BizNET-CTM is a clinical trial management software platform designed to support the entire lifecycle of clinical research studies. It provides an integrated suite of solutions for planning, managing, designing, executing, monitoring, and analyzing trial-related activities and data. The platform is intended for use by contract research organizations (CROs), as well as pharmaceutical, biotech, and medical device industries, offering tools that address the needs of clinical research projects from start-up through submission.
The platform features modules for project management, feasibility assessment, volunteer or patient enrollment using iris recognition technology, clinical trial data capture, multi-level review processes, data compilation, and data archiving. It supports electronic case record forms (eCRF), electronic data capture (EDC), clinical data management (CDM), electronic patient reported outcomes (ePRO), clinical laboratory management, sample inventory management, and diagnostic imaging software. BizNET-CTM includes capabilities for randomization, investigational product supply management, and maintains compliance with regulatory requirements such as 21 CFR Part 11, Annex 11, and GCP guidelines. The system is designed to manage documents, tasks, relationships, audits, and training throughout the course of a clinical trial, with features that allow for document version control and adherence to CDISC SDTM data standards.
The platform is available as a cloud-based solution and is described as secure and low-maintenance. It offers an in-built template repository for study and protocol design, supports validation checks, and provides intuitive CRF design tools. Users can generate, manage, clean, and validate clinical data with audit trails, and export data to Excel, PDF, or SAS formats for statistical analysis. The system enables real-time data access for research professionals, making it possible to track and manage studies at every stage.
BizNET-CTM is positioned as a comprehensive solution for all phases of clinical trials, including early phase, late phase, oncology, registry, and post-approval studies. It aims to streamline processes, increase reuse of information, and simplify the execution of clinical trial tasks while ensuring regulatory compliance and transparency for sponsors and regulatory bodies.
In the Project management space, Platform takes a focused approach. It focuses on streamlining the planning, management, and analysis of clinical research trials for CROs and research teams. Platform is a B2B product aimed at clinical research organizations. It runs on the web and the command line.
Sarjen Systems Pvt. Ltd. builds and maintains Platform. Among its 4 catalogued features are trial planning, trial management, and data analysis.
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