After obtaining endorsement of a clear pathway to Japanese approval, IDA comprehensively plans, initiates and manages the implementation of all Japanese and Asian clinical trials necessary for Japanese and Pan Asian product approval.
In most development programs for Japan, Phase 1 clinical trials in Japanese healthy volunteers are required to establish safety and tolerability in a Japanese population as well as PK similarity between Japanese and non-Japanese to enable extrapolation of foreign data to support a Japanese NDA. IDA’s expert team has extensive experience in the design of ethnic bridging study protocols and provides comprehensive trial implementation services for such Phase 1 trials that allow clients to implement Phase 1 trials that will support Japanese regulatory and development objectives. IDA can implement these trials in Japanese volunteers at sites either inside or outside of Japan. IDA has established an exclusive partnership with De La Salle Health Sciences Institute (DLSHSI) in the Philippines for cost-effective implementation of Ex-Japan Phase 1 trials in Japanese healthy volunteers.
The services and capabilities of the IDA-DLSHSI Phase 1 trial collaboration are as follows:
- Protocol design and preparation of non-Japanese comparative PK analysis plan
- Trial implementation
- 40-bed teaching hospital-based Phase 1 unit at DLSHSI
- Extensive experience working with Japanese and other ex-Japan Phase 1 sites
- Local regulatory expertise
- Experienced and bilingual project management and monitoring capabilities
Through offices in Tokyo, Osaka and Manila, IDA can comprehensively manage Japanese and Pan Asian clinical trials including serving as a Clinical Trials In-Country Caretaker (“CT-ICC”) as required by Japanese law.
- Preparation, filing and maintenance of Japanese CTNs and INDs in other Asian countries
- Manage all regulatory interactions on behalf of the Sponsor
- Assumption of all safety/ pharmacovigilance reporting responsibilities
- Bilingual Clinical Project Management comprised of staff with significant global trial experience
- Site identification and selection to ensure rapid patient recruitment leveraging extensive relationships and networks with Japanese KOLs
- Clinical Trial Supply importation and management
- Contracting, site management and monitoring of the clinical trial as the Japanese sponsor
- Pan Asian Phase 2-4 clinical trial feasibility and management
Data Management, Biostatistics and Medical Writing Capabilities
- Statistical analysis and data management planning
- Expert database design
- OmniComm Promasys® for Data Management and EDC
- Experienced English speaking data managers
- Bilingual production of Clinical Study Reports