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Research Quality Association

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Quality Systems Guide

This guide concentrates on the core, underlying principles of quality that are pivotal explicitly or implicitly to all quality management standards that impact on research and development.

These principles are also fundamental to the conduct of efficient, reliable and credible scientific and clinical work, and will help you to design and implement a practical Quality System; a Quality System that works for your organisation, to make it more productive and compliant, rather than making you work for it by producing unnecessary bureaucracy.
Quality Systems Guide
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News and Press Releases

Shionogi, Active Citizenship Network and Meps Advocate for Urgent Policy Implementation in Eu Member States at Eu Parliament Event to Address the Growing Threat of Antimicrobial Resistance

OSAKA, Japan and AMSTERDAM, NL, 28 November 2022 Shionogi & Co., Ltd. and its European subsidiary, Shionogi B.V. (hereafter "Shionogi"), held an event at the EU Parliament last week in the run-up to World Antimicrobial Awareness Week, joining forces with MEPs, Active Citizenship Network and MEPs Interest Group on "European Patients' Rights & Cross-Border Healthcare" to discuss initiatives to tackle AMR. The event reinforced the need for urgent attention and collaboration from pharmaceutical companies, policy stakeholders and governments to bring about policy change and innovation to address this growing issue.
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White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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