Products

PhlexTMF is an advanced electronic Trial Master File (eTMF solution designed to ensure the completeness, timeliness, and accuracy of clinical trial documentation throughout the study lifecycle. Developed by Phlexglobal, a recognized authority in TMF best practices, PhlexTMF integrates cutting-edge artificial intelligence to enhance document management efficiency and reduce inspection risks. Key Features and Functionality: - AI-Assisted Document Management: Utilizes pre-trained AI to prevent mi

ComplyDocs eTMF is an electronic Trial Master File (eTMF solution designed to digitize and streamline the management of essential clinical trial documents. By transitioning from traditional paper-based systems to a digital platform, ComplyDocs eTMF enhances the efficiency, accessibility, and compliance of clinical trial documentation processes. Key Features and Functionality: - Digital Document Management: Enables the electronic capture, organization, and storage of all essential clinical tria

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

ConciergeTMF is an innovative Software-as-a-Service (SaaS) provider specializing in Research and Development (R&D) archival management. Their unique approach transcends traditional software solutions by offering a comprehensive platform that seamlessly blends technology and human expertise. Key features of ConciergeTMF's platform include: Human-in-the-Loop Intelligence: At the core of ConciergeTMF's offering is the fusion of AI technology with human oversight. This synergy ensures that doc

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

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

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.

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

Velos eResearch connects financial, administrative and clinical research activities, you can do away with the patchwork of manual and partially automated systems common in clinical research today.

A new breed of cloud-based, patient-centric data capture solutions designed to handle both ePRO and EDC on BYOD.

ThoughtSphere’s mission is to help life science companies develop and deliver treatments to patients faster and smarter using data science. With our innovative platform, biopharma, medical device sponsors and CROs not only can reduce and optimize clinical development costs but also enhance efficiency and effectiveness in the clinical trial processes, and gain near real-time actionable insights. Founded by clinical information and technology industry experts, ThoughtSphere aims to deliver on the

Jeeva eClinical cloud helps clinical researchers, patient advocacy groups, clinical research organizations (CROs), public health research organizations, and Biopharmaceutical sponsors to accelerate remote patient recruitment by 3x faster by reducing the logistical burdens on patients and study teams by over 70%. This modular software design allows a rapid study configuration with the features and workflows that fit the specific trial protocol whether short-term or long-term, cross-sectional or

Take your clinical trials to the next level Optimize the management of your clinical trials in just a few clicks and focus on the essentials with Datacapt. 100% Secure and Compliant!

LifeSphere is an end-to-end life sciences platform, using ArisGlobal’s proprietary Nava® cognitive computing engine to automate all core functions of the drug development process. Offering simple integration with our next-generation LifeSphere EasyDocs document management solution across the product lifecycle, the LifeSphere platform helps life sciences companies reduce time to market, increase compliance and lower drug development costs.