MEDICAL WRITING
Manage constantly evolving regulatory protocols and submission guidelines with our experts. Get collaborative, affordable support for clinical, data management, and biostatistics groups — whether you need minimal support or a whole team. From protocol development to regulatory support to publishing, our expertly prepared reports comply with local and ICH guidelines.
Our experts support writing and regulatory services to ensure complete, compliant, and high-quality deliverables. Receive documents that have undergone rigorous scientific, statistical, editorial, and quality control review, compliant with FDA, EMA, and other regulatory requirements.
Services cover medical and regulatory writing, scientific communications, and publishing. These services include:
Medical and Regulatory Writing:
- ICH and GCP compliant clinical study reports (CSRs) – Phases I to IV
- Including CSR synopses for public disclosure
- Study protocols and design
- Clinical and non-clinical sections of the Common Technical Document (CTD)
- Summaries and overviews for EU and US Regulatory Authorities
- Investigator brochures
- Patient safety narratives
- Patient information
- Informed consent forms
- Patient brochures
- Pharmacovigilance documents
- Periodic safety update reports
- Clinical trial registration and results postings onclinicaltrials.gov
- Data Safety Monitoring Board (DSMB) Charter writing
- Standard operating procedures (SOPs)
- Covering all aspects of drug development including clinical trial design, conduct, and reporting, and the outsourcing of sponsor responsibilities to a clinical research organization (CRO)
Scientific Communications
- Conference materials
- Abstracts
- Poster presentations
- Slide decks
- Manuscripts
- Editorial support
- Journal/conference submission
- Website content
- Both scientific and patient audiences
- Educational material for patients, healthcare professionals, and pharmaceutical industry personnel