“Our search for an eTMF solution required that we find a product that met DIA requirements and was designed and backed by people who truly understand the world of clinical trials. The claims made by the Trial Interactive team during our evaluation process were proven overwhelmingly true; it’s...
The Electronic Trial Master File is recommended to ideally be a document management system containing all the necessary controls. Adoption of electronic document management processes is becoming essential to business productivity, cost savings and shortened BioPharma product development timelines.Raju Sama...
“The software (pharmaREADY) has been an excellent investment for our company’s FDA electronic filings. We found working with Navitas a pleasure from installation and validation through ongoing support. We will fully realize return on our investment with their user-friendly product, ongoing support,...
eArchives is a secure cloud-based application designed for the life science and pharmaceutical industries. It supports the DIA reference model and complies with GCP regulations, covering all stages of clinical trial documents.
Extract data for analysis and reporting and much more! Getting Started System requirements Report an issue Release notes Extensions/Contributions Installation To request a feature please submit a ticket onJiraor start a discussion on theOpenClinica Forum. ##Screenshots##...
MasterControl software is FDA 21 CFR Part 11 compliant and supports various requirements, such as FDA regulations, ISO requirements, CLIA, EU MDR, and more. The software automates GAMP 5 processes and offers a patented Validation Excellence Tool (VxT) for user-friendly software validation. ...
Well-structured scientific data can be more easily transferred to an eLN, and even changes in the eLN system will not have a devastating effect on original file organization. Based on the requirements for data documentation, we suggest the following steps to a better data documentation policy that...
ArisGlobal Announces Cloud-based Electronic Trial Master File (eTMF) Solution to Better Meet GCP Regulatory Requirements and Reduce Time to SubmissionCompany Press Release
EMC Documentum Electronic Trial Master File SolutionEMC Corporation
Archive folder for Trial Master File (TMF) support Generation of FDA-compliant PDF packages containing event history GCP-compliant audit trail for transparency and compliance Self-training module for each profile to simplify users’ daily work and to minimize the risk of delays, omissions, and error...