CROs/Service Providers

KCR’s ethical assessment of clinical trials following EU CTR implementation

Thursday, March 30, 2017

Since the publication of the EU Clinical Trial Regulation (CTR) 536/2014 in the Official Journal, a new scheme of Clinical Trial Application (CTA) has been developed. Although certain rules for timelines, coordinated assessment and IT infrastructure are detailed, it remains up to each Member State how to organize ethical assessment and the cooperation of the Ethics Committee(s) (ECs) with National Competent Authorities (NCAs). KCR’s Anna Kubik, director Regulatory Affairs, who is a speaker at the DIA EuroMeeting this year, presented an overview of the current status focusing on the development of local requirements in terms of ethical assessment as well as proposed schemes respectively.

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INC Research accelerates clinical trial startup with goBalto Activate

Wednesday, March 29, 2017

goBalto, a provider of cloud-based clinical study startup solutions, announced results from its ongoing partnership with INC Research, a global CRO and pioneer in the implementation of goBalto’s end-to-end study startup platform to accelerate delivery of phase I to IV clinical trials for global biopharmaceutical customers. INC Research continues to optimize its clinical study startup process on a worldwide basis, leveraging goBalto’s technology to start more than 220 studies in more than 68 countries to date.

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Charles River Laboratories International to pay $1.8M to settle False Claims Act allegations

Friday, March 24, 2017

Charles River Laboratories International has agreed to pay the U.S. government $1.8 million to settle claims that it violated the False Claims Act by improperly charging for labor and other associated costs that were not actually provided on certain NIH contracts, the Justice Department announced. Charles River is a for-profit corporation headquartered in Wilmington, Massachusetts. 

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PPD launches apprenticeship for Clinical Research Associates

Thursday, March 23, 2017

Pharmaceutical Product Development (PPD) launched a clinical research associates (CRAs) apprenticeship program targeted to military veterans and military service members with medical backgrounds who are transitioning to the civilian workforce. PPD’s initiative, the first CRA apprenticeship program registered with the U.S. Department of Labor, will begin in North Carolina, Texas and California in the first quarter of this year.

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Thermo Fisher Scientific, Cell and Gene Therapy Catapult collaborate

Tuesday, March 21, 2017

To help address the challenges surrounding supply chain management for cell and gene therapy around the globe, Thermo Fisher Scientific announced a collaboration with the Cell and Gene Therapy Catapult (CGT Catapult) to provide developers with both the manufacturing capability and distribution, logistics and storage capacity needed to create a seamless supply chain to accelerate cell and gene therapy development and commercialization.

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Metrion Biosciences, Concept Life Sciences launch ion channel drug discovery service

Wednesday, March 15, 2017

Metrion Biosciences, a specialist ion channel CRO and drug discovery company, and Concept Life Sciences, the business formed in 2014 to break into the international integrated discovery & development and analytical markets, have announced a strategic alliance to provide pharmaceutical clients with fully integrated medicinal chemistry and biology research services for ion channel drug discovery.

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BioreclamationIVT acquires TransCell Science

Thursday, March 9, 2017

BioreclamationIVT has acquired TransCell Science, a privately held CRO specializing in the use of primary cells for phenotypic screening assays. With its scientific expertise in the areas of cell culture and cell-based assays, clients have looked to TransCell as a partner in developing protocols and conducting studies that provide pertinent data for their research programs. The output from such studies enables “go” or “no go” decisions with a higher level of confidence at a much earlier time point within the drug discovery process and greatly reduces the chance of downstream failure.

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