Medical Writing

Our medical writers work closely with our project managers and the lead CRA to prepare documents that meet regulatory requirements on an ongoing basis throughout the entire study process. Our writers’ knowledge of ICH guidelines and clinical study statistics informs the content and format of clinical study reports (CSRs).

We use a two-step process for CSR writing:

1. Produce ICH-compliant CSR shell before the trial is completed so the client can review, edit and approve the format in advance
2. Provide the client the first draft CSR within 4 weeks of database lock

Services include:

• ICH-GCP compliant CSR
• Clinical and preclinical study protocols
• Informed consent forms
• Investigator brochures
• ISS/ISE (integrated summaries of safety and efficacy)
• Manuscripts, abstracts, poster presentations and summaries
• DSMB reports