Integrated Development Associates Co., Ltd. (IDA), founded in 2004 and a member of the M3 Group since March 2015, is a Japanese company that provides consulting, CRO and IT driven solutions that enable the optimal development and commercialization of novel pharmaceutical 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 effective marketing strategies.

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- Combining M3’s unparalleled network of health care professionals  with expert medical and scientific analysis, IDA estimates market potential and identifies 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)
  • CRO & e-Trial Support Services- The M3 Group has approximately 2,000 staff providing comprehensive CRO and SMO services backed by proprietary IT solutions  that allow for rapid and efficient recruitment and execution of clinical trials of any size or complexity

3) COMMERCIALIZATION SUPPORT & PARTNERING

IDA and M3 provide a variety of services to support commercialization planning and implementation. In select cases, IDA and the M3 can also share risk in creative development partnering approaches.

  • Commercial Launch Preparation- IDA supports  expert medical communications enhanced by valuable input gained via M3’s network of health care professionals
  • Medical and Product Communications- Using “MR-kun” M3 provides a 2-way channel for communication with physicians to ensure the full and accurate understanding of product utilization
  • Post-Marketing Trials- Leveraging M3’s large scale clinical trials capabilities IDA and M3 plan and implement trials to generate evidence that enhances post-launch product value


In the past era of FDA/ EMA oriented drug development, IDA pioneered approaches that allowed western biopharmaceutical companies to plan and implement Japanese and Asian drug development fully aligned with US and European strategies. In a new era, as Asia emerges as the world’s largest pharmaceutical market and PMDA solidifies a position as a key arbiter of regulatory policy for the region, IDA and the M3 Group stand 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 and the M3 Group aim to accelerate patient access to new therapies and enhance the value of new products throughout Japan and Asia.

© 2016 IDA Integrated Development Associates.