Anju has launched a new cloud-based electronic trial master file software product, eTMF Master, for clinical trials.
eTMF Master will aid partnership between sponsors, contract research organisations (CROs) and sites to effectively handle clinical trial content in a regulatory-compliant setting.
To fulfil rising regulatory needs and meet deadlines for agency inspections, sponsor audits and internal audits, the solution permits a quick compilation of clinical trial-sourced digital documents and images.
Furthermore, the system backs the standard Trial Master File (TMF) Reference Model to define trial master file records.
eTMF Master is built on the enterprise content management technology of the company and offers robust search and workflow expertise and facilitates integrations with Anju and third-party eClinical systems.
The cloud-based solution also offers low business risk, improved artifact quality and reduced auditing and reporting expenses to organisations while boosting productivity and team communication.
Data integrity, access controls and regulatory compliance features guarantee that the electronic master file is always ready for audit while artifact quality is enhanced using automated quality control processes and distinct workflows.
By offering quick implementation and configuration, actionable insights and adaptable search expertise, eTMF lowers expenses often linked to manual paper-based and legacy trial record-keeping systems.
Anju Product Management-eTMF director Debashish Niyogi said: “With clinical studies becoming more complex and stakeholders responsible for tracking and reporting rapidly multiplying trial-related content, the industry is asking for more efficient regulatory-compliant processes to create and manage essential trial content.
“As the latest addition to our eClinical suite, we designed eTMF Master so sponsors, CROs and sites working on a clinical trial anywhere in the world can collaborate with each other and quickly collect and manage all their content in one system to help ensure that no information about that trial is ever missing.”