Clinical Writing
Source: Theorem Clinical Research
Our experienced Clinical Writing professionals are committed to working with you—in accordance with US/EU/ICH guidelines and regulations—to deliver a wide range of high-quality clinical materials on time and in your style/format.
Our experienced Clinical Writing professionals are committed to working with you—in accordance with US/EU/ICH guidelines and regulations—to deliver a wide range of high-quality clinical materials on time and in your style/format. And we understand the importance of communicating the details clearly, concisely, and accurately.
Your success results from our proven Clinical Writing structure and philosophy:
- Diversity. Clinical Writing team members have diverse educational and professional backgrounds, with qualifications in medicine, pharmacy, nursing or life sciences and previous experience in pre-clinical research, clinical laboratory, study coordination, regulatory affairs, and data management.
- Comprehensive Services
- Investigator Brochures
- Clinical Study Reports (CSRs)
- New Drug Applications including Common Technical Document (CTD) Summaries and Overviews
- Literature Reviews
- Clinical Expert Reports
- Executive Summaries
- Journal Manuscripts and Abstracts
- Flexibility. Our document preparation process involves experts from Biometrics, Regulatory, and Medical Affairs who are readily accessible for review and feedback and proactively provide solutions.
- Communication. As we draft the report, we are in close contact with our other cross-functional areas. We also maintain strong communication with you to ensure your first draft is consistent with your expectations.
- Quality. We have internal quality control reviews at each developmental step to ensure accuracy and consistency. Additionally, senior management plays an active role throughout the review process.
This website uses cookies to ensure you get the best experience on our website. Learn more