It is up to pharmaceutical companies sponsoring clinical trials in the EU to have comprehensive control of their supply chain. This ensures the quality of their drug supply is not compromised and patients are not inadvertently administered counterfeit or falsified drugs.
Article by Sue Mann, founder and Managing Director, Sue Mann Consultancy Ltd
The QP process is a necessary process that every sponsor company wishing to undertake trials in, or move product through the European Union must undergo. When faced with this process, many companies are unsure as to what to expect. Here are the top ten things that sponsor companies should know about the QP Process.
Bringing a new drug to market can be a heavy financial burden on any pharmaceutical company. It has become even more burdensome over the last several years as the industry pushes the boundaries of innovation. This is because newer, often more-complex therapies not only increase risk in drug development but also drive costs even higher.
As the cost and complexities of drug development increase, so do the challenges of global clinical trials. Today’s sponsors must be able to manage and coordinate multiple resources, processes, and locations with speed and accuracy to design effective and efficient clinical trials. Securing a stable supply chain to deal with the uncertainties of clinical trials is critical. One misstep can have a profound impact not only on the cost and time of your trial but also on its overall success.
From virtual biotech companies to large pharmaceutical companies, outsourcing is a key consideration in clinical packaging and distribution. According to Sherpa Clinical Packaging, however, although outsourcing is a valuable strategy for companies of all sizes and capabilities, it should be entered into for reasons specific to a company’s requirements.
Sometimes it makes sense to ask for a helping hand from a clinical trial management expert. Mark Paiz from Sherpa Clinical Packaging discusses the benefits of outsourcing some aspects of a business, so that one can better manage internal resources and concentrate on core competences.
As clinical trials become more global in nature, and outsourcing more common, pharmaceutical companies’ logistics needs are changing. Mark Paiz, president of Sherpa Clinical Packaging, explains how a specialist in CTM management services can provide the support they require, particularly in the field of temperature control.