Case Study: Taimei quickly establishes eTMF management standards for Stemexcel’s international projects

Background

From domestic to overseas projects, Chinese CRO companies are entering a new era of global competition, which has also raised requirements for the digital capabilities of domestic CRO companies. In terms of clinical research document management, Taimei Technology's platform has become a trusted solution for many overseas projects.
 
Beijing Stemexcel Technology Co., Ltd. (Stemexcel) is an international contract research organization. Since its establishment in March 2005, in order to meet the growing demand for clinical research services, Stemexcel has provided a full range of services to domestic and foreign customers. It is headquartered in Beijing and has representative offices in the United States and South Korea.
 
In 2022, Stemexcel Overseas worked with Taimei Technology with the objective that both the documents for overseas projects and domestic documents could be stored and managed by Taimei Technology’s eTMF platform, eArchives to form the international eTMF management standard for Stemexcel’s overseas projects.

Challenge

Quickly Establish International Project Document Management Standards for a CRO Working Overseas

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.

Solution

Provide Electronic Document Management Solutions Based on eArchives

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:

  1. Building the UAT environment
  2. Confirming UAT participants
  3. Writing the UAT script
  4. Having test users follow the script to perform UAT
  5. Tracking and resolving UAT problems to ensure that the system quickly enters a stable period of operation after it goes online.

Results

Provide Comprehensive International Project Support to Achieve Rapid Deployment and Launch of eTMF

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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