Our medical writers deliver the high-quality, accurate documents that are essential to a successful clinical research program.

 

Our global team of medical writers has extensive experience in all forms of regulatory writing across the development life cycle. Each member of our core team has more than 15 years of experience in creating EMA and FDA-compliant documents, always ensuring they are up to date on current recommendations and new practices.

We know that clarity, accuracy and quality are paramount, and our experience, history, and knowledge mean we can deliver quality documents in the shortest possible time. In fact, because our team is spread around the globe, we can offer a 24-hour service, shortening timelines.

Our medical writing team also has formidable experience in pediatric studies; combined with Ergomed’s patient-centric approach, our child-facing documents are user-friendly and as clear as possible. The teamwork in collaboration with colleagues across Ergomed – including regulatory, biostatistics, and medical, project and data management teams – to ensure projects are efficient and seamless.

Regulatory Medical Writing

Our medical writing services span the full development cycle and the full spectrum of regulatory documentation from clinical to non-interventional and real-world evidence areas. This includes writing/updating:

  • Clinical study reports
  • Protocols
  • Investigator brochures
  • Investigational new drug dossiers (IND)
  • Investigational medicinal product dossiers (IMPD)
  • Converting INDs to IMPDs
  • Informed consent forms
  • Child assent forms
  • Briefing books
  • Integrated summaries of safety/efficacy (ISS/ISE)

Stand-Alone Medical Writing

Our medical writers have broad experience of completing partial documents, writing new documents from scratch, and when needed, working with external teams. The stand-alone medical writing services include:

  • Advice on the structure of documents
  • Study design
  • Completion of documents
  • Protocols, informed consent forms, investigator brochures
  • Protocol synopsis work for investigational new drugs
  • Clinical study reports
  • Updating SmPC
  • Literature reviews.