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The operation of clinical trials are integral to the progression of the pharmaceutical industry. These trials can be orchestrated on a global scale, producing and distributing the drug in question to participants over several years.
Therefore, the supply of these trials represents one of the biggest challenges to be navigated. Undoubtedly, the efficient management of clinical trial supply entails regulating two dominant variables: Time and money.
As with most sectors, the biotechnology industry is driven by the innovative vigor of small or medium-sized enterprises (SMEs). Most biotechnology SMEs grow slowly and depend on limited financial opportunities from external sources. However, the lack of resources in larger companies and fundamental problems in the models of business prevent most SMEs from succeeding. Competition from larger companies and the lack of marketing capabilities have also battered many opportunities for SMEs. There are three major factors that contribute to the restriction of growth of biotech SMEs: Complicated patenting and costly regulatory systems. Insufficient risk capital for early-stage development. The incongruous marriage between science and business. It is crucial for all new and existing biotech companies to take these three factors into their business model. The key implications of SME research and development depend on the dynamic business models, i.e. a fluid construct model instead of concrete
We at Pharma IQ wanted to hear from the community about what their challenges and priorities in this area are.
We ran the Clinical Trial Supply Outlook Survey throughout July and August 2015. Our community of Clinical Trials professionals let us know the latest from this changing field.
What are the 7 Deadly Sins of Quality Assurance and Quality Control? Download our free QA QC eBook now to find out! Clinical trials play an extremely important role in helping pharmaceutical companies get their products to market. They are designed to ensure the safety and efficacy of new products before they are marketed to the public and they are needed for companies to be granted a licence for their drugs. Approval has to be sought by the regulatory authorities in the individual countries where the pharmaceutical clinical trials are being conducted before they can begin. In the United States, this is the Food and Drugs Administration, while in the UK, the Clinical Trials unit of the Medicines and Healthcare Products Regulatory Authority is tasked with the responsibility. Pharmaceutical clinical trials can be carried out either in-house or by clinical research organisations (CRO), which are also sometimes known as contract research organisations. The Association of
Samantha Carmichael Lead Pharmacist Clinical Trials NHS Greater Glasgow & Clyde Samantha Carmichael has 18 years experience as a pharmacist, having spent time in many different areas of pharmacy, including hospital pharmacy and within the private sector working for a large international pharmaceutical company. She is currently the Lead Pharmacist for Clinical Trials and one of the Lead Sponsor Representatives within NHS Greater Glasgow & Clyde Healthboard. NHS GGC is the largest healthboard in the UK, providing healthcare services to a population of 1.2 million in the West of Scotland. She manages a team of pharmacists and pharmacy technicians who deliver on studies sponsored by NHS GGC or co-sponsored with the University of Glasgow, as well as hosting around 400 CTIMPs across 4 research portfolios, covering all phases and therapeutic areas. She has practised as a clinical pharmacist in the areas of oncology, critical care and anaesthetics.
Forecasting a Brighter Future for Clinical Trial Supply in Emerging Markets- An Interview with Adrian Peskett
Pharma IQ interviewed Adrian Peskett, Clinical Supply Logistics Director at Pfizer Ltd. about his predictions for the future of clinical trial supply in emerging markets. Adrian also speaks about the importance of forecasting in emerging markets and the difficulties in standardising strategy, while meeting countries' individual needs.