Insights & Publications
The increasing cost and complexity of clinical trials demand an innovative partner to help guide a trial through every phase, every day. Versiti has 75 years of expertise in blood health innovation, making new ideas and innovative approaches accessible to our clinical trial partners. Explore our insights below.
Ultra-High Throughput (UHTP) Assay Development: Utilizing the Nexar™ PCR Platform for COVID Testing
Quantigen, with the Gates Foundation, developed a scalable, cost-effective COVID-19 testing solution using dry swab collection and the Nexar™ UHTP PCR platform. This innovation secured FDA EUA and set new standards for diagnostics and pandemic response.
Case Study, Medical and Scientific Writing
A new biopharmaceutical company asked Pearl to help prepare reports and manuscripts for submission in support of a new product approval and launch.
Case Study: Regulatory, Quality Compliance, and CMC Analytical Services
Discover our general quality compliance services, pivotal clinical trial support, regulatory strategy, and filing support for a small pharmaceutical company.
Case Study: Study Startup in the U.S. for a European Sponsor
An EU-based CRO was working with a sponsor to set up a trial in Europe when the sponsor expressed interest in expanding the trial into Australia and the US.
Customized Starting Materials for Manufacturing: Client Highlight
Versiti supports a client with a therapeutic in phase 1 clinical trials sought to identify and maintain a unique contributor pool eligible to support future manufacturing and commercialization.
FDA’s Proposed Rule for IRBs on Cooperative Research
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.
Filling the Leukopak Gap
Versiti added the provision of leukopak products to support emerging cellular therapy research. Our established leukopak contributor bank operates under an IRB-governed protocol,ensuring both the contributor experience and resulting blood products meet strict quality and regulatory standards.
Fundamental Trust: Not for Sale
Commercial IRBs oversee 70% of all US. clinical trials now – does this present a quality concern for the ethical protection of human subjects in research?
Reducing Pre- and Post-Analytical Errors
Pre- and post-analytical errors, which occur before and after the laboratory has processed a specimen, account for 90% of sample errors.
Case Study: Optimizing Sample Logistics for Global Clinical Trials
Cenetron and a multinational pharmaceutical corporation engaged in a project to streamline sample logistics for global clinical trials. This collaboration ensures enhanced trial efficiency, maintained quality and compliance, and increased client satisfaction.
Risk Making for INDs
Oftentimes, academic and office-based researchers wish to study an approved drug in a slightly new way.
Selecting the Right Biomaterial Product: Regulatory Considerations and Terminology in Leukopak Collections
Read about the regulatory requirements in selecting the right leukopak product.
Trends and Insights in IRB Warning Letters
The number of warning letters sent to IRBs from the FDA has shown a steady increase over the past five years, the majority of which have been given to institutional IRBs. We explain the reasons behind this and how to navigate the regulatory framework.
Types of in Vitro Diagnostics: Clearing up the Confusion
All IVDs for use are medical devices, however, it's easy to get lost in in the language of acronyms – ASRs, RUOs, and more. Clear up the confusion in this whitepaper.
VCT Case Highlight: HLA Diagnostic Testing Services
Versiti Clinical Trials partnered with a large biopharmaceutical company to provide HLA typing services in support of a clinical trial project. Find out more.
What Could Proposed Changes to the Common Rule Mean to Sites, Sponsors and IRBs?
Summary of changes to the US Department of HHS Common Rule.
Quality Counts: Expertise-driven, High-yield Cell Collections for Leukopaks
Learn more about how Versiti leukopak products are collected following formal quality systems that result in reduced variability and risk.
Estoteric Testing Services
Utilize Versiti's cutting-edge diagnostic technologies to drive advancements in in-vitro diagnostics
Excellence Backed by Accreditation
Explore Versiti Clinical Trial Services’ and affiliates’ accreditations and certifications that highlight our commitment to quality, compliance and regulatory excellence.
Biomarker Development & Validation
Versiti Clinical Trial Services offers end-to-end biomarker development and validation services, empowering translational research and personalized medicine advancements.