Medical Writing for Clinical Trials
PPD ensures your clinical trial documents are clear, concise, fully compliant with regulatory requirements, and scientifically and medically accurate.
Comprehensive Medical Writing Services
Medical writing services are available as an integral part of a full drug development program, a Phase I-IV clinical trial or as a stand-alone service. Our medical writing team supports preparation of all regulatory documents, including:
- Phase I-IV protocols
- Phase I-IV integrated clinical statistical reports (ICSR)
- Global clinical trial applications
- Drug, device and biologic marketing applications
- Preclinical and scientific reports
- Investigator brochures
- Premarketing and post-approval annual reports
- Patient safety narratives
- FDA briefing documents
- Risk management plans
- Pediatric investigational plans
Our Phase I-IV integrated clinical statistical reports include carefully compiled appendices and scientifically accurate text written to be compliant with all applicable ICH guidelines. Working within strict standards of quality, PPD puts all of its documents through a continuous, in-process quality control review to guarantee compliance with regulatory requirements. In addition, the documents go through a careful scientific and medical review.
Report Publishing Services
PPD strives to provide clients with reports that can be dropped straight into their mission-critical submissions. We publish to client specifications or internal PPD standards. Reports can be provided in several electronic or paper formats and any combination of formats to suit your needs.
Our medical writing quality control processes ensure published outputs are compliant and maintain consistency with your overall submission.
Study reports can be:
- Consolidated into a single file from a variety of file formats
- Published to the ICH Study Tagging File format, including study XML files
- Published electronically to include hyperlinked tables of contents, PDF bookmarks that match the table of contents and PDF hyperlinks on all internal cross-references
- Published to volume level postscript files compatible with high-speed printers capable of automated tab printing and insertion
PPD also provides medical writing and editorial services to communicate drug information to health care professionals and consumer audiences.
