Clinical
Clinical Trial Software
Study information. Documents. Tasks. Sites. Collaborations. The wide-ranging list of components that must be administered and maintained throughout the course of a clinical trial goes on forever. And the task of managing and controlling them all is monumental. With MasterControl, you can seamlessly connect clinical study data and effectively link all the documents and artifacts that make up your electronic trial master file (eTMF) — all on a single platform.
Achieve clinical mastery. Collect and connect data in a single system.
Integrated Study Management
MasterControl unites site monitoring, performance, vendor audits, training and other study activities in one system. Our clinical management software makes it easier to gather information from multiple sites and contract organizations. Designed with the user in mind, it simplifies the collection, control and alignment of site data and TMF documents in each stage of the clinical life cycle.
Robust eTMF Management
There are hundreds of TMF artifacts in continual flux throughout a clinical study. MasterControl eTMF software systems let you plan, assign, create, review and approve them all with greater efficiency. Our best practice eTMF configuration is the ideal model for guiding clinical experts from study initiation to study closeout.
Consolidated Clinical and Quality
Your various sites, contract research organizations (CROs) and vendors may all have their own way of doing things. But they need a means of staying on the same page – especially when it comes to managing quality. MasterControl allows you to align clinical operations and quality event management across all your activities. It provides comprehensive audit management capabilities as well.
Complete GCP Document and Training Management
Our clinical management software is designed to make it easier to align with good clinical practice (GCP) guidelines. With MasterControl, bridging the gap between GCP training and the management of quality documents has never been simpler.
Trusted By
The Ideal Foundation for TMF Management Excellence
Our eTMF software is based on the Drug Information Association (DIA) TMF Reference Model. This industry standard configuration is combined with MasterControl's process management excellence so you can see all TMF activities in real-time. The free Excel-formatted TMF checklist – based on the TMF Reference Model – outlines the way MasterControl helps users collect and manage TMF documents.
Seamlessly Integrated Quality and Clinical Operations
When clinical and quality functions work together, outcomes improve dramatically. Our clinical solutions link perfectly with the MasterControl Product Lifecycle Excellence platform. This unity lets you embed quality processes directly into your clinical trials. With our holistic solutions, you have all the tools you need to effectively manage risk and ensure GCP compliance.
Keep your vital clinical data connected.
Harmonize all the documents and artifacts that comprise your TMF in one robust system.
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