MEDICAL TRANSLATION

Medical Writing is a central part of clinical research. Our Medical Writers work closely with a team with expertise in the biostatistical, pharmacovigilance, project management and clinical data management sectors in order to deliver accurate, timely, and cost effective documents to the highest ethical and scientific standards. We can provide low cost writing services due to our unique distributed management structure.

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 Latin Link undergo thorough scientific, statistical, editorial and quality control review.

Latin Link’s 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
• Study Protocols
• Clinical and non clinical sections of the Common Technical Document (CTD) including summaries and overviews for EU or US Regulatory Authorities
• Investigator Brochures
• Patient safety narratives
• Patient information including Informed Consent and Patient Brochures
• Pharmacovigilance documents such as Periodic Safety Update Reports
• Standard Operating Procedures (SOPs) covering all aspects of drug development including the design, conduct and reporting of clinical trials and the outsourcing of Sponsor responsibilities to a Contract Research Organisation (CRO)