souseikai global clinical research center

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

EMA
http://www.ema.europa.eu/docs/en_GB/document_library/