Some Reference Sites


Medicines and Healthcare products Regulatory Agency (MHRA)
Department of Health agency dedicated to ensuring the safety of medicines and medical devices.

Good Clinical Practice (GCP)
The US Food and Drug Administration provide documentation on Good Clinical Practice for clinical trials based in the US and internationally.

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
An international group of pharmaceutical experts concerned with establishing and maintaining optimum medical product registration and public health across Europe, Japan and the United States.

European Medicines Agency (EMEA)
A decentralised body responsible for protecting and promoting public and animal health by evaluating and supervising the use of medicines.

ClinicalTrials.gov provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.

Drug Information Association (DIA)
Providers of information on the discovery, development, and life cycle management of pharmaceuticals, medical devices, and related products.

National Library of Medicine (NLM)
The world’s largest medical library providing a wealth of medical information and online exhibitions.

Warning Letters
Database of warning letters sent by the US Food and Drug Administration to companies who have been non-compliant with regulations.















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Case Studies

CASE STUDIES

CRA Team - Provision of a CRA Team for Cardio-Vascular Study

Klinikos was contacted by a pharmaceutical client to provide a team of experienced CRAs who could monitor a phase III cardio-vascular study across 5 european countries. – France, Germany, Italy, Spain and the UK.

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TIPS & GUIDES

PDF Download some free templates for use in clinical research trials and improve your efficiency.

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