Dr. Pratibha Rauthan Email and Phone Number

• Creating and writing protocols, and presenting these to the steering committee.• Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.• Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial.• Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.• Liaise with the ethics committee regarding the rights, safety, and well-being of… Show more • Creating and writing protocols, and presenting these to the steering committee.• Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.• Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial.• Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.• Liaise with the ethics committee regarding the rights, safety, and well-being of trial subjects.• Clinical Data Monitoring & Management • Protecting subjects’ confidentiality, updating their information, and verifying IP have been dispensed and administered according to protocol.• Conducting regular site visits, coordinating project meetings, and writing visit reports.• Implementing action plans for sites not meeting expectations.• Liaising with regulatory authorities. Show less