Table 1 Descriptions of the organisations publishing on monitoring from the organisation website
Organisation and URL | Short name | Description |
|---|---|---|
Clinical Trials Transformation Initiative | CTTI | Mission: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. CTTI comprises more than 80 organizations from across the clinical trial enterprise. USA based private body, International |
European Medicines Agency | EMA | The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. Public body, European Union |
US Food and Drug Administration | FDA | The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. Public body, USA and further afield |
Health Research Authority | HRA | [HRA] vision is for high-quality health and social care research that improves people’s health and wellbeing, and [HRA] core purpose is to protect and promote the interests of patients and the public in health and social care research. Public body, UK |
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use | ICH | Brings together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Private body, International |
Medicines and Healthcare products Regulatory Agency https://www.gov.uk/government/organisations/medicines–and–healthcare-products-regulatory-agency | MHRA | Regulates medicines, medical devices and blood components for transfusion in the UK. Public body, UK |
National Institute for Health Research | NIHR | The UK's largest funder of health and care research and provide the people, facilities and technology that enables research to thrive. Working in partnership with the NHS, universities, local government, other research funders, patients and the public, [NIHR] deliver and enable world-class research that transforms people's lives, promotes economic growth and advances science. Public body, UK |
TransCelerate Biopharma Inc | Trans-Celerate | Aim to collaborate across the global biopharmaceutical research and development community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high-quality delivery of new medicines. USA based, international |
UK Trial Manager Network | UKTMN | Aims to facilitate the development of a well-trained, highly motivated, effective workforce of trial managers within the UK health care system who will make an important contribution to the efficient delivery of high quality clinical trials. Private body, UK |