Clinical Development
Clinical Development Program needs technical support to make the Clinical Studies a success.
Clinical Trial Supply
DWC can support all activities of Clinical Trial Supply for Phase 1 to 3 clinical studies together with best-in-class contract manufactures, which includes:
– Manufacture of Investigational Medicinal Product (IMP)
– Design of packaging configuration
– Primary and secondary packaging
– Blinding – placebo and active comparator-controlled studies
– Storage and distribution of IMP
– Batch release of IMP by Qualified Person Services
Clinical Trial Support
Support of all stages of a clinical trial, including identifying an investigational site and setting up, initiating, monitoring and closing out the trial,
Supervising the conduct of clinical studies:
Designing CRFs, Protocols, and Essential documents.
Engaging medical writing
Managing regulatory authority and EC/IRB applications and approvals.
Integrated part bio-analytical tests of stability plan of the clinical formulation batch during the clinical study.