Rho's medical writing professionals consistently produce clear, concise, and accurate documentation in support of clinical trials research. Rho has substantial experience authoring reports in accordance with ICH Guidelines and creating clinical trial and regulatory documentation suitable for submission to the FDA.

Rho's seasoned medical writers draw on extensive industry knowledge and therapeutic expertise to effectively meet the requirements of each project. Their expertise is enriched through study-specific training at project commencement and continuing education. All of Rho's medical writers possess a postgraduate degree. The medical writing group at Rho has experience in a wide range of therapeutic areas, including, but not limited to:

Cardiovascular Circulatory CNS Dermatology Endocrinology

Gastrointestinal Immunology Pain Management Reproductive Respiratory

As part of a full-service CRO, the Medical Writing Department has instant access to experts in every stage of clinical development. Multiple QA checks help ensure that deliverables meet both Rho's and the Sponsor's high quality standards.

Rho's medical writing services include:

Protocol templates Clinical trial protocols and amendments Investigator brochures Study procedure manuals DSMB reports Interim data summaries Safety narratives

Clinical study reports Journal articles Integrated Summaries of Safety (ISS) Integrated Summaries of Efficacy (ISE) Investigational New Drug Applications IND annual updates SOPs and working practice documents

Whatever your needs, Rho's medical writing group will support your drug development initiatives with clear, precise medical documentation. As an integral member of your clinical development team, Rho's medical writers will meet aggressive deadlines and provide the highest quality deliverables.