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European Pharmaceutical Contractor

Full Service CRO Success

Dr Oriana Zerbini at CROM Srl talks to EPC about CRO management

Tell us about your general concept of CRO management

In my view, the management of a full service CRO can be understood as the result of analysis and operations. Initial activities are mainly aimed at defining strategy, and take into account at least three reference points: the scenario; the customer or sponsor; and the competitors. In practice, analytical activities explore the market and constitute the bedrock of the actual business intelligence held by a CRO. This allows management to be connected to business intelligence – two areas that are often considered very distant from each other. My understanding of management, however, is a proactive vision: operations are the rational, structured response to market demands and opportunities


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Dr Oriana Zerbini, the founder of CROM Srl, specialised in Cardiology at Padua University, in Tropical Medicine and Hygiene at London University, and in Pharmacology at Modena University, as well as being awarded an MA in Communication from Bocconi University in Milan. During the past 14 years at CROM, she has been Medical Director, with experience in project management and expertise in European Directives, and has coordinated more than 200 clinical trials in several therapeutic fields.
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Dr Oriana Zerbini
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4th Annual Patient Recruitment and Retention in Clinical Trials

13-15 October 2008, Amsterdam

Patient recruitment is now consuming thirty percent of clinical trial time - more time than any other clinical trial activity - and almost half of all trial delays result from patient recruitment problems. As the recruiting culture becomes more sophisticated and the forces affecting patient enrollment grow more numerous and complex, pharmaceutical companies are striving to discover new strategies to facilitate enrollment in clinical trials. With increasing industry pressure to develop, test and market greater numbers of new drugs faster, pharmaceutical companies need to perform clinical trials as quickly as possible. Inefficient patient recruitment processes is a formidable barrier to pharmaceutical companies' success in launching new products. Improving the patient recruitment process is imperative to avoid wasted investments and eliminate costly delays in bringing new drugs to market -- today and even more so in the not-so-distant future. Improved patient recruitment presents one of the largest opportunities for pharmaceutical companies to eliminate delays in clinical trials, thereby making it possible to reduce time to market.  With patent time limits and large overheads meaning that any delays in the development timeline can be disastrous, a good understanding of how to successfully recruit patients for trials is vital for any company looking to succeed.
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