From The Stage
← Back to From The Stage
Dr. Afshin Safavi
Posted by Dr. Afshin Safavi BioAgilytix Insight, Bioanalytical Lab Quality, CRO Selection

Where Expertise and Quality Converge: For CROs, One Isn’t Optimized without the Other

Where Expertise and Quality Converge: For CROs, One Isn’t Optimized without the Other

When pharma and biotech organizations look to work with a CRO or bioanalytical lab, quality is always among the top priorities. In fact, a recent Nice Insight survey on outsourcing trends in 2016 found that 70% of respondents agreed that quality is the most important driver when selecting a CRO to partner with.

But quality is not a single checkbox on the list of factors for CRO selection; rather, it is the collection of all attributes and capabilities that the CRO brings to the table, which enable quality to permeate the work they do. And for labs performing complex large molecule bioanalysis, expertise is a huge piece of the quality puzzle – but can be harder to come by than you may think.

This is because in the traditional CRO model, the scientific team assigned to a sponsor’s project is typically comprised largely of junior scientists who are led by a single seasoned scientist. The scientific leader delegates tasks and oversees analysis, but the majority of hands-on work is done by a team with minimal bench experience. These younger scientists simply have not yet had the experience of navigating many different types of scientific and regulatory challenges, and although they have a veteran team member providing oversight, it can be hard for that one person to catch every potential error.

That is why when it comes to ensuring high-quality bioanalysis with reliable results, BioAgilytix takes a different approach. We believe that the only way to maintain the standard of quality that our customers expect is by maintaining a ‘deep bench’ – a scientific team that has the breadth and depth of experience required to overcome bioanalytical complexities in any phase of development.

These are the attributes we bring as a bioanalytical lab partner to enable high quality:

Many Veteran Scientific Perspectives
Instead of using the traditional CRO model, which is heavily weighted with inexperienced staff, BioAgilytix fields an ‘A’ team for every project we undertake. We can do so because our scientific team averages 15+ years of bench experience, with over 35% PhD / Masters-level scientists. These team members each possess unique, real-world expertise that is specifically focused in large molecule bioanalysis, and each brings their own expert insights to benefit your study.

Having real experience in the stringent scientific and quality demands of biologics development gives our team the perspective to help you effectively navigate potential opportunities and pitfalls through every phase. The depth of skill that we can bring to a large molecule bioanalytical study is virtually unmatched, allowing us to deliver quality results with unequaled speed and success.

One Dedicated Team
A key part of quality that is often overlooked is team stability – an area where many traditional CROs are lacking. In fact, turnover rates continue to escalate, with a December 2015 survey showing the U.S. average jumping to 19.5%. This makes it difficult to maintain continuity throughout a project, particularly complex long-term studies, as scientists are continually shuffled in and out of the team.

BioAgilytix is also different in this respect, leading our industry with a 98%+ employee retention rate. Our team’s commitment helps ensure a seamless process for our customers, allowing them to collaborate closely with the same team from start to finish, and build strong relationships in a truly consultative, ‘scientist to scientist’ partnership.

All Roads Lead to Quality
With a proven, dedicated scientific team in place, BioAgilytix has a strong foundation for ensuring quality science and service. We then fortify that foundation with a sustainable Quality Management System (QMS) built upon four key pillars: customer understanding, performance and reliability, regulatory compliance, and ownership and accountability. The QMS provides guidance to our scientific experts for monitoring, measuring, and continually improving our quality practices.

It is obvious that quality is among the most critical indicators of bioanalytical CRO capability and performance. But as you can see, quality cannot simply be a check in a box – it must be assessed in line with the other factors that are integral to maintaining quality over time. At BioAgilytix, we understand that it takes an experienced, committed, and focused team to consistently ensure the integrity of bioanalytical results and the ability to meet pressing turnaround times.

Share This