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.