Medical Writing

A clinical study is only one piece of the development puzzle. It is also critical that the study results be organized and presented in a clear, concise manner. In many cases, the quality of this presentation can make the difference in whether a drug ultimately obtains approval.

Over the years, Ora's Medical Writing team has been asked to review over 20 new drug applications (NDAs) for proper positioning, and has often been asked to write entire portions of these NDA filings. Our deep experience working on regulatory documents and interfacing with clinical groups enables us to deliver the best possible NDA documents to our clients.

Ora's medical writers are highly accomplished in a wide array of regulatory document preparation, including investigational new drug applications (INDs), protocols, clinical study reports (CSRs), and new drug applications (NDAs) developed from statistical analysis plans.

In addition to regulatory writing, Ora funds internal educational writing in multiple trade journals and peer review journals to heighten industry awareness of key issues and growing trends.

For more information about Ora's Medical Writing services, please contact Joshua Moriarty, Manager of Medical Communications, at (978) 685-8900, ext. 9433 or jmoriarty@oraclinical.com.