Consultant Feedback

"His extensive background in product development and leadership experience have been instrumental in successfully reaching important milestones over the past few years."
Sr.Director, Vaccines and Immunology, Biotechnology Company
Clinical
Our Clinical services provide clinical consulting to ensure successful clinical compliance and submissions to all worldwide regulatory agencies. Our consulting support includes:

Submissions Management
  • Development of Clinical Development Plans
  • Clinical Trial Design and Trial implementation Planning
  • Review of Clinical Sections of submissions
  • Assist in a creation or reorganization of a Clinical Operation Department
  • Creation of Clinical SOP's
  • Provide ongoing regulatory oversight of clinical trials
  • Assist in writing Investigator Brochures/Protocols
  • Clinical Trial Application Preparation
  • Provide support in submission of regulatory documentation required for national and international Ethic Committees/IRB and IBC’s
  • Provide Support in Development and submission of a RAC submission to the NIH
  • Provide Support for a RAC advisory committee meeting
  • Provide support in creation of clinical documentations for regulatory submission
  • Ensure GCP compliance through GCP Audits and regulatory gap assessment.