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Veristat Expands Biometrics Capabilities by Acquiring SQN Clinical

 Veristat, a scientific-minded global clinical research organization (CRO), announced today the expansion of its biometrics capacities by acquiring SQN Clinical, a market-leader in the healthcare arena and one of the largest data focused specialty contract research companies in Europe.
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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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Bio Integrates 2021

20 May 2021, VIRTUAL CONFERENCE

Following the continued success of last year’s inaugural digital event, Life Science Integrates is delighted to announce the 3rd Bio Integrates conference. Addressing the needs of innovative companies developing the therapies of tomorrow, this one-day conference provides a unique forum to discuss the major challenges impacting the sector.
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