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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KCR celebrates 20th anniversary

Tuesday, February 7, 2017

In 2017, KCR celebrates its 20-year anniversary of contributing to the clinical R&D industry. The CRO was founded in 1997 by entrepreneur Marek Kiecana. Emerging from Central Europe, KCR today operates in 19 European countries as well as the U.S. and provides pharma and biotech companies with fully customized service solutions for optimized clinical trial execution.

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Three Questions: Mike Jagielski, KCR

Monday, March 7, 2016

CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Suz Redfearn spoke with Mike Jagielski, CEO of the Berlin-based CRO KCR (Knowledge Commitment Results).

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KCR opens new entities in Western Europe

Wednesday, March 5, 2014

European CRO KCR, which operates across 18 countries in Europe as well as in the U.S., has recently registered new entities in the U.K. and Germany. This move is part of the company’s strategy to bring the business closer to Western European customers and deepen client relationships.

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