Integrated Development Associates Co., Ltd. (IDA), established in March 2004, is a Japanese company that provides product development and regulatory consulting combined with full CRO capabilities to prepare and execute development strategies for novel biopharmaceutical products for Japan and Asia. IDA’s unique business model enables companies to increase the value of their products through intelligent product development planning, accelerated clinical trial implementation, and optimal product positioning.
1) MARKET, MEDICAL & REGULATORY STRATEGY
IDA develops market entry strategies by integrating IT-driven market intelligence with cutting edge product development consulting.
- Market Analysis & Medical Strategy- IDA provides expert medical and scientific analysis to identify optimal Japanese product positioning
- Product Development & Regulatory Science- Based on a scientific assessment of compounds, medical analysis of treatment practices and KOL interactions, IDA gains PMDA endorsement of efficient product development strategies
2) COMPREHENSIVE MANAGEMENT OF CLINICAL DEVELOPMENT
Led by a multi-disciplinary team of professionals and backed by cutting edge Information Technology, IDA plans and manages all aspects of clinical development in Japan and Asia.
- Clinical Program Management- IDA designs and implements Pan Asian Phase 1 thru 4 study protocols and, as an In Country Caretaker (ICC), assumes all regulatory and operational responsibilities as well as files J-NDAs as a Marketing Authorization Holder (MAH)
- Clinical Operations- IDA staff provide comprehensive monitoring and site management services that allow for rapid and efficient recruitment and execution of clinical trials of any size or complexity
3) PARTNERING SUPPORT
IDA provides services to support commercialization planning and implementation through identification of and assistance in negotiations with potential licensing partners
As Asia, with Japan at the Center, emerges as the world’s largest pharmaceutical market and as PMDA solidifies a position as a key arbiter of regulatory policy for the region, IDA stands poised to lead the way in bringing Japan and Asia to the center of drug development. By creatively partnering with clients throughout the entirety of the product development and commercialization process, IDA aims to accelerate patient access to new therapies and enhance the value of new products throughout Japan and Asia.