Ethics/Regulatory

Exco InTouch receives privacy shield framework self-certification

Tuesday, January 17, 2017

ERT company Exco InTouch, a provider of digital patient engagement and data capture solutions for clinical research and healthcare providers, has formally received EU-U.S. Privacy Shield Framework Self-Certification status by the U.S. Department of Commerce’s International Trade Administration (ITA). The designation certifies that Exco InTouch’s practices meet or exceed the data privacy and security principles outlined by U.S. Department of Commerce and European Commission.

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NCI’s new drug formulary will expedite agent use in clinical trials

Wednesday, January 11, 2017

The National Cancer Institute (NCI) has launched a new drug formulary that will enable investigators at NCI-designated Cancer Centers to have quicker access to approved and investigational agents for use in preclinical studies and cancer clinical trials. The NCI Formulary could ultimately translate into speeding the availability of more-effective treatment options to patients with cancer.

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EMA to offer advice for new biosimilars

Tuesday, December 20, 2016

The EMA will launch a pilot project in February 2017 to test the added value and feasibility of tailored scientific advice for the development path of biosimilar medicines. Through this new initiative, EMA aims to provide developers of biosimilars with advice on the studies/tests they should be conducting, on the basis of the quality, analytical and functional data they have already available for the medicine.

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Commonwealth Informatics, FDA sign consultation agreement

Thursday, December 15, 2016

Commonwealth Informatics, a provider of clinical and safety analytics products and services, signed a new contract to support the use of advanced drug safety review tools at the FDA Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The focus of the agreement is for Commonwealth to support the expansion of the use of the analytic suite of tools to help FDA manage their drug and product safety proactively and strategically in drug approval and post market surveillance.

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Report: Clinical research benefits the U.K. economy

Friday, December 2, 2016

An independent report, commissioned by the National Institute for Health Research (NIHR) Clinical Research Network and produced by KPMG’s Economics team, provides an assessment of the economic impact of the NIHR Clinical Research Network’s activities to support clinical research in the U.K. The report includes assessment of the economic contribution made to the U.K. economy through clinical research activity supported by the network; analysis to quantify the value of payments made to NHS Trusts for commercial studies, and the value to the NHS of pharmaceuticals used as part of industry-sponsored studies.

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