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The DRKS is an open access, free of charge online register for clinical trials and is available both in English and German. DRKS is part of the WHO's ICTRP. The DRKS works with two partner registries in Germany, DeReG (German Registry for Somatic Gene-Transfer Trials) and Clinical Trial Registry of the University Medical Center Freiburg. [4]
In May 2015 it prompted a judicial review to prevent new rules from the UK Health Research Authority (HRA) from being implemented in April 2015. [4] The new rules mandated that all drug companies and CROs in the UK register all clinical trials before the first participant is recruited, declare who sponsored the study, and publish the outcome of studies, not only for future trials, but for ...
The Medical Research Council (MRC) is responsible for co-coordinating and funding medical research in the United Kingdom. It is part of United Kingdom Research and Innovation (UKRI), which came into operation 1 April 2018, and brings together the UK's seven research councils, Innovate UK and Research England.
Established by its Office for Clinical Research Infrastructure in 2011, the NIHR has eight Translational Research Collaborations – ready-formed networks of the UK's leading universities, NHS trusts and research centres that conduct early-phase translational research and tackle experimental medicine challenges in selected therapeutic themes.
The European Union Clinical Trials Regulation (regulation (EU) No 536/2014) is the legislation relating to the conduct of clinical trials of investigational medicinal products within the European Union. The regulations repealed the previous legislation, namely the clinical trials directive and came into force on 31 January 2022. [1]
The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, a 2015 Swiss NGO of pharmaceutical companies and others, defined a contract research organization (CRO), specifically pertaining to clinical trials services as: [8]: 10 "A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or ...
The UKCRC evaluates CTUs in the UK and they may be given either Full or Provisional CTU registration status. All Registered CTUs are required to provide evidence that their work is of high quality by demonstrating (1) experience of coordinating multi-centre randomised controlled trials or other well-designed studies, (2) a presence of a core team of expert staff to develop studies, (3) a ...
The leading cause of missed clinical trial deadlines is patient recruitment, taking up to 30 percent of the clinical timeline. [3] Improving patient recruitment rates offers pharmaceutical and medical device companies one of the biggest opportunities to accelerate the pace of clinical trials – making it possible to reduce time to market. As ...