadlines are capabilities that often set us apart from the competition.

Coram Clinical Trials can assist in protocol review to ensure homecare services are identified and compliant with protocol objectives and budgetary concerns.

Coram Clinical Trials believes that vigilant project management is the key to a study's success. The Coram Clinical Trials Project Manager is responsible for the following activities to ensure study success:

  • Scheduling a kickoff meeting to review the protocol and requirements for project management
  • Understanding technical and administrative aspects of the study as defined by the protocol
  • Developing a communication plan and effectively managing all communication among key study personnel
  • Training, credentialing and coordinating of nursing and pharmacy services to ensure subjects receive treatment within protocol treatment window
  • Monitoring study progress and alerting sponsor of any issues/challenges with sites, vendors or contract research organizations (CROs) that may impact operations
  • Monitoring the budget to alert sponsor to any change in scope requiring a contract amendment
  • Providing protocol deviation reports for any visits with a deviation
  • Providing metrics as requested by sponsor to track study progress
  • Reconciling all study-related billing activities for monthly invoice

Clinical Data Management and Health Outcomes

Coram Clinical Trials provides expertise for a broad range of clinical studies that examine the outcomes for patient usage of prescribed drug products. 

Coram is committed to helping patients achieve the best possible outcomes. We continuously capture a comprehensive array of data points from each patient we service – these data elements are gathered from admission through discharge. By better understanding how a drug is being used in a real world setting, our pharmaceutical partners are better able to evaluate the drug’s therapeutic value and thus improve practices, reduce medical costs, and ultimately improve outcomes for the patients we collectively serve. Our state-of-the-art Coram Clinical Trials program provides research services used by sponsors in both the pharmaceutical and biotech industries.

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