Insights

Learn more about how Versiti leukopak products are collected following formal quality systems that result in reduced variability and risk.

In September 2022, the FDA announced a Notice for Proposed Rule Making (NPRM) titled Institutional Review Boards; Cooperative Research. Want to learn more? Review pertinent information regarding this proposed rule and its potential impact in Salus IRB's newest guidance document.

Explore how Versiti Clinical Trials can provide efficient and quality diagnostic testing services for complex, large-scale projects, empowering clients with the critical data needed to make informed decisions.

Whether you’re a multinational pharmaceutical giant or a smaller pharma or biotech company, navigating intricate logistics and regulations in multicenter, global clinical trials can be daunting. Learn more about how Cenetron can help to enhance operations, provide quality assurance and ensure client satisfaction.

Learn more about how Versiti’s consultative approach and partnership with a client established a process for a recallable and usable contributor bank to provide quality starting materials for manufacturing in this case highlight.

Navigating the regulatory and compliance guidelines for source materials like leukopaks or other human blood products for the emerging cell therapy market involves having a clear understanding of your research goals. Download Versiti’s whitepaper discussing regulatory considerations in selecting the right biomaterial product.

The increasing cost and complexity of clinical trials demand an innovative partner to help guide a trial through every phase, every day. Download our white paper to see how Versiti Clinical Trials can help.

With significant growth in the cellular therapy market projected over the next 4-6 years, several limiting factors, including the high cost of leukapheresis and stringent donor recruitment criteria for leukopak collections pose a unique set of challenges for companies without significant experience in the space.

Digital elements of clinical trials like electronic medical records, wearable devices, and digital sensors and apps have all previously been employed as supplements to traditional data collection. Before COVID-19, the demand for the kind of technology needed to support virtual clinical trials was much lower. Digital alternatives to in-person appointments, testing, and check-ins experienced a sudden demand increase due to the pandemic and have caused digital clinical trials to accelerate at an unprecedented speed.

Did you know that in clinical settings, diagnostic testing errors are the most prevalent type of malpractice claim? Advances in automation, sample collection, transport and data reporting have reduced the frequency of these errors to less than 10%. But how do you reduce the remaining 90% of errors that occur outside the clinical laboratory?

New quality concerns from the U.S. government lay bare the risks of choosing a for-profit IRB. Can for-profit IRBs serve as a human subject safety net, responsible for protecting the hundreds of thousands of people who enroll in clinical trials each year? Non-profit IRBs, like Salus, represent a compelling alternative for businesses in search of a solution.