Contract research organisations clinical

The minimum standards for the facilities in which clinical pharmacology studies should be conducted are described in the ABPI guidelines. Clearly, the same standards should apply to pharmaceutical companies, academic units and contract research organisations. In the UK, the Medicines Control Agency has instituted inspection of facilities and procedures, and a system of certification will be implemented. 

For the first time, contract research organisations (CROs) have been formally recognised. Previous legislation described as an in-country caretaker someone who operates as a CRO for foreign pharmaceutical companies aiming to obtain Japanese product approval without establishing a formal entity within Japan. Such activity was not open to Japanese pharmaceutical companies, as they were expected to have the full capacity to conduct clinical trials in Japan. 

The results derived from this ongoing research are important to development of the CIPA initiative currently ongoing between the pharmaceutical industry, contract research organisations and regulatory authorities (FDA) (Sager et al. 2014). The establishment of datasets of clinically used compounds should provide much needed information to the entire scientific community regarding adoption and applicability of in silico simulations in safety hazard identification as well as the nature of the data derived from HTS (vs. patch clamp) methods subsequently used in simulation methods. 

The arrangements made for the conduct of clinical research wiU usually give rise to a number of legal contracts. For example, there will be a contract between a sponsor and any appointed clinical research organisation (CRO) between the... 

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