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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HHS/NIH finalize requirements for clinical trial reporting

Sunday, January 1, 2017

Faced with noncompliance of required reporting of clinical trial information, the U.S. Department of Health and Human Services (HSS) issued a final rule last September that gave more specifics about registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The rule also expanded the legal requirements for submitting registration and results information for clinical trials involving FDA-regulated drug, biological, and device products. National Institutes of Health (NIH)-funded trials fell under reporting requirements, as well, as the NIH issued a complementary policy at the same time. NIH-funded trials must register and submit summary results information to ClinicalTrials.gov even if the trials are not subject to the final rule. Although the enhancements add measures to improve the amount of clinical trial information on ClinicalTrials.gov, some researchers in favor of total transparency say that enforcement action and penalties still fall short.

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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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Three Questions: Irina Petrova, M.D., OCT

Monday, December 12, 2016

CWWeekly presents this feature as a spotlight on issues faced by executives in clinical research. This week, writer Karyn Korieth spoke with Irina Petrova, M.D., director of Clinical Operations at OCT, a full-service CRO based in Russia that also operates in Europe and the U.S.

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