Mastering Trial Quality Is Possible With the Right Plan.

Conducting a clinical trial is a study in complexity. And with so much riding on the outcome, it’s vital that the quality of both the trial results and your trial master file is flawless. So how do you ensure the data and documentation generated from your clinical trials transfers seamlessly throughout a product’s regulatory, production and postmarket life cycle?

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Step 1: Streamline Your Master File

Between sponsors, CROs and multiple study sites, it’s essential that key stakeholders can access, upload, review and collaborate on the electronic trial master file (eTMF) in real time. MasterControl Clinical Excellence simplifies the collection and organization of GCP and TMF data and documentation across sites and CROs so you can easily manage and configure the eTMF structure, review documents and data, and ensure visibility and collaboration throughout the entire clinical process.

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Step 2: Embed Quality Into Clinical Operations

Successfully managing the quality of any clinical study requires more than just a central place to store TMF documents. Clinical teams must embed quality into day-to-day processes by combining the activities managed by clinical operations and clinical quality. Unlike traditional clinical trial management systems that only collect data and documentation, MasterControl’s clinical quality management system (CQMS) offers a holistic approach to managing quality and risk throughout a clinical trial.

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Step 3: Accelerate Trials With Real-Time Visibility

Eliminating process bottlenecks is essential to accelerating the clinical life cycle and improving the likelihood of successful trials. MasterControl's Clinical Excellence solution provides real-time visibility into critical clinical processes across operational teams and automates data and documentation processes so you can easily manage your eTMF content, site protocols, SOPs and reporting across study sites.

Solution Offerings

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MasterControl Clinical Excellence

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MasterControl Clinical Excellence

Explore the following topics: electronic trial master file (eTMF) document management, integrated clinical quality management system (CQMS) , vendor management (CROs, IP distributors, etc.), audit management (study, sites, vendors, etc.)

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MasterControl Quality Excellence

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MasterControl Quality Excellence

Explore the following topics: industry-leading enterprise quality management system (QMS), documents and change control, integrated training and exams, robust CAPA and audits, risk mitigation.

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Discover the MasterControl Platform

The MasterControl Platform is the foundation for complete product quality – connecting applications, documentation and data across your entire product development life cycle, from concept to commercialization.