Why PAREXEL is the Write Choice
Its importance underestimated and its execution often spotty, the development and submission of medical writing in the context of clinical research nevertheless plays a critical role in the success or failure of new compounds and devices. Regulators search intensively for errors and inaccuracies, as well as the precise documentation and reporting they require. Delays in this stage lead directly to delays in realizing revenue.
The Medical Writing Services group at PAREXEL is uniquely qualified to help you compile, organize, write, edit, and produce a wide range of medical and scientific documentation required to support your product development efforts. We offer fast turnaround and a flexible, efficient process for any project large or small, including:
- Clinical development plans
- Protocols
- Clinical study reports
- Clinical sections of Common Technical Documents (CTDs)
- Clinical sections of New Drug Applications (NDAs)
- Abstracts, manuscripts, and journal articles
- Investigator brochures and annual updates
- Informed consent forms
- Periodic Safety Update reports (PSURs) and other pharmacovigilance documents
- Pre-FDA meeting briefing documents
- Response to clinical hold orders
- Preclinical study reports, expert reports, and summaries
- Data Safety Monitoring Board (DSMB) manuals
- Written and tabular summaries
- Benefit/risk assessment reports
- Medical and scientific literature reviews
PAREXEL has handled thousands of writing projects in more than 29 countries in North and South America, Europe, Asia, and Africa. Unlike most writing services that rely on freelance writers, PAREXEL employs a large, full-time staff of experienced medical writers who have extensive backgrounds in most therapeutic areas. Many possess master’s and doctorate degrees; in addition, thanks to our global presence we are able to provide writers who work in a number of different languages.
To discuss your medical writing and submission requirements, contact the the medical writing staff.
