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Medical Affairs

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 strengths

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
Medical Affairs