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
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.
New labelling requirements: How is the clinical trial supply industry getting ready to stay compliant?
The new Clinical Trials Regulation is to be enforced in 2019 and the clinical trial supply industry is preparing now to remain compliant and companies will have to change their labelling process in order to save costs and stay up to date with the requirements.
In this exclusive article, we have surveyed more than 250 clinical trial supply experts from all around the world to gain insight on where their investment priorities lie in terms of labelling solutions and what their time frame is, in order to better understand how their industry is getting ready to comply with the new legislation.