Ethical, Legal and Compliant
iSpecimen’s innovative solution fully complies with HIPPA, the Common Rule, OHRP and FDA regulations. For more information about compliance and answers to the most common questions, please read our Frequently Asked Questions.
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The Future of Biospecimen Delivery
iSpecimen provides laboratories and hospitals a new way to make further, profitable use of their valuable clinical material while offering medical researchers with timely, high-quality and data-rich biospecimens for their research programs. We does this with our proprietary technology that links electronic medical records (EMRs) and clinical laboratory specimens at partner hospitals and laboratories to provide researchers with a steady supply of customized, annotated specimens.
While maintaining full legal and regulatory compliance, the iSpecimen solution retrieves desired samples from the millions of specimens that flow through clinical laboratories each day and intercepts these specimens prior to disposal if they meet defined criteria. This combination of a virtually unlimited supply of specimens along with robust patient data is accelerating the pace of research worldwide.
The iSpecimen technology integrates with hospital and lab IT infrastructure and consists of three main functions: Patient Cohort Selection, Medical and Lab Records Search and Biospecimen Processing and Delivery.
iSpecimen’s core technology links patient medical records to available laboratory discards, creating a steady supply of data-rich biospecimens for research
1. Patient Cohort Selection
When medical researchers require specimens, they make selections based upon search criteria such as gender, medical diagnoses and medications. iSpecimen’s technology manages these selection criteria along with study protocols to ensure that only studies that meet regulatory compliance and have IRB approval can initiate a biospecimen search.
2. Lab and Medical Records Search
iSpecimen’s technology consists of a clinical data repository and advanced analytical tools that track all available biospecimens and link them to their relevant medical data. This data may consist of simple clinical laboratory data all the way up to comprehensive, anonymized electronic medical records. When a request for samples is made, iSpecimen’s technology performs the search of available medical records to find matches and then checks for associated patient samples in clinical labs. All aspects of compliance including privacy (such as medical record de-identification) and research regulations are strictly enforced by the technology.
3. Biospecimen Processing and Delivery
When approved matches have been made, the iSpecimen technology generates a pick list for lab technicians and lets them know which specimens to select for research and which ones to discard. The selected specimens are carefully processed, packaged and delivered directly to the researchers or iSpecimen. De-identified and approved patient data is also made available to the researchers.