Pharmaceutical companies face enormous challenges. It’s difficult to imagine running a business that is more complex than an innovative pharmaceutical company. Setting aside for a moment whether or not a company should be vertically integrated and the regulatory hurdles that must be overcome in our complex world, the basic challenge of generating chemical or biological entities to meet an unmet medical need is enormous. Our customers must de-convolute the complex biochemical interactions that underpin the effectiveness and safety of a drug candidate, completely characterize its chemical and physical structure, ensure its safety, create a large-scale manufacturing process and distribute to the four corners of the world. Can you imagine trying to build a laptop if we didn’t even know for sure if the component parts would connect, let alone how the electrical circuit would perform when they were assembled? No other business proposition is as complex as that faced by the modern pharmaceutical industry.
As the clinical trial process continues its reign under the microscope of scrutiny, companies are starting to realise the true power of transparency – a weapon that can
Quality by design and design space are concepts that have been around for quite some time in the pharmaceutical industry. Slowly the industry has warmed up to these concepts. Since the authorities provided the industry with guidelines, the interest has increased even more. The vision of filing a design space is ambitious and may feel overwhelming when first proposed. However, over the years more and more knowledge has accumulated and the industry seems ready to take the next step. When taking this step a frequently asked question is: “How do we report the DoE part of a design space document internally as well as to the authorities?” In design space projects different departments are commonly involved. Therefore a standard operating procedure (SOP) to avoid errors due to misunderstandings is necessary.
PRA, a leading global clinical research organization (CRO), conducts clinical trials in more than 80 countries across six continents through our 38 global offices. PRA provides outsourced clinical services for all therapeutic areas across all phases of pharmaceutical and biotech drug development. As a full-service CRO, PRA offers a broad array of services encompassing the entire spectrum of clinical development programs, from filing of Investigational New Drug and similar applications to product registration and post-marketing surveillance.