The clinical development plan is intended to provide a rationale for the clinical indications and clinical anticipated dose and/or operation setup and design selected for your investigational product. It is aimed to generate evidence based information for the product safety and efficacy as well as supporting the product label wording.
B.R.D. provides a broad range of CRO Services offering you a complete spectrum of services covering the full study management environment designed to make your trial a success. B.R.D. has helped numerous clients successfully manage the transition from preclinical development to clinical studies, enabling them to make effective and fast decisions about the safety and efficacy of their investigational product.
B.R.D. CRO has great experience and know-how in executing clinical trials from First-in-Human trials through Proof-of-Concept to Post Marketing Studies for a wide range of pharmaceutical, biotechnology and medical device companies.
B.R.D. CRO consists of a medical writing unit, clinical operation unit, data management unit and the clinical regulatory unit, operating in harmony to offer and deliver high level support during the design conduct and trial closing stages to assure full compliance with ICH-GCP and other regulatory requirements, and constructing of the statistical and study report in a timely manner.
For full details of B.R.D. CRO activities please refer to CRO Services: