Products

Cloudbyz eTMF provides a user-friendly solution that simplifies the complex process of access, retention, and retrieval of clinical trial documents, while ensuring that compliance requirements are fully met.

LifeSphere eTMF is an advanced electronic Trial Master File system designed to enhance collaboration and efficiency in clinical research. By supporting the TMF Reference Model standard document types and the eTMF Exchange Mechanism Standard, it enables seamless, real-time file sharing among sponsors, CROs, and clinical sites. This ensures that all stakeholders can contribute to the Trial Master File as a single source of truth, leading to higher quality, more complete, and timely documentation.

Octalsoft's Electronic Trial Master File system is a comprehensive solution designed to electronically capture, organize, share, and store essential documents, images, and artifacts generated throughout the lifecycle of regulated clinical trials. By implementing a recognized taxonomy and structure, the eTMF system ensures efficient content management with built-in checklists and milestone tracking features. Key Features and Functionality: - Configurable TMF: A flexible, wizard-driven process

IQVIA eTMF is an advanced electronic Trial Master File solution designed to streamline the management of clinical trial documents. By integrating precision planning with intelligent automation, it ensures that trial master files are consistently inspection-ready, thereby enhancing compliance and operational efficiency. The platform's intuitive design minimizes manual efforts, reduces risks, and provides real-time insights into document quality, timeliness, and completeness. This empowers clinica

Our electronic Trial Master File (eTMF) simplifies today’s over-engineered products and implementations by empowering oversight without busting the budget. ClinicalHawk eTMF software is one of its kind for managing documents in real-time as the TMF is generated to ensure a constant state of inspection readiness, increase visibility oversight, and improve collaboration.

Clinion eTMF Help teams manage clinical trial documents in a structured way, with real-time tracking and consistent oversight. It reduces the need for manual follow-ups and keeps documentation aligned with study requirements throughout the trial. What can you expect? ● Defined TMF Structure Set up file plans using standard or custom structures across study, country, and site levels. ● Real-Time Tracking of Documents Track expected documents and identify missing or delayed files as the st

Electronic Trial Master File for compliant document storage, workflows, and inspection readiness. • Templates, versioning, electronic signatures, and role-based access. • QC workflows and audit trails aligned with GxP and 21 CFR Part 11 requirements.

DataHub will let you truly serve your customers.

We are a Software Development Company specialized in developing and implementing robust technology solutions for Life Sciences R&D. We help Pharma, Biotech and CROs in reducing their time and cost in Clinical trials by implementing innovative technologies that involves Data warehousing, Analytics, Collaboration, Automation, and Artificial Intelligence. We are committed towards delivering the most efficient and practical end-to-end solutions with HIPAA, GXP, CSV, 21 CFR Part 11 and other app

Kingland is a cloud-ready, text analytics for enterprise data management that includes service bus, search, caching, queuing, notifications, workflow, rules, and access management services. Kingland enables organizations to jump-start enterprise data management projects, helping organizations complete complex, data-intensive projects within six to 12 months.

Montrium recognizes that the TMF holds a significant wealth of information which is of strategic importance for the successful conduct and reporting of clinical trials. Using in-depth knowledge of clinical processes and the TMF Reference Model, the eTMF Connect software tool has been designed for users like you working at the heart of the clinical trial

Aurea Compliance Manager delivers end-to-end integrated solutions designed to address the specific workflow and compliance needs in the Life Sciences.

Trial Interactive provides a practical, author-to-archive approach for streamlining clinical operations, reducing risk, and expediting time-to-market. Clinical professionals around the world consistently choose Trial Interactive as their preferred document management and oversight platform

The Data Stewardship Platform (DSP) from BackOffice Associates efficiently orchestrates processes that action master and application data - quickly, efficiently, and accurately.

Quartz PCI-CFR is a specialized version of Quartz PCI built for laboratories that must manage digital microscope images in compliance with FDA 21 CFR Part 11 regulations governing electronic records and electronic signatures. It is designed for pharmaceutical, biotechnology, and medical device labs where digital images function as regulated records, not just working files. Unlike text documents, where comparing two versions reveals exactly what changed, it is generally not possible to tell what