Clinical Operations / Project Management

Our Clinical Research Professionals are highly experienced. The majority of CRMi staff has more than 8 years of successful field experience in a wide range of therapeutic areas.

• Contract study management and study monitoring are provided through our regional network of Quality-Assured Clinical Research Associates.
• CRMi Project Managers undergo rigorous training, and most have come up through the CRA ranks. They know exactly what it takes to make a program successful in the real world.
• CRMi Medical Officers have extensive expertise in evaluating, managing and reporting safety information for IND programs, NDA/BLAs, and Postmarketing Surveillance.
• Our team of well-trained and detail-oriented GCP Auditors provide site auditing services for study closeouts, NDA/BLA preparation, as well as pre-emptive audits for cause.

CRMi also provides ongoing Regulatory Affairs, CMC, and Preclinical support to clients on a project or program-specific basis, through our network of affiliated Regulatory Affairs and Development Professionals.