Clinical Development Unit

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Clinical trial operations utilizing collaboration

The Clinical Development Unit is the only professional group in the Daiichi Sankyo Group for monitoring. The Daiichi Sankyo Group has gained a great deal of confidence from physicians and medical staff due to its brand power, and it has great promise from patients as well. We wish to deliver our drug discovered by our own group to patients as soon as possible, and we are working together with Daiichi Sankyo to promote drug development.

High-quality and efficient clinical trials

The Clinical Development Unit conducts a wide range of pharmaceutical development for the Daiichi Sankyo Group, from early phase to late phase products. Moreover, as a strength of being a member of the Daiichi Sankyo Group, we are making use of the expertise we have developed at the monitoring from the project planning stage, enabling a precise approach to the challenges and achieving high-quality and efficient clinical trials. Daiichi Sankyo and Daiichi Sankyo RD Novare are working to maximize development efficiencies through the division of roles between management and operations, such as monitoring and QC.

Pharmaceutical Development with a Focus on Oncology

Studies Conducted
(October 2019 / based on the number of studies)

The Clinical Development Unit is promoting state-of-the-art and pivotal trials in the oncology field of Daiichi Sankyo, including antibody-drug complexes (ADCs: Antibody Drug Conjugate). In an age when one in two people will develop cancer during their lifetime, numerous unmet medical needs must still be met.

Development of human resources in oncology and global development

The Clinical Development Unit continues to support the growth of employees by providing new employees with enhanced training, including sedentary new employee and OJT. In addition to new employees, it also provides detailed training based on individual skills. In charge of oncology and global development promoted by Daiichi Sankyo, expert medical knowledge and English language skills are essential. We are dedicated to the development of professional monitors, such as medical training by physicians and English training by native lecturers (medical doctors).

Examples of Training
  • Joint training for all new employees of the Daiichi Sankyo Group (Apr.): training to deepen the understanding of the Daiichi Sankyo Group as a whole
  • Joint training for new employees in the research and development divisions of the Daiichi Sankyo Group (May - June): Training to obtain knowledge and expertise in research and development-related work
  • Junior monitor training through joint project with other companies
  • English training by a native lectures (medical doctor)
  • Medical training by physicians
  • Medical writing training, IT training (e.g. Microsoft Office Word, Excel)

Efforts to improve the clinical trial environment

Digitizing the many documents generated by clinical trials (going paperless) not only enhances efficiency and cuts costs, but also enhances the reliability of information and serves as preparation for the risk of disasters. The Clinical Development Unit collaborates with the Center for Clinical Trials Promotion of Japan Medical Association to promote the introduction of CtDoS2 by medical institutions. Knowledge and expertise gained from this activity will be disseminated externally through the "The Japanese Society of Clinical Pharmacology and Therapeutics" and "The Conference on CRC and Clinical Trials", with the aim of improving the clinical trial environment.

CtDoS2

CtDoS2 is a cloud system provided by the Center for Clinical Trials Promotion of Japan Medical Association for the purpose of creating, submitting, receiving, and storing procedure documents related to clinical trial operations in general.

Examples of external presentations
  • 35th Annual Meeting of the Japanese Society of Clinical Pharmacology and Therapeutics: Examples of the adoption of CtDoS2 by the Daiichi Sankyo Group
  • 16th Conference on CRC and Clinical Trials: Digitization initiatives by Daiichi Sankyo RD Novare
  • 19th Conference on CRC and Clinical Trials: Approaches for Adopting CtDoS2 in Large-Scale Studies

Main Business Activities

Project management

Monitoring

Medical writing

Quality control

Data management

Statistical analysis