The rapidly changing bioanalytical industry can make it challenging for contract research organizations (CROs) to keep up with the technology demands of the sponsors they serve. However, where there are challenges, there are also great opportunities to add value to a study by bringing in the right platform at the right time. Organizations that establish strong sponsor partnerships, and that are also open to improving their current platforms based on sponsors’ unique study requirements and current market innovations, will be in the best position to deliver new value through new technology – here’s why:
It Helps Align Priorities that Drive Platform Selection
As a CRO, we work with a wide variety of sponsor companies. As such, we see substantial variation when it comes to customer priorities and what they need to get out of a platform for a given study. Depending on the company, the target, and the project itself, requirements can be vastly different. This is why we value and seek out platforms that offer high levels of robustness, because a platform that can produce reproducible result can sustain a long-term clinical trial that may last years, and gives our scientists more flexibility how it can be leveraged through the phases of development.
But, it is essential to keep in mind that while robustness may be most relevant to one sponsor, another may prioritize sensitivity or the ability to use low volume samples as the most sought-after platform feature. By working closely with the sponsor to understand their short- and long-term study needs upfront, CROs can determine early what kind of platform functionality will be needed, identify if their current technology suite can support those requirements, and plan ahead for integration if new instrumentation must be brought in.
It Builds Value on Both Sides
Having a strong understanding of a client’s needs for a given study is important, but in order to move beyond just a transactional relationship with a sponsor – one where the CRO adds little value to the project – the CRO needs to engage them as a partner. Pharmaceutical and biotechnology companies have begun to view outsourcing differently than even a decade ago, and are finding that access to external specialty expertise can be a strategic advantage. They are now looking to establish true partnerships with their outsourced providers, and this shift can benefit the CRO greatly as well, especially when justifying new technology investments. For example, a sponsor may require a new platform that the CRO does not yet have, and implementing it may not bring the CRO short-term ROI, but if the sponsor is committed to running more projects on that platform with the CRO in the future, it is easy to justify the technology’s long-term value.
In addition to sponsor’s changing perspectives on outsourced partnerships, we’ve also found that who we work with on the sponsor side has changed, also to the CRO’s advantage. Around 2008, there was a major shakeup in the pharmaceutical industry due to external economic factors, and many scientists with deep knowledge and expertise in the later stages of their careers moved into procurement roles. This shift in personnel has made a significant impact in how we as a CRO work with our customers, because now we are talking directly to people who truly understand the science behind what we are doing. This makes our partnerships more strategic, as we can work closely together to best plan for each project, using our collective expertise to determine what platforms to leverage, when, and how.
It Mitigates Risk of Inconsistency
New and improved platforms are constantly being introduced to the market. It may be tempting to implement the latest and greatest technology as it becomes available, but a change in instrument mid-project could have a negative impact on consistency and, ultimately, study results. That is why it is generally not best to change to a brand new technology in the midst of an ongoing study; however, it is valuable to consider implementing new automation features or other improvements to the existing platform being used as the study progresses. While it is necessary to be cautious in this area, it is good for CROs to be flexible and seek opportunities to improve upon the platforms they do have, as it can enable them to deliver more value to the sponsor without added risk.
Learn more about how BioAgilytix assesses opportunities to invest in new technologies in the full-length Business of Bioanalysis panel discussion from WRIB 2018, featuring BioAgilytix’s Founder & Global CSO, Afshin Safavi, Ph.D.