Outsourcing used to be done for mostly “non-critical products/services,” but the last 20 years have seen a reversal in this trend. More and more companies are outsourcing key critical Good X Practices (GxP)- regulated Contract processes and products manufacturing. To improve efficiency and increase productivity, reliance on Contract Manufacturing Organizations and Contract Research Organizations continues to increase.
When selecting service providers, according to a recent survey, sponsoring pharma companies stated that they focus on the following criteria (listed in order of importance). Respondents described the following as “very important”: Confidentiality (81%); Quality (81%); Consistency of performance (79%); cGMP compliance (75%); Regulatory inspection history (69%); timeliness (60%); contract firm’s financial stability (56%); and project cost (54%). Pharmaceutical company sponsors are outsourcing more functions so that they can focus on their core strengths.
Similarly, a third of clinical trials conducted by pharmaceutical firms are outsourced to vendors, with 70% of pharma companies expecting an increase of outsourcing to CROs.
However, the selection of clinical CROs seems more focused on matching chemistry, ie, that they can work with the CRO (63%); followed by the perception of dedication (62%); experience in the same indication (61%); and CRO overall experience in the study’s therapeutic area, but hardly any weight is given to Good Clinical Practice or Good Pharmacovigilance Practice compliance.
The way a pharmaceutical company contracts CROs/CMOs has a critical and direct impact on a company’s realization of its goals. Many collaborations have ended with catastrophic outcomes with shock-waves impacting all stakeholders, including the patients. In another survey, nearly half (45.6%) of responding pharma companies stated that they had quality problems resulting from vendors, poor product quality, poor service quality, inexperience with regulatory requirements, and 49.1% of vendors made promises they could not keep.
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