Due to the inherent complexity of large molecule bioanalysis projects, choosing the right partner to support your study from the start is the most important step. A lack of seasoned expertise can result in costly setbacks, including delayed timelines, overrun budgets, and inadequate results. But knowledge alone is not always enough to deliver reliable assays within set timeframes; the CRO also has to have the capacity and technology needed to support efficient turnaround times and accurate, reproducible data.
Let’s take a look at some of the key attributes to look for when selecting a bioanalytical lab partner:
The Right Combination of Expertise and Technology
Essentially, your large molecule project cannot be successful without a team that can address a wide array of bioanalytical challenges, because when it comes to this type of study, complexities are bound to arise. Look for a CRO that maintains a high level of scientific expertise within the organization by maintaining a “deep bench” – an entire scientific team that has a breadth and depth of real-world experience, and proven track record of effectively addressing obstacles at any phase of development.
The CRO should obviously have deep expertise in the area of your assay focus, but it is also helpful to assess their capabilities in related large molecule areas, such as work they have done in biosimilars, immunogenicity, PK, cell-based assays, and biomarkers. Often this breadth of experience can also benefit your study, as the scientists can apply learnings from related projects to optimize your specific assay.
The right expertise will help minimize timeline lag because problems can be solved efficiently, but combining this insight with advanced bioanalytical technology can accelerate the study’s success even further. A CRO that can leverage advanced platforms and automation tools will be able to deliver robust results more rapidly by condensing the time it takes to actually run the assays, and with the systems providing confidence that the results are precise and reproducible.
A Commitment to Quality in Every Capacity
How can you determine is your CRO partner is committed to quality? The facility is a key outward-facing indicator of the caliber of bioanalytical testing that is conducted there, so look for a state-of-the-art facility with the capacity and equipment to handle your complex project. Quality can also be measured by adherence to GxP guidelines, which your CRO partner should follow. When a facility is committed to meeting these regulatory requirements, you will not only receive quality results, but also streamline regulatory approval periods with data that has been gathered from the start in accordance with agency recommendations.
This focus on quality should permeate every project the CRO touches, from small discovery studies to large sample analysis projects required for Phase III trials. It is important that your chosen partner has the capacity – in physical space and also in instrumentation and high level scientific staff – to support your study as it progresses, with the same level of quality at each phase. Ideally your partner can handle your project end-to-end, so that you don’t have to deal with the potential data compromises or delays of switching CROs midway through the study.
Time and Budget Consciousness
We have discussed the importance of leading technology, breadth of expertise and dedication to quality. The final component on your CRO checklist is a time- and budget-conscious partner. Consistent timelines and working within budget go hand-in-hand. A slipping timeline inevitably leads to an out of scope budget; thus an ideal CRO partner will be committed to producing reliable, high-quality results within a reasonable turnaround time.
When choosing a partner, look for one that uses a proven, well-planned project management approach that includes a high level of continuity among the project team. Transparency is also critical to ensure your study stays on track, so focus on labs that encourage collaboration and openness throughout the process.
The Right Partner Creates Successful Projects
At BioAgilytix, our expert scientific team works tirelessly to make sure your project avoids each possible pitfall of the drug development process, by proactively addressing each bioanalytical challenge before it becomes an expensive issue. We understand that nothing is more frustrating or harmful to the success of your drug development project than delayed turnaround or lack of expertise threatening your ability to bring life-changing biotherapeutics to the patients you serve. As such, we only work with the most talented bioanalytical scientists to efficiently carry out your project through all phases of development.
Learn more about how BioAgilytix can be your right-fit CRO partner by speaking to one of our scientists about our capabilities and areas of expertise today.