Electronic Document Management Suite
The Management of Clinical Research Document Is Very Important
The trial master file (TMF) is a collection of all relevant paper or electronic documents produced in a clinical study. As a retrospective evidence, a complete clinical research document should be able to fully reproduce the whole process of clinical research, the existence of which can prove the authenticity and compliance of clinical research. Therefore, the standardization of document management directly affects the science, authenticity, accuracy and reliability of clinical research, as well as reflects the professionalism of the research team.
Practical Problems and Challenges in the Management of Clinical Research Documents
Confronted with a large number of clinical research documents, there are several inevitable practical problems in the operation process: unimplemented standard process, insufficiency of professionals and the ignorance of professional system functions will seriously affect the completeness, timeliness and accuracy of document collection.
Taimei Medical Technology Clinical Research Document Management Solutions
Will help you:
Establish a document management plan
Create and manage eTMF document
Receive and archive the original documents
Review electronic document and track problems
Store and deliver documents
eArchives® Standard Execution:
Project document management process
Electronic document upload and storage
Timely tracking document problems and handling
Electronic document review
Document storage and download
eArchives® | Electronic document management system to ensure complete, timely and accurate clinical research documents
eArchives is a professional electronic document management system jointly developed by top medical experts and computer engineers according to the actual flow of clinical research. The system design strictly follows the GCP industry standard and 21CFR PART11 requirements.
eArchives can make document management more secure and compliant, effectively improving the efficiency and quality of clinical research.
Abandon the traditional document management model and enter the eArchives era
Intelligent document tracking: document planning, file upload reminder
Comprehensive inspection traces: file additions, deletions and changes are traceable
Rich template library resources: standard TMF model, SOP template, document planning library
Flexible and robust architecture: easy to function expansion and smooth version upgrade
International cryptography encryption: ensuring sound and secure customer privacy
Self-defined approval process: according to different SOP requirements for each company
Query reminder and handling: query raise at any time, query reminder, batch processing
Multi-system interconnectivity: data sharing with systems such as AIMS and eCollect of Taimei Medical Technology to avoid data inconsistency and duplicate entry