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European Pharmaceutical Contractor
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Site Selection and Investigator Identification
Highly critical to the success of any study, these two issues require the utmost care. The decision-making process regarding both site and investigator should make full use of all local expertise:
Local opinion leaders will be well acquainted with the available professionals in the
area, as well as with its hospital structure and facilities
Local CROs and pharmaceutical companies' affiliate offices (affiliates) will have
hands-on experience of potential investigators and sites
This expertise should provide valuable information regarding site potential and suitability for trial requirements, for example available beds, medical/lab equipment, clinical supply, storage facilities and so on. They can also be helpful for assessing a site's desirability, for instance location, physical layout, access to IRB/IEC, quality of clinical trial teams and a suitable patient pool. Utilising these resources, whilst fundamental, is not without potential problems.
For example one should always be aware of the risk of commercial interests affecting advice given by affiliates during site/investigator selection. In an emerging scientific market commercial potential is limited, and therefore sales and marketing opportunities should be carefully balanced with clinical development. In our opinion, the emphasis should be put on clinical development performance. It is much more important to assess a site's real suitability and an investigator's capabilities in new drug trial implementation, rather than future marketing potential.
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In our Summer 2002 issue, Dr Milen Vrabevski, Medical Director at Comac Medical, began an in-depth overview of clinical trials in his native Bulgaria. Here he continues his investigation of the advantages and potential pitfalls for multinational pharmaceuticals operating in emerging scientific markets.
Dr Milen Vrabevski is Medical Director of Comac Medical Ltd., a full service small CRO based in Sofia, Bulgaria. He has over five years of experience in the pharmaceutical industry, mainly in the field of clinical research.
After graduating from the Medical University of Varna in 1995, Milen began his career working as a Junior Doctor in a surgery department, and then as a Medical Representative of a pharmaceutical company before founding Comac Medical Ltd. in 1997, assuming the position of Director.
Being one of the pioneers in the GCP and Quality of Life (QoL) area in his country, Milen has participated in conducting all company clinical studies and QoL projects.
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Small Scale Biomanufacturing – clinical trials, cell & gene therapies
18 September 2008, Clifton Pavilion, Bristol Zoo Gardens, Bristol
This one day conference, sponsored by bioProcessUK and organised by BioApproaches South West, will cover key, important topics relating to small scale GMP biomanufacturing.
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News and Press Releases |
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Azopharma Product Development Group, Inc
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today the addition of innovative state-of-the-art equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, Florida. The most recent acquisition is the MG Futura Capsule Filler which delivers the latest in capsule filling technology. The company has also added a Bausch & Strobel Aseptic Filling Isolator, equipment that is ground-breaking in the powder filling process. These additions support our previously implemented XcelodoseTM powder micro-dosing system. With these technologies, Azopharma is able to provide its clients with all forms of the capsule filling process. The new equipment is part of Azopharma’s recent manufacturing expansion which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products...
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