Quality First
Quality gives you confidence when you least expect it
Quality gives you confidence when you least expect it
Speed alone is not enough to get to market quickly. Quality and compliance are also paramount. Biorasi is committed to running studies that meet and exceed our partners’ expectations and regulatory requirements — from start to finish.
Most CROs think quality is a commodity — you won’t find a place for it on many of our competitors’ websites. At Biorasi, we see quality as a differentiator. Why? Because we are raising the bar in CRO quality and putting Quality First.
Our Quality First framework is built upon four quality cornerstones:
Audit Ready 24/7
Many organizations experience the nauseating mad rush to get into compliance when a regulatory audit is announced. You won’t find that experience here. Our goal is to ensure your study is always audit ready, whether we expect an inspection or not.
Real-Time Reporting
We think you should have access to data whenever you need it. Biorasi provides up-to-the-minute insight into KPIs, metrics, and other information as soon as it is recorded and available.
Transparency and Responsiveness
Worried your CRO knows about quality issues but hasn’t informed you yet? Never again. Biorasi’s commitment to transparency means that you know about our quality successes — and challenges — the minute that we do, so that we can address them as one team.
Holistic Study Oversight
Biorasi understands that we aren’t the only stakeholder leaving a mark on your study. That is why we go above and beyond the call of duty — identifying and tracking quality KPIs for all the third parties that we manage in the study as well; this means sites, labs, drug and device depots, and more.
Say yes to quality data
Quality Assurance is notorious for saying “NO.” After all, nothing can go wrong if nothing happens, right? Let’s throw that mentality out the window together. At Biorasi, we have built a Quality Team that is just as “Biorasian” as the rest of us, exhibiting the same relentlessly pioneering attitude, partner focus, and “One Team” mentality.
Our quality goal isn’t simply to do nothing wrong. This is the sort of mentality that traditional CROs use to justify inaction. Rather, our goal is to do more than anyone else, right, in the service of our partners.
We also say “YES” to:
ISO 9001:2015 certification
The international standard for quality and regulatory requirements, because we see value in third-party validation that our services consistently meet the requirements and expectations of our customers.
Ongoing process improvement
Utilizing methodologies such as Kaizen and Continuous Improvement, because we appreciate that a better way is always yet to be discovered.
Quality Control (QC) checks
Quality control in harmony with QA to help ensure quality at the point of creation, because we understand most errors are better fixed on the spot.
Quality tells the story
Biorasi’s QA team is with you every step of the way. Discover how our Quality department identified study risks and issues in real time, and worked with our partners to keep their studies moving smoothly throughout the entire study life-cycle.
