ASPiRA IVD is dedicated to meeting the unique testing needs of IVD manufacturers commercializing high-complexity assays. With an emphasis on delivering accurate and reliable results suitable for FDA submission, ASPiRA IVD is built around a core of laboratory expertise and a FDA-compliant quality system. ASPiRA IVD’s experienced project teams and a highly-flexible LIS enable custom solutions for each and every client.
To learn more about ASPiRA IVD and our offerings, please email [email protected].
With most CROs focusing on pharma, biotech and medical device industries, IVD manufacturers are forced to deal with the larger commercial labs to provide testing in support of the IVD studies and trials. But everything about a large commercial laboratory revolves around providing clinical testing for patients creating a range of problems/issues as patient testing takes priority over “research” testing for IVD trials and studies.
ASPiRA IVD was built for the sole purpose of meeting the needs of IVD manufacturers seeking to commercialize complex diagnostics. Our custom solutions approach is designed to address the unique problems associated with IVD clinical trials and studies while streamlining the entire process from project estimates and contracting all the way through to the delivery of a locked study database.
Rapid Estimates & Contracting
ASPiRA IVD’s experienced team will be able to quickly evaluate your project providing timely and accurate estimates. Our streamlined contracting process allows for rapid project start up.
Site Initiation and Training
Our laboratory professionals and pathologists are ready to be trained at your earliest opportunity for rapid site initiation. To provide the best available pathologist training and case review environment, ASPiRA IVD custom-built an area for pathologists to convene for training purposes with state of the art high-definition display.
Site Visits & Audits
Easily schedule necessary site visits with ASPiRA IVD. Our services and team are dedicated to clinical studies & trials, unlike the larger clinical labs. We not only expect these important quality assurance activities, but welcome the opportunity to introduce the ASPiRA IVD team and show you our facility and procedures.
LIS & Data Management
ASPiRA IVD uses the award-winning LIS System WindoPath* offered by Psyche, providing the ultimate in flexibility to accommodate sponsor-designed requisitions/reports. WindoPath’s modular, highly-customizable design allows for the efficient transfer of study data.
ASPiRA IVD has five board-certified pathologists each with decades of IHC experience. In fact, our entire team of laboratory professionals has an average of 25+ years of industry experience. Our pathologists include experts in a broad range of fields with sub-specialization in:
- Breast Pathology
- GI Pathology
- GYN Pathology
Of course, our most important staff member for any clinical study is our laboratory director and principal investigator, Dr. Mary Lachman. Dr. Lachman is triple-boarded in anatomic /clinical pathology and cytopathology. See below for more information:
Mary Lachman, M.D.
Laboratory Director/Principal Investigator
Dr. Lachman received her medical degree from, and finished a residency in anatomic pathology at, the University of Toledo Medical School in Toledo, OH. She then completed fellowships in both surgical pathology and cytopathology at Hartford Hospital in Hartford, CT. Upon completion of her fellowships, Dr. Lachman became Director of Cytopathology at Yale University School of Medicine. In 1995, she joined DIANON Systems as Director of Gynecological Pathology and later assumed additional roles as Director of Cytopathology and Associate Laboratory Director at DIANON/LabCorp. Dr. Lachman is a member of the College of American Pathologists.
Most other laboratory service providers will make claims about their quality. But ASPiRA IVD has a unique advantage over all other laboratory providers. Since our parent company is Vermillion, ASPiRA IVD’s rigorous quality program begins with the QMS for an IVD manufacturer. Building upon Vermillion’s QMS as a foundation, ASPiRA IVD’s quality program includes additional components to meet the requirements for laboratory testing and clinical research.
- Fully comply with CLIA, FDA and GLP/GCP standards
- In accordance with ISO 15189:2012
- Oriented towards test accuracy