As a major domestic CRO company, Stemexcel began to run foreign clinical trials a few years ago, and thus deeply realized the difficulty of document management for international multi-center projects.
Regulatory authorities in various countries have different eTMF management demands for international multi-center projects. Executive teams in different countries also have different requirements for the compatibility of eTMF management processes. Blind/non-blind document management requires refined management of eTMF. With DM (clinical data management), PV (pharmacovigilance), ST (statistics) and other factors involved, eTMF management was needed on an even greater level.
With a good eTMF management base already established for domestic projects, Stemexcel had increased the scope of eTMF management’s standard formulation and system construction for international projects. During the construction process, Taimei Technology actively communicated with and supported the Stemexcel team throughout the entire process. The collaborating teams were able to complete the eTMF deployment in the African region in a short period of time and successfully put it online.
Taimei Technology’s eTMF business expert team provided early consultation and diagnosis of eTMF management capabilities. The international implementation team worked with the previous implementation team, formulated implementation plans, communicated effectively, and helped the client quickly establish overseas eTMF management systems.
I. eTMF is based on the CDSIC Reference Model. It determined the required eTMF list based on the project’s characteristics and established an eTMF directory template for international projects.
II. Taimei Technology’s eTMF business experts provided definitions of international eTMF management roles and responsibilities, a QC checklist, and the CDSIC Reference Model to help Stemexcel quickly determine the document management workflow and ensure document quality.
III. eTMF allowed the use of a blind/non-blind independent folder management method to ensure permission isolation and avoid the risk of blindness caused by human errors to the greatest extent.
IV. Since Taimei’s overall system interface is bilingual, eTMF supports both Chinese and English environments. When executing clinical trials abroad, research teams can quickly start using Taimei’s system.
V. Taimei’s team executed a User Acceptance Testing (UAT) Plan to verify that the eTMF management system would meet the needs of the client. The steps included:
Taimei Technology used cloud technology and provided professional customer success services to actively respond to and support the management needs of the Stemexcel team, empower international management, and quickly complete the implementation of international eTMF management within 1 month. Taimei’s international eTMF officially launched in Africa on October 17, 2022. It established an eTMF file storage hub, a file quality management system, and an eTMF management process for Stemexcel to implement projects in various countries.
In support of international projects, Taimei Technology provided comprehensive support based on the rich practical experience of previous expert teams and overseas implementation teams, helping projects avoid potential problems, quickly get online, and successfully respond to Stemexcel’s overseas eTMF construction needs. The successful completion of this project also further enhanced Stemexcel’s trust in Taimei Technology’s team. Stemexcel and Taimei will continue to work together in the eTMF development for the Pakistan and Southeast Asia projects.
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