The quality of written clinical presentations can play a critical role in the success or failure of new compounds and devices.
The medical writing service of INNOPHARMA is qualified to help you in compiling, organizing, writing, editing and producing a wide range of medical or scientific documentation required to support your product development efforts. Below are brief descriptions of some of the clinical documents we are experienced in preparing.
Clinical Development Plans
INNOPHARMA medical writers, in collaboration with our medical and regulatory team members, design and prepare clinical plans that define the product strategy from Phase one through regulatory approval.
INNOPHARMA medical writers work with the medical, statistical, and regulatory team members to design and prepare clinical protocols, whether those team members are client based or part of the INNOPHARMA team.
Clinical Study Reports (Phase I – IV)
INNOPHARMA medical writing service prepare Integrated Clinical Study Reports using relevant information from the study protocol, statistical tables and listings, the Investigator’s Brochure, regulatory guidelines, pertinent literature, medical monitoring reports, and selected patient case report forms. INNOPHARMA medical writing service can compile the report appendices. The report also includes patient narratives for deaths, other serious adverse experiences, and for those patients who discontinued due to adverse experiences.
Clinical Sections of Common Technical Document (CTD)
INNOPHARMA medical writing services can prepare clinical and non-clinical sections of the CTD, i.e., Clinical Overview, Clinical Summary, Non-Clinical Overview and Non-Clinical Summary.
Abstracts, manuscripts, and journal articles
INNOPHARMA medical writers provide abstract and manuscript writing services both as stand-alone projects or as part of a full service offering.
Other documents and services available from INNOPHARMA Medical Writing Services
- Investigator Brochure
- Informed Consent
- Periodic safety update reports (PSURs) and other pharmacovigilance documents
- Preclinical study reports, expert reports and summaries
- Written and tabular summaries
- Medical and scientific literature reviews
- Certified Medical Translation Services