Medical Writing

Our medical writing team applies innovative technology, therapeutic expertise and a commitment to quality to ensure clear, concise, and scientifically and medically accurate documents that are fully compliant with regulatory requirements. Our 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. Each project begins with an exacting clinical protocol and ends with an integrated clinical and statistical report and/or manuscript for publication.

We provide an experienced, dedicated writing team with:

• A willingness to embrace creative solutions to challenging projects
• The ability to function within client specifications to match any standard or directive
• The tools and skills to provide electronic publishing services
• An optimum communication process utilizing the latest technologies to keep clients informed of a document’s status at all stages of production

PPD also provides writing and editorial services to communicate drug information to health care professionals and consumer audiences.

Fully Accurate and Compliant Documents

With an unrelenting standard of quality, PPD subjects all of its documents to a continuous, in-process quality control review to guarantee compliance with style guides and regulatory guidelines. Your regulatory submission documents will be characterized by the following:

• Clear, concise, scientifically and medically accurate information
• Full compliance with all applicable International Conference on Harmonisation (ICH) and regulatory requirements

Comprehensive Services

We provide medical and technical writing 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:

• Global clinical trial applications:
• Clinical trial applications (CTA)
• Investigational new drug (IND)
• Investigational device exemptions (IDE)
• Clinical trial notification (CTN)
• Marketing applications:
• New drug applications (NDA)
• Biologic license applications (BLA)
• Marketing authorization applications (MAA) in common technical document (CTD) format
• Pre-market approval applications (PMA)
• Medical device applications - 510(k)
• Preclinical and scientific reports
• Investigator brochures
• Premarketing and post-approval annual reports
• Phase I–IV protocols and integrated clinical statistical reports (ICSR)

Electronic Publishing

We use our expertise in Adobe® Acrobat® to develop an efficient, automatic and nearly seamless methodology for moving documents from word processing software into portable document format (PDF). The resulting user-friendly, submission-ready PDF files:

• Automatically maintain cross-document references such as hyperlinks, bookmarks and indexing, minimizing time needed to prepare electronic documents
• Include final documents features designed to facilitate regulatory review of the electronic submission, such as hyperlinks created between tables and their associated patient listings and between tables/listings and the specifications used to create the table/listing
• Undergo quality control processes, such as checking of hyperlink destinations both on paper and electronically, to assure quality outputs