Clinical Development Unit

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Clinical Trial Operations Leveraging Collaboration

The Clinical Development Unit is the only group of professionals involved in monitoring in the Daiichi Sankyo Group.The brand power of the Daiichi Sankyo Group has earned the deep trust of doctors and medical staff, and we have received great expectations from patients. We are working together with Daiichi Sankyo to promote the development of pharmaceuticals with the desire to deliver the drugs we have created in our own group to patients as soon as possible.

Conducting high-quality and efficient clinical trials

The Clinical Development Unit involves in a wide range of trials from early phase to late phase for pharmaceuticals of the Daiichi Sankyo Group. In addition, as a strength of being a member of the Daiichi Sankyo Group, by utilizing the know-how cultivated at monitoring sites from the planning stage of the project, we are able to make an accurate approach to challenges and realize high-quality and efficient clinical trials. We maximize development efficiency by dividing the roles of overall management in Daiichi Sankyo and operations such as monitoring and QC in Daiichi Sankyo RD Novare.

Promoting Pharmaceutical Development Centered on the Oncology Area

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.

Fostering human resources to play a leading role in oncology and global development

The Clinical Development Unit provides new employees with extensive training centered on classes and on-the-job training. In addition to new recruits, the unit also provides detailed training tailored to individual skills. Through these and other measures, the unit provides ongoing support for employee growth. Specialized medical knowledge and English ability are indispensable to be in charge of the oncology field and global development promoted in Daiichi Sankyo. We are focusing on fostering professional monitors by conducting medical training by doctors and English training by native lecturers (doctors of medicine).

Examples of Training
  • Joint training for all new employees of the Daiichi Sankyo Group (April): Training to deepen understanding of the entire Daiichi Sankyo Group
  • Joint training for new employees belonging to the R&D department of the Daiichi Sankyo Group (May to June): Training to acquire knowledge and know-how of R&D-related operations
  • Young monitor training through joint planning 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)

Initiatives aimed at improving the clinical trial environment

Not only will it be possible to improve efficiency and reduce costs by making documents generated in numerous clinical trials (paperless), it will also improve the reliability of information and prepare for disasters and other risks. The Clinical Development Unit is working with JMACCT (Center of Clinical Trials, Japan Medical Association) to promote the introduction of CtDoS2 (Cut Do Square) to medical institutions. The knowledge and know-how gained from these activities are disseminated externally through "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.

What is CtDoS2?

CtDoS2 is a cloud system provided by JMACCT(Center of Clinical Trials, Japan Medical Association) for the purpose of preparing, receiving, and storing procedural documents related to general clinical trial operations.

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