Each member of our core medical writing team draws on extensive industry knowledge and therapeutic expertise to effectively meet our clients' requirements.
Each member of our core medical writing team draws on extensive industry knowledge and therapeutic expertise to effectively meet our clients' requirements. Each writer is a graduate-level life science scholar, and some even hold faculty appointments at local universities. They enhance their scientific and technical expertise through continuing medical education and study-specific training. Our writers also have access to internal therapeutic experts, researchers, and academics to gain a very sophisticated and in-depth insight across many clinical specialties. Their experience and training enable them to expertly prepare reports in accordance with ICH Guidelines and to create clinical trial and regulatory documentation suitable for submission to the FDA and other regulatory agencies.
Rho Medical Writers work collaboratively with Rho experts in regulatory affairs, biostatistics, clinical data management, and other departments to produce clinical writing deliverables that reflect the clinical experience and integrity of the entire organization.
Our vast experience level helps us deliver a portfolio of medical writing services to address the needs of every clinical research project including:
- Drug development plans
- Investigator brochures
- Protocols and amendments
- Informed consents and assents
- Investigational new drug applications
- FDA pre-meeting packages
- Clinical study reports (Phase I, II, III, and IV)
- Safety narratives
- Data and safety monitoring board (DSMB) reports
- Interim data summaries
- Common Technical Document (CTD) sections
- Abstracts and manuscripts
- Integrated summaries of safety (ISSs)
- Integrated summaries of efficacy (ISEs)
The medical writing group at Rho has experience with a wide range of therapeutic areas including:
- Cardiovascular diseases
- Dental/Oral diseases
- Endocrinology/Metabolic disorders
- Infectious diseases
- Nutrition and growth
- Pain and anesthesia
- Reproductive disorders
- Respiratory diseases
Rho's internal quality control (QC) process provides critical guidance to the medical writing department. Our medical writers incorporate a thorough QC function into the document preparation process and complete review and QC cycles for each interim deliverable Rho produces.