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able and realistic. It is not uncommon to hear a pharmaceutical company staff admit that the timings they require from CROs could not possibly be met internally. |
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Allocation of responsibility within the pharmaceutical company for decisions to be taken and for the subsequent management of the contract is vital. Although the contract staff may be responsible for ensuring communication of decisions, it must be the project head and budget holder who has decision making authority. Once the study is awarded, it must be clear who within the company is responsible for what. The clinical team or data management team have clear responsibility to oversee the contract and ensure that timings, quality, and patient enrollment are being met. However, it is usually good practice to appoint a contract person for all queries which arise. This avoids confusion and also avoids the possibility that decisions made by one group or person within the company are not communicated to others who may be affected by the decisions. By ensuring that the steps described above are addressed a pharmaceutical company should, at least, start out in control of the contracting process. |
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III.
Approaches to Selecting a CRO |
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The CRO market has seen a plethora of mergers and acquisitions in the 90s. In the main, these have been aggressive mergers with the objective of expanding either services offered or widening the geographical cover. Now, the major CROs all offer full service and some, notably Covance, Quintiles, and ClinTrials Research, offer preclinical and clinical services. The major players in these acquisitions have been companies based in the U.S.A. They have acquired operating groups in many European countries and beyond as a response to requests from their major sponsors to conduct global studies. The medium-sized, independent CROs, which have not been acquired, in some cases, have sought to form alliances with others to offer pan-European capabilities or have sought U.S.A.-based partners with whom to work in multinational studies. However, the difficulty of organizing trials to essentially the same standards across several independent organizations has usually proven to be too great a challenge. The joint venture, where all partners have a financial interest in the contracts each other is bidding for, has been much more successful. |
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Technomark Consulting Services has stated that there are 262 CROs in Europe alone and that there are now eighteen public CROs in the U.S.A. with an equity value approaching $1 billion employing 10,000 staff. Thus, |
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