Clinical Development Advisory
Clinical development in Japan is nuanced and stringent in its requirements. Navigating those regulatory pathways demands robust support from a Clinical Development Advisory team that’s done it before.
By engaging with IDEC, you access our Japanese regulatory, quality, and compliance expertise through a roster of professionals dedicated to your pharmaceutical or medical device product’s success. Here’s how we do it.
Clinical Development Advisory backed by comprehensive expertise
Once we’ve established a development planning strategy and worked with the PMDA to build our regulatory consultation approach, we have everything we need to support and advise your clinical development program.
Our virtual team will ensure you’ve created a strong clinical trial protocol, you’re prepared for clinical analyses, and you’ve selected and are ready to work with relevant and qualified CROs.
A rigorous approach to Clinical Development Support
As part of the Clinical Development Support process, we’ll be involved with your team across a range of complex processes, from start to finish. Those processes may include:
- The evaluation and selection of CROs.
- Clinical Trial Protocol creation and revision advisory.
- The preparation or revision of investigation drug summaries.
- Analysis planning.
- PMDA inquiry response.
- 30-day survey notification response.
- The XML file creation for and management of clinical trial change notification.
- Response to CRO inquiries.
- Clinical study reporting.
Clinical development demands a team with the expertise and access only IDEC can provide.
Connect with us to begin.
