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
Among the above, the first time eSource was implemented in Japan was at SOUSEIKAI’s sites. Currently, three studies utilizing eSource have successfully completed PMDA’s inspections in Japan.
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
