Project Consulting & Vendor Management

Manage all aspects of the clinical study from pre-clinical programs, protocol writing, start-up feasibility, regulatory and ethics submissions through final Clinical Study Report delivery with timely top-level results.

We will create achievable project timelines with MS Project, tailored according to regulatory and ethical framework in the region using our extensive knowledge and experience and provide complete oversight to assess, appoint and manage study vendors to ensure your clinical trial is adequately and uniquely supported including central laboratories, drug distributors, IWRS system providers, EDC systems etc,.

The execution of all contracted responsibilities will be in accordance with ICH GCP/ ISO 14155 and local guidelines.