Contracts contract research organisation

The pharmaceutical physician will be very familiar with certain types of contracts, depending on his/her role within the company. Examples include agreements with contract research organisations, contracts for the sale of the finished pharmaceutical product and licensing or distribution agreements. 

Information on Contract Research Organisations, if involved Environmental assessment or exemption declaration... 

Dr Georg Geisler is a product safety expert and modeller working with RCC Ltd, a Contract Research Organisation based in Basel, Switzerland. In this function, he conducts environmental risk assessments of pesticides, biocides and other chemicals, as well as safety assessments for pesticide residues in the food chain. In 2003, Georg Geisler earned his Ph.D. on environmental life-cycle assessment of pesticides at ETH Zurich. In 1999, he had received a Diploma in environmental chemistry at the Friedrich-Schiller University, Jena, Germany. 

To develop robust methods, you have to keep in mind that simple methods are preferable. Also, if you have a chromatographic background, then the factors affecting CE precision (and to a lesser extent accuracy) are widely different to HPLC, which is currently the predominantly employed technique for drug assay. There is no general preference for the choice between techniques CE, LC, or other. The choice should be made on a scientific basis, supported by the relative merits of the techniques for the specific problem and factors such as the experience of the method-developing scientist. Robust CE methods have been successfully transferred to relatively inexperienced QC and Contract Research Organisation (CRO) labs. 

The majority of healthy volunteer studies are conducted by contract research organisations (CROs), which recruit subjects from the general public by advertising and word of mouth. The composition of the volunteer database depends to some extent on the location, some being comprised mainly of students or the local residential population, others, particularly in large cities, having a preponderance of backpackers and temporary workers. The source of volunteers does have implications for safety, motivation and withdrawal rates. The more itinerant volunteers may not be available for follow-up and little may be known about their medical background. While the professional volunteer is wholly inappropriate, a stable population of volunteers who understand what is involved... 

Food and Drug Administration (FDA). Compliance Program Guidance Manual (7348.810) Sponsors, Contract Research Organisations and Monitors. Rockville, MD Division of Compliance Pohcy, 1999. 

Contract research organisations are likely to be more efficient, and on occasion can be faster than the company. A balance has to be struck between the outsourcing costs, internal costs (which are often underestimated) and the management requirements and skill sets of the CRO and internal staff. 

More trials, with greater numbers of subjects, necessitate utilisation of outside consultants and contract research organisations to manage sites, collect and verify data, assure protocol compliance plus adherence to GCP regulations. The number of outside companies who draw their livelihood from the growing size and complexity of the drug development process is itself an ominous portent. 

Contract research organisations (CROs) are formally recognised in the new GCP, as it explicitly stipulates that the sponsor may contract all or... 

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. 

Characterisation issues can, however, become very contentious ones, especially when they relate to the testing of an item by a Contract Research Organisation (CRO) as test facility, to which the sponsor of the contracted study delivers an off-white powder in some sort of a container, labelled with SPO-00115-xyz or some other such code. The sponsor may possibly not want to disclose the exact identity of this test item, nor to provide the analytical method to be used for ascertaining the homogeneity, concentration and stability as it is demanded by the GLP Principles. Thus, the CRO will not be able to confirm, in a GLP compliant manner, these properties what is even more problematic, the CRO cannot, in such a case, ascertain whether the coded item received at the test facility indeed corresponds to the item that has been intended for testing. If there were no way of ascertaining the identity of a coded substance utilised in a certain study, it would be possible to substitute this study for a study of another test item where an unfavourable outcome had been noted. 

Committee for Veterinary Medicinal Products (CVMP) 203, 204 complement activation 270, 273 complex PK/PD model 169 Contract Research Organisations (CROs) 129 Coomassie 49 copegus 136 Coptis japonica 29 copyright 187 corapporteur 204 com 37 COS-1 260 cosmetics 206 Creutzfeld-Jacob 120 Crohn s disease 132 crop cultivation 35 cross-presentation 82 cross-reactivity 106 CSF 225 CVM 207 cydohexamide 13 cydosporin 25 cydosporine A 12 cystic fibrosis 183, 250 cytochrome P450 17, 151... 

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