At Brightech, we understand the complexity and importance to generate clinical documentation. Our team consists of medical writers and physicians experienced in clinical trial development, regulatory reports and submission documents. Throughout the clinical production phase we compile all scientific findings that may impact regulatory approval as well as product sales.
Brightech’s team works collaboratively to leverage our expertise to create comprehensive, submission ready documents prepared in accordance with regulatory guidelines. Our years of experience and hands on approach has provided clients with medical and technical writing services to compile, organize, write, edit and produce a wide range of medical or scientific documents.
• Clinical development plan
• Protocol writing
• Investigator’s brochure
• Clinical Study Report (CSR)
• Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)
• Electronic Common Technical Document (eCTD)
• Safety narratives
• IND annual report
• Preparation for abstracts, manuscripts and publications