BioIVT Introduces New Quality Management System to Maintain Highest Quality Biospecimens and Drug Development Research Services

WESTBURY, NY, US - Oct 16, 2018 - BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced that it is introducing a new internal cloud-based Quality Management System (QMS), Master Control. This new standardized, ISO compliant QMS will help BioIVT manage documentation, auditing, supplier and customer accounts, and risk across all locations. It will consolidate and replace a variety of computer- and paper-based document control systems located at existing and newly-acquired BioIVT sites in the US, Europe and Asia.

“BioIVT’s mission is to consistently provide our customers with the highest quality biospecimens and research services to advance drug development. As BioIVT continues to grow rapidly, both organically and through acquisitions, it was important to invest in this high caliber, quality infrastructure to ensure that we maintain consistency in our quality processes across all our sites,” said BioIVT Chief Executive Officer Jeffrey Gatz.

BioIVT has acquired five companies since August 2017 - Asterand Bioscience, Qualyst Transporter Solutions, Optivia Biotechnology, Ascendance Biotechnology, and Clinical Trials Laboratory Services.

This new QMS, Master Control, which will tie into BioIVT’s customer relationship management and enterprise resource planning systems, will provide easier oversight of the company’s quality management and training programs. For example, the QMS, Master Control will assign training automatically when documents relevant to an employee are revised. Supervisors will be notified automatically if any of their employees are missing training. In addition, the system will allow online training, including subject matter exams, to be implemented as necessary. As a result, it will help to ensure consistent training across BioIVT sites for similar job functions.

Underscoring its commitment to maintaining the highest quality and ethical standards regarding the use of biospecimens in life sciences research, BioIVT will be co-hosting a one-hour webinar entitled "Gaining Clarity: Ethical and Regulatory Considerations and Common Misconceptions in the Use of Human Biospecimens” at 11 a.m. ET on Oct. 25.

This webinar will be co-presented by WIRB-Copernicus Group (WCG) Chief Compliance Officer David Forster JD, MA, CIP, and BioIVT Director of Product Marketing, Personalized Medicine Cathie Miller, PhD. WCG, the world's leading provider of clinical trial optimization solutions, is responsible for the ethical and regulatory oversight of 90% of the world’s research. WCG serves as the Institutional Review Board (IRB) of record for more than 2,700 academic medical centers, hospitals and universities, and administers more than 700 local Institutional Biosafety Committees (IBCs), helping to ensure the scientific integrity and regulatory compliance of the research conducted at these institutions.

Mr. Forster and Dr. Miller will discuss several pertinent ethics and compliance issues regarding the procurement and use of human biospecimens for life science research. For example, how do you appropriately compensate/reimburse donors? How do FDA and HHS-sponsored research regulations differ? Under what circumstances can non-consented biospecimens be used for research? How do you ensure ethical collection of biospecimens outside the US?

Interested parties can register for this complimentary event at https://info.bioivt.com/ethical-regulatory-considerations-registration.

About BioIVT

BioIVT, formerly BioreclamationIVT, is a leading global provider of research models and value-added research services for drug discovery and development. We specialize in control and disease-state biospecimens including human and animal tissues, cell products, blood and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research and the effort to improve patient outcomes by coupling comprehensive clinical data with donor samples. Our PHASEZERO® Research Services team works collaboratively with clients to provide target and biomarker validation, phenotypic assays to characterize novel therapeutics, clinical assay development and in vitro hepatic modeling solutions. And as the premier supplier of ADME-toxicology model systems, including hepatocytes and subcellular fractions, BioIVT enables scientists to better understand the pharmacokinetics and drug metabolism of newly-discovered compounds and their effects on disease processes. By combining our technical expertise, exceptional customer service, and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in elevating science. For more information, please visit www.bioivt.com or follow the company on Twitter @BioIVT.