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Dr. Afshin Safavi
Posted by Dr. Afshin Safavi BioAgilytix Insight, Bioanalytical Lab Quality, CRO Selection

In Bioanalysis, Timing is Everything: Can Your CRO Keep Up with Your Innovation Demands?

In Bioanalysis, Timing is Everything:  Can Your CRO Keep Up with Your Innovation Demands?

A 2015 survey from ISR Reports found that among the top metrics evaluated by sponsors when selecting a bioanalytical lab partner were turnaround time and on-time data and report delivery. This is logical in today’s fast-paced world of pharma and biotech innovation, where missed deadlines and timeline creep can not only compromise a competitive advantage, but delay the release of life-saving biologics to the market. And while a 2016 NiceInsight survey found that 50% of sponsor respondents said they would actually switch CROs based on lack of on-time delivery, the reality is that our field is still overwrought with projects that routinely run behind schedule and over budget due to poor execution, miscommunication, and improper planning.

Combating this issue requires a rethinking of the traditional project management approaches typically employed by CROs. Oftentimes, the veteran scientists that the customer meets in the kick-off phases of their bioanalytical project are not the ones actually overseeing the day-to-day work. The project is handed off largely to junior scientists with comparatively less bench experience, while being expected to maintain the same high levels of speed and quality that the veteran team would provide. Less experience inherently brings more risk, and the junior scientists are more likely to run into challenges or make errors that can create major project delays—especially when facing the technical and regulatory complexities of large molecule bioanalysis. There is also the common practice among traditional CROs to shuffle projects in the schedule as new, bigger studies come in, pushing back the smaller work and expanding their timelines in the process.

At BioAgilytix, we manage projects differently. Our customers expect their project to be orchestrated effectively, delivering results that are of high quality, on time and on budget. And we recognize that there are many pieces that need to align to produce these results, based on the scientific, budgetary, and time restraints set. Here’s how we make it happen:

Every Project is a Priority Project
The complexity of large molecule assays demands continuity, and we prioritize every project to ensure both team and scheduling consistency within its demanded timeline. Our deep bench of expertise gives us the flexibility to run a multitude of projects in tandem at the highest levels of quality, without compromise. Our ‘A’ team of scientists is not pulled off in-process projects to advance larger, higher-profile studies when they come in, because we have other ‘A’-level scientists that we can assign instead. Every assay we perform gets the same expert attention and oversight from start to finish.

A Single Point of Contact, Start to (On-Time) Finish
One of the main reasons studies fall behind schedule when working with traditional CROs is a lack of communication. Conversely, BioAgilytix’s quality and customer service has been consistently ranked #1 in our industry—and this achievement is due in large part to our unique, differentiated project management model. Each and every project we touch is led and managed by a Bioanalytical Project Manager (BPM)—a scientist with deep experience in both bioanalysis and project management. BPMs help to mitigate the risk of poor communication slowing down a project’s timeline by actively overseeing each study both in and out of the lab, and actively collaborating with our customers’ own scientific teams as a consistent, single point of contact throughout the project. Our BPMs synchronize and prioritize every phase of the project from beginning to end, ensuring we are able to complete complex projects on even very tight timelines.

Through our differentiated approach, BioAgilytix helps our customers avoid the pitfalls of project reprioritizing, timeline delays, and scope creep that occur all too often in traditional CROs. We are committed to delivering each and every project on time, on budget, and with the highest quality results—and we’ve proven our ability to do this time and again for our customers. Our team combines highly specialized expertise in regulated bioanalysis, veteran insights, and innovative technology to accelerate your biologic candidate’s success through every phase of development – compressing your timeline from discovery to market, and exceeding your quality expectations along the way.

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