PAREXEL’s Medical Writing Services team is one of the largest and most experienced in the biopharmaceutical industry, providing a wide range of high-quality documents from Phase I through to post-marketing and beyond. Read more.
View 4 related solutions for
Medical Writing & Submission
Why PAREXEL® is the Right 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 for 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
- 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 managed 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 contributors, 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 can provide writers who work in a number of different languages.
To discuss your medical writing and submission requirements, please contact our medical writing staff.
Early Phase Services
More of What You Need for a Stronger Start in Phase I. Your journey from new molecule to new medicine starts with appropriate subjects, world class facilities, and more timely results. PAREXEL® provides comprehensive early phase testing services through our own hospital-based clinical units on three continents.
Regulatory Information Management
Regulatory Information Management (RIM) is defined as the effective and efficient collection, storage, retrieval and communication of regulatory information. RIM processes include defining product authorization targets, managing regulatory submission plans, creating and gathering submission information, producing and submitting the submission output and managing the product registration.
Late-Stage Clinical Operations
Market Access Consulting
In this post-blockbuster era, traditional opportunities for sustained growth throughout your products’ long-term journey are limited. Biologics, biomarkers, genomics, personalized medicine, and proteomics offer promising alternatives, but commercial dynamics of the biopharmaceutical industry are uncertain.