Medical Writing is an integral part of clinical research. Our Medical Writers work closely with our colleagues in the biostatistical, pharmacovigilance, project management, and clinical data management teams to deliver accurate, timely, and cost effective documents to the highest ethical and scientific standards.
Our Medical Writers have a wide breadth of knowledge and experience drawn from the pharmaceutical industry, clinical research organizations, and academia. All documents produced by Bio Soft Research undergo thorough scientific, statistical, editorial and quality control review.
Bio Soft Research medical writing services include clinical and regulatory writing, as well as scientific communications, education material and medical writing consultancy. Examples include:
Regulatory and Clinical Writing• ICH GCP compliant Clinical Study Reports (CSRs); Phases I to IV, including CSR Synopses for public disclosure