Our medical affairs function is composed of professional medical staff with rich clinical trials experience who are committed to providing customers with high-quality medical services. With extensive clinical, therapeutic and research experience, our medical advisors work closely with principal investigators to provide high-quality medical monitoring and clinical trial protocol design. Maintaining the scientific process, integrity and safety through clinical trial design, implementation, analysis and summary is a primary goal.
Our medical writers have extensive experience in medical writing and provide services in therapeutic areas such as endocrine, cardiovascular, neurology, oncology, orthopedics, urology, hepatitis, hematology and Medical Device & Diagnostic (MDD). Our medical writers also prepare investigator’s brochures, study protocols and clinical study reports (CSRs) – and conduct ICF design and review and medical review for CRFs. Following the ‘’Clinical evaluation guidance for Medical Device& Diagnostic (MDD)” issued in 2015, the Kun Tuo medical team notably became the first to implement Clinical Evaluation Report (CER) writing services in China.
Our medical affairs services
- Clinical trial protocol design (Phase I, II, III, IV and Medical Device & Diagnostic (MDD))
- Investigator’s brochure development
- Patient narrative development and review
- Develop summary of clinical trial dossier
- Medical consulting
- Provide therapeutic area training for CRAs
- Clinical trial protocol and protocol synopsis development and review (Phase I, II, III, IV and Medical Device & Diagnostic (MDD))
- CSR development and review
- Literature retrieval and medical device CER development
- Perform medical monitoring and provide support to project management