Medical Writing
As an international, full-service clinical contract research organization, SynteractHCR strives to deliver actionable results for your clinical trial needs. Our medical writing group consists of qualified Ph.D., M.D., and other experts, and our European medical writers are all members of the European Medical Writers Association. Our translation team consists of native speakers with many years of experience in translating all documents necessary for the performance of clinical studies. Our medical writers are committed to delivering a well-designed clinical program that will meet your study’s ultimate goals.
Whether it’s a first clinical protocol, a pivotal trial protocol or the associated documents such as the ICF, the investigator’s brochure, or a full IND/IDE, SynteractHCR’s team brings the therapeutic, clinical, regulatory, and writing expertise needed to ensure the success of your clinical trial from beginning to end, design phase to final regulatory submission.
As a part of our full menu of CRO services, we can provide you with robust and reliable medical writing support at study (or program) completion designed to fit your specific project needs. Whether it is preparing the clinical study report for one study, the ISS/ISE for multiple studies, or the NDA/sNDA, MAA, PMA,or 510K, our experts can help expedite the submission and approval process. Services can be contracted independently.
Medical writers at SynteractHCR have extensive experience in all aspects of the clinical writing process, including scientific manuscripts for peer-reviewed journals, translation of regulatory documents, and IMP dossiers. Our staff strives to strike a balance between medical and marketing components when generating expert reports, posters and other related clinical development and clinical trial operations documents.
Medical Writing Services Include:
- Protocol / informed consent development
- Investigators brochure development
- SOP development
- IMP dossiers
- Clinical study reports according to ICH E3 and eCTD format
- Clinical study protocols and amendments
- Subject information sheets and consent forms, including local language ICFs (prepared and reviewed by the relevant country)
- Abstracts, manuscripts, and posters
- Regulatory applications and submissions
- ISS/ISE
- Case narratives
- Scientific publications for peer-reviewed journals
- NDA/sNDA , MAA, PMA, 510(k) preparation and submission
- Translations of regulatory documents