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European Pharmaceutical Contractor
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Last year, the Tufts Center for the Study of Drug Development reported that the cost of developing a new drug now averages $897 million, a staggering figure by any standard. Although this amount has been challenged, it is little wonder that biopharmaceutical companies are continually seeking ways to accelerate the development process to get to market faster in order to begin recouping these huge costs. Technology has been a boon to improving several areas within research and development, especially in the conduct and management of clinical trials. Some examples include clinical data management systems (CDMS), clinical trial management systems (CTMS), electronic data capture (EDC), drug supply management (DSM) and interactive voice response (IVR) systems. However, these systems are generally used in isolation, despite the fact that they often affect common processes and use overlapping information. Obviously, this is not the most efficient use of resources.
As an increasing number of clinical systems are used, there is a growing need to share data between these silos of information. Currently, experts conservatively estimate that the biopharma industry is spending more than $150 million per year on data exchange. These costs include, for example, the manual work required to import and export data between applications, and the associated data reconciliation activities.
Such manual manipulation of data is very slow and inefficient, often leading to delays in regulatory submissions, and delays are extremely costly in terms of lost sales opportunities. Further, the ad hoc movement of clinical information from one system to another does not yield the benefits that could be realised by truly integrating these solutions. By integrating technologies and processes, clinical trial sponsors can eliminate redundant tasks that not only waste time, but can also result in the creation of conflicting information. Integration can also greatly accelerate the flow of critical information to key stakeholders, thereby helping them to make decisions sooner.
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By David B Stein, Director of Strategic Business Development, Marie MacDonald, Systems Manager at ClinPhone Inc, USA, and Bill Byrom, Product Development Director at ClinPhone Group Limited, UK
David B Stein, BSc, is the Director of Strategic Business Development at ClinPhone Inc. He is also a member of the company's US management and strategy teams and the new products group. David has led several start-up ventures including Provenda Biometrics, a pioneer in electronic patient diary systems. He also established and directed the data management department for a mid-sized contract research organisation. More recently, he was Director of Strategic Business Development at PhaseForward.
Marie MacDonald, BSc, holds primary responsibility for ClinPhone's interactive voice response (IVR) and interactive web response (IWR) services and external systems. She also provides consultation and training for client companies using IVR. Marie has held positions in the health care industry for 19 years, including experience as a Systems Manager for a major pharmaceutical company, and as an IT Business Consultant specialising in data warehousing and business process re-engineering.
Dr Bill Byrom joined the pharmaceutical industry in 1991 after completing a PhD in disease modelling related to animal health at Strathclyde University. He has worked for a number of pharmaceutical companies in a variety of roles, including Statistician, Clinical Study Director, Medical Marketing Representative and Health Economist. His experience in therapeutic areas includes diabetes, asthma, heart failure and schizophrenia. Bill joined ClinPhone in July 2000, where he is Product Development Director, working globally on the development and commercialisation of ClinPhone's new products and services.
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Industry Events |
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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.
More info >> |
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News and Press Releases |
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Aegate Proves Authenticating Drugs at the Point of Dispensing Protects Consumers
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