In-House Clinical Development Capabilities and Use of External Organizations
First written in FY2016. 10 of 12 entries say "Restated". Latest entry: FY2025.
0 other companies' latest entry also says "Restated".
- FY2025RestatedAnnual report
「After licensing in pharmaceutical and other product candidates, the Group forms development teams centered on its in-house clinical development capabilities and external contractors in each region of Asia, including Japan, including Contract Research Organizations (CROs), and plans and conducts clinical trials in those regions, including certain additional nonclinical trials required for marketing approval in the relevant country, or international clinical trials focused on Asia.」
The Group continues to combine its in-house clinical development capabilities with CROs and other external organizations. - FY2022RestatedAnnual report
「After licensing in pharmaceutical and other product candidates, the Group forms development teams centered on its in-house clinical development capabilities and external contractors in each region of Asia, including Japan, including Contract Research Organizations (CROs), and plans and conducts clinical trials in those regions, including certain additional nonclinical trials required for marketing approval in the relevant country, or international clinical trials focused on Asia.」
The Group continues to combine its in-house clinical development capabilities with CROs and other external organizations. - FY2022-Q3RestatedAnnual report
「The Group operates a business centered on clinical development capabilities from the licensing in of development candidates through regulatory approval, as well as functions for dealing with regulatory authorities, including approval applications.」
The Group continues to position itself around clinical development and regulatory affairs after licensing in candidates, rather than basic research, sales or manufacturing. - FY2022-Q2ReframedAnnual report
「The Group operates a business focused on midstream clinical development capabilities and does not have upstream or downstream functions.」
The Group clarified its position in the pharmaceutical value chain as a business focused on clinical development, without upstream or downstream functions, while using its own capabilities and external organizations. - FY2019-Q1RestatedAnnual report
「A2 Healthcare Corporation — Outsourcing of development activities (Note) — 4」
The Group continues to outsource development activities to external organizations while maintaining its own development capabilities as the core. Outsourced transactions totaled ¥4 million for the three-month period ended the first quarter. - FY2018-Q3RestatedAnnual report
「A2 Healthcare Corporation — Outsourcing of development activities (Note) — 79」
The Group continues to outsource development activities to external organizations while maintaining its own development capabilities as the core. Outsourced transactions totaled ¥79 million for the nine-month period ended the third quarter. - FY2018-Q2RestatedAnnual report
「A2 Healthcare Corporation — Outsourcing of development activities (Note) — 52」
The Group continues to outsource development activities to external organizations while maintaining its own development capabilities as the core. Outsourced transactions totaled ¥52 million for the six-month period ended the second quarter. - FY2018-Q1RestatedAnnual report
「A2 Healthcare Corporation — Outsourcing of development activities (Note) — ¥26 million」
The Group continues to outsource development activities to external organizations while maintaining its own development capabilities as the core. - FY2017RestatedAnnual report
「The Group’s development division performs core functions including clinical development planning, trial design, operations and evaluation, as well as regulatory affairs related to the development of pharmaceuticals and other products. In conducting trials, it uses external contractors, including contract research organizations, to improve operating efficiency and reduce fixed costs.」
The Group continues to center its development structure on in-house capabilities while using CROs and other external organizations. - FY2017-Q3RestatedAnnual report
「A2 Healthcare Corporation — Outsourcing of development activities (Note) — ¥97.147 million」
The established development structure, in which development activities are outsourced, continues. - FY2017-Q1RestatedAnnual report
「Outsourcing of development activities」
Development activities continue to be outsourced to A2 Healthcare Corporation, a subsidiary of an affiliate, confirming the continuing use of external organizations in the development structure. - FY2016First statedAnnual report
「After licensing in pharmaceutical and other product candidates, the Group forms development teams centered on its in-house clinical development capabilities and external contractors, including contract research organizations, in each region of Asia, including Japan, and plans and conducts clinical trials in those regions or international clinical trials focused on Asia.」
The Group uses CROs and other external organizations while relying on a small core of specialized employees to operate clinical trials and control fixed costs.