Products

Centralized Monitoring Built for Modern Clinical Trials Improve trial performance by up to 30% with monitoring that reduces complexity and keeps your study on track. Focus on what matters most • Vizualize changes over time instantly • Quickly identify critical risks by uncovering hidden insights • Minimize wasted effort by directing attention where it’s needed Confidence in every decision • Full visibility with intelligent, dynamic data structures • Adapt easily to emerging needs and regulatory

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

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

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

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

A leading Clinical Trial Knowledge Platform, offering a transformative collaboration channel and clinical trial oversight.

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.

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

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

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.

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

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.

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

SureETMF is a cloud-based electronic Trial Master File solution designed to streamline the management of clinical trial documents and data. It enables biotechnology and pharmaceutical organizations to capture, collect, share, view, digitally sign, store, and manage documents, medical images, videos, clinical trial data, and other electronic content essential for medical research. Key Features and Functionality: - Comprehensive Document Management: Facilitates the organization and retrieval of

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

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

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!

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