Digital Support
At SOUSEIKAI, various types of digital support are available for our sponsor's convenience, as well as for best clinical trial practices.
Digital Supports Available at Our Sites
- Teleconference System
- Online Meeting System
- Remote SDV
- Sponsor-selected EDC System Support
- CDISC Conversion Support
- eSource
One of the recent digital revolutionary solutions in early phase studies can be an e-source system (DDC, direct data capture)
As an industry leader, SOUSEIKAI applied the concept in early healthy volunteer study in 2016 for the first time in Japan, and now we have compiled experience and know-how to accommodate the demands in ever advancing the world.
There have been suggested high interests from the regulatory as well and three of the studies using e-source in Japan have been subject to inspection by the PMDA and completed successfully.
Sponsor's Benefits when Using eSource:
- Increased Data Quality (Ensures Compliance with ALCOA-CCEA)
- Quicker Availability of Data
- Reduced Frequency of Site Visits
- Reduced Trial Operations Costs
- Decreased Study Timelines
Save time. Reduce resources. Cut costs.
Guidance for eSource
Japan Pharmaceutical Manufacturing Association
https://ecompliance.co.jp/english/Guidance%20for%20electronic%20trial%20data%20capturing%20of%20clinical%20trials.pdf
FDA
https://www.fda.gov/downloads/drugs/guidances/ucm328691.pdf
