Medical communication is one of many critical factors that support the regulatory success of a product. Our dedicated medical-writing department comprises experienced professionals who expertly and precisely interpret biostatistics. All are members of the American Medical Writers Association.
Global services range from preparation of individual documents (eg, submission-ready regulatory reports, Investigational New Drug [IND] Applications, pre-IND briefing packages for meetings with the FDA) to extensive medical-writing programs (eg, from protocol to clinical study report to journal publication). Consistent with our therapeutic focus, each medical writer assigned to a project team has the therapeutic expertise necessary to deliver high-quality written material.
Worldwide Clinical Trials Medical Writing services include:
- Development of clinical regulatory submission documents such as (not limited to):
- Protocol Synopsis
- Investigator’s Brochure
- Informed Consent Form
- Clinical Study Report
- Patient narratives
- Clinical and non-Clinical Summaries
- Management of IND submission
- Document Coordination including publishing for eCTD compliance