Clinical Project Management

Throughout the years of its operation B.R.D CRO has gained extensive experience in a broad range of therapeutic areas and has established strong working relationships with the leading physicians in their field, in most medical centers and health care clinics across Israel.

As part of the preparations for clinical research and before the clinical study starts B.R.D professional team may provide the sponsor  company and/or the Investigator (in investigator initiated studies) with the required information and appropriate scientific perspective they need for strategy optimization and their clinical study design. B.R.D CRO offers expert consulting and assistance to ensure that all the pre study activities according to a specific set of operations were taken into consideration to meet project needs and provides customized support advice and solutions designed to accomplish a successful compliant clinical trial, its smoothly regulatory approval and valid outcomes.

Project management services include:

  • Study Feasibility Assessment (including risk-mitigation analysis)
  • Early Statistical Input (Sample size calculation, randomization method)
  • Protocol Development (based on client’s SOPs/template or our own)
  • Study Budget Development
  • Identify and Secure IMP Clinical Supply Chain
  • Identify and Secure Ancillary Clinical Supply Chain  
  • Project-specific Tailor-made Laboratory Logistics
  • For project management activities during study conduct see Clinical Operations

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