Introduction
Our medical writers work closely with Sponsors, Statisticians
and Medical Advisers in order to develop study protocols,
clinical investigation plans and study reports in accordance
with current regulations and guidelines.
The Medical
Writers collaborate with the project team, and participate
interactively throughout the study, from protocol to final
study report.
Services
Poseidon CRO offers medical writing as part of a full-service program or as a stand-alone service. Our medical writing team supports preparation of the following:
- Protocol Design for Phase I-IV clinical studies and Post Marketing Observational Studies
- Informed consent form design
- Case Report Form Design
- Study specific questionnaire design
- Written and tabular summaries
- Medical and scientific literature reviews
- Literature Search & metananalysis services
- Periodic Safety Update reports (PSURs) and other pharmacovigilance documents
- Expert reports and executive summaries
- Data Safety Monitoring Board (DSMB) manuals
- Interim/Final study report preparation
- Clinical study reports