Bioanalytical studies are an essential aspect of biologic drug development that may necessitate outsourcing bioanalysis experts.
FREMONT, CA: The analysis of biological samples for drugs in a regulated environment is vital in nearly every drug development program. The toxicological and clinical programs that need bioanalytical help are critical to establishing the drug's safety and efficacy and can involve many analyses spanning multiple species, studies, and years. In a pharmaceutical R&D environment, where multiple drugs are in several stages of development, management of the logistics, costs, and science involved with this process can be a daunting task. Outsourcing bioanalytical work to contract research organizations has become an essential strategy for pharmaceutical firms. Here is more to know.
Firms considering outsourcing are well-advised considering how an outsourcing partnership with a CRO can match up respective vital competencies. CROs themselves should be aware of this and strive to develop and offer their clients capabilities that complement the existing in-house potentials.
Across the pharmaceutical sector, there will be a spectrum of in-house resources depending on the firm's size and associated business strategy and philosophy. So there is no one size fits all bioanalytical outsourcing model for a CRO and sponsor to implement. Rather, finding and matching potentials is a key element of establishing the optimum outsourcing partnership.
Lack of proper equipment is a vital inducement to outsourcing. A CRO may have improved sample handling equipment, specialized equipment, and new equipment, offering opportunities for faster, seamless analyses or instruments with higher sensitivity. This is again a situation where a CRO can save a firm's time by offering faster method development or obviate the requirement to bring in and master new technology with all its related investments. Some small or specialty pharmaceutical firms have become concerned with their potential to meet the regulatory needs using in-house staff and potentials. They are thus looking to CROs for more analyses than they might have previously. The attraction of outsourcing all the GLP work to an experienced CRO with capacity is often a persuading factor for pharma companies.