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Bench scientists are looking for technologies to help them target their efforts on method execution, managing or eliminating deviations, and enhancing communication.
FREMONT, CA: When asked about the challenges that make them reconsider outsourcing work to bioanalytical Contract Research Organizations (CROs), pharmaceutical corporations are frank: 'regulatory compliance and scientific expertise,' as well as 'unresponsiveness and imprecise data'. This is not the message one wants to send to potential clients. Pharma sponsors must have high confidence in their CRO partners in a highly competitive market where compliance, quality, and integrity are crucial to winning and keeping business.
Meanwhile, early drug discovery and preclinical testing continue to be among the most time-consuming aspects of the drug development process. With only one out of every 5,000 molecules entering preclinical testing passing to clinical trials, stringent methods and skills are required to orchestrate these stages efficiently. This critical capability, which is both specialized and labor-intensive, is driving the present growth of the worldwide preclinical CRO market, which is predicted to reach 7.8 billion dollars by 2027, growing at an annual rate of 8.3 percent over the next seven years.
Over the expected growth period, bioanalytical CROs that can drive effective bioanalytical workflows, from sample preparation to analysis and auditing, would benefit the most. However, other aspects influence the value of CRO partners, and technology, particularly in the quality department, can help improve each of them.CROs have their own set of issues, including an increase in sample volume, a cost-conscious market, tight turnaround times, a growing range of assays, and the need to demonstrate regulatory compliance and establish a reputation. Simply put, they have run into a market-driven desire to accomplish more with less, faster, and more consistently.
Priorities fluctuate even more inside the CRO, depending on the observation point. Bench scientists are looking for technologies to help them target their efforts on method execution, managing or eliminating deviations, and enhancing communication. IT leaders naturally place a premium on digital transformation that has a measurable return on investment, especially when it comes to making better use of resources. And executive management is focused on the bottom line, looking for ways to reduce costs and increase yield while decreasing the need for more equipment or personnel. They would like to shorten project timelines and invoice more quickly.
A software-based strategy also realizes that people are not always the issue; they are a CRO's greatest asset. While it may appear that shifting the compliance load on humans and paper (or spreadsheets) requires the least amount of change management and investment, it cripples a research operation. As a result, the opposite of the planned effect occurs. Compared to what can be achieved in digital systems, pushing audit trail construction and Quality Control (QC) reporting directly influences sample throughput and introduces uncertainty. It is a rarely billable job, and it takes a long time.