Clinical trials form the basis of drug discovery and are an integral part of companies developing drugs, biologics, biosimilars, medical devices, in vitro diagnostics, vaccines, immunotherapies etc. Essential documents (both for interventional and non‑interventional studies) collectively permit evaluation of the conduct of a trial and the quality of the data produced to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice (GCP) and with all applicable regulatory requirements.
The whole cycle of drug development involves planning of a clinical trial, preparation of various documents (formulated as per country-specific guidelines) before/during/after the trial, submissions to regulatory authorities, and safety reporting. Documentation required during this process includes research and development related documents, pre‑clinical support, clinical trial documents, quality assurance documents, regulatory affairs documents, safety documentation post-drug approval etc. Preparation of these documents includes extensive molecule-to-product development details along with the ones supporting the drug life‑cycle management (LCM) is a tremendous task for any pharma company. A dedicated team with expertise in this drug development process is required to support pharma companies in reducing their workload.
Turacoz team of clinical research experts have expertise of developing protocols, informed consent forms, clinical study reports and investigator brochures for all phases of clinical trials and across all major therapeutic areas. The documents are ICH compliant and according to requirements of international regulatory agencies. The team also has experience on creating documents related to clinical trial disclosures and follow the recent updated guidelines by EMA, FDA and Health Canada for public disclosures.