The Clinical Landscape is Evolving
Outsourcing to CRO’s continues to increase due to the globalization of clinical trials, and the need for sponsors to do more for less. Experienced CROs are typically able to increase efficiency, generate cost savings, and improve access to treatment naïve patients. Competition in the CRO market is fierce and gaining competitive edge can sometimes be challenging in such a crowded marketplace. Technology can be a differentiator, and Montrium focuses on helping CROs empower their people and processes through innovative technology.
We Know What’s Important to You.
As the use of technology continues to increase within clinical trials, it is important for CROs to be able to offer technological solutions to their clients while also leveraging technology in their everyday work to become more cost-effective. Montrium has been working closely with CRO clients to develop tools which allow them to add value to their existing services. Notably, we have developed multi-sponsor environments for the management of the eTMF and regulatory documents. CROs can collaborate externally with sites, sponsors and other stakeholders to centrally create, collate and manage eTMF and regulatory records. These records are available to sponsors at all times, helping them better understand and manage their clinical programs or regulatory submissions. Inspection readiness is also key and we have built tools which facilitate the navigation of records during audits and inspections, helping both the CROs and sponsors to always be in compliance.
Finally, we are able to provide a fully integrated online quality management system which improves compliance with SOPs and training and allows CROs to proactively manage quality while minimizing the cost of quality and adding true value to clinical quality management.
- Improve collaboration with sponsors and sites
- Optimize Clinical Operations
- Improve Document Collaboration
- Centralize value-added quality management
Our Solutions for CROs
We have built Montrium Connect with CROs in mind. Our on-cloud or on-premise offerings allow you to easily add electronic document and quality management tools to your service portfolio.
eTMF Connect – The Smart Way to Manage TMF Content
Montrium’s proven eTMF Connect solution helps life science companies better manage their clinical trial documentation. It has been designed using the TMF Reference Model, and centralizes and standardizes your clinical records enabling both sponsors and CRO’s to contribute and access important clinical documents and information in real-time.
RegDocs Connect – Automate the Creation of Submission-Ready Content
RegDocs Connect gives your operational and regulatory teams the tools they need to prepare complete and compliant submission ready documents and records. Built with the end user in mind, collaboration, automation and quality are the foundation of this solution.
SOP Connect – Automate the entire lifecycle of your controlled documents
Montrium’s SOP Connect module is designed to manage all controlled documents that form part of your quality system. Easy access, centralized distribution, intuitive workflows and strong integration with our Training Connect module ensure that quality and compliance are at the heart of your operations.
Training Connect – Facilitate the Planning and Completion of GxP Training
Training Connect facilitates the planning and completion of SOP or regulatory training. An integrated training matrix coupled with intelligent form technology allows you to track and manage employee training more efficiently, ensuring that you meet all training requirements.
CAPA Connect – Centralizing and Empowering Continuous Improvement
CAPA Connect is an integrated deviation, incident and CAPA management solution which allows you to manage all of your quality events in one central location. CAPA Connect has intuitive forms and workflows which adapt based on the type of quality event being managed.