CLINICAL DEVELOPMENT - 'From patterns to procedures'

Provenance's Clinical Development team conceptualizes and develops effective and scientific study designs, protocols and Informed consent forms for our clients to conduct clinical trials in consultation with specified therapeutic area experts ensuring compliance with applicable regulatory guidelines.

Provenance's in-house study start up team prepares and provides accurate documents through an intensive internal review and quality assurance process. They integrate and interpret important and relevant information from the existing sources of information into the clinical trial documents like protocol and clinical study reports.

Provenance's medical writing team works closely with biostatisticians, clinical operations team and collaborates with project team members to produce concise and comprehensive clinical trial essential documents for Regulatory submission giving due importance to study timelines.

Provenance's Medical Affairs team assists sponsors/clients conceptualizing and formulating a successful strategy to design, prepare, review, and implement an elaborate medical-management plan.

Provenance's Medical Monitoring and Pharmacovigilance team provides medical monitoring oversight to ensure that trials are conducted in accordance with the specific study protocol and applicable regulatory guidelines. Medical monitors are always available to provide answers to queries related to patient eligibility/patient management. Clinical Development professionals provide highly credible input for the design of safety management strategies and plans, to support regulatory acceptance of documents.