Quality & Regulatory
ProMedDx is committed to the protection of patient privacy and applies processes and technology to ensure that Protected Health Information (PHI) remains secure and is not released without patient consent. Protection begins at site initiation, where our team trains study staff and partners on our de-identification procedures. Two additional levels of privacy protection are implemented upon the arrival of the specimens and data at ProMedDx: the investigative site is coded and the individual specimens and data are assigned and labeled with a new unique identifier prior to registration into The BioRepository and/or distribution to a lab.
ProMedDx utilizes our own stringent standard operating procedures (SOPs) to maintain the consistency and quality of all the specimens that we provide – from collection to storage to delivery. ProMedDx has an established Quality Department that is responsible for the ongoing review and approval of all internal procedures. Our Quality Department also is responsible for performing audits of all current ProMedDx operations to ensure that we are following our own established SOPs and are in compliance with all applicable cGMPs.
Yes. All CRAs that are responsible for monitoring ProMedDx-sponsored clinical trials are certified with at least two years of monitoring experience. These CRAs are responsible for all site initiation, interim monitoring, and study close-out activities at our investigator sites.
ProMedDx, LLC is an FDA-registered blood establishment. We are audited by the FDA every two years. ProMedDx has never received an FDA Form 483.
Our investigator sites are qualified according to our own internal standard operating procedures (SOPs). Our sites include reference laboratories, blood centers, universities, hospitals, medical centers, surgical centers, and private practice physician offices. These sites are trained to operate in accordance with IRB, ICH, and GCP guidelines and FDA and HIPAA regulations. ProMedDx monitors and performs ongoing onsite audits of investigator sites for compliance to ensure that our specimens and data are of the highest quality and integrity.
Monitoring & Storage
Temperatures are monitored continuously by our 21 CFR Part 11-compliant centralized monitoring system (CMS). The system is networked utilizing 418 MHz wireless sensors installed within each storage unit. Critical temperature limits are established in the monitoring system for each unit, and in the event a unit exceeds a limit, the system will notify our predetermined emergency contacts via phone, email, and text so that the issue can be corrected immediately.
We don’t lose power often, but hurricanes, snow storms, and other natural disasters can occur and can affect the power to our building. To protect our valuable specimen inventory and data systems, a standby diesel-powered generator supplies reliable emergency power to our building automatically and within seconds of a power interruption – even in the most demanding conditions – in order to maintain critical temperatures for all of the specimens in The BioRepository and biostorage units in our facility. Our backup power solution is tested and maintained regularly by certified experts through our support contract with the equipment manufacturer.
Collection & Use
Of course. ProMedDx accelerates your research from discovery to diagnosis and supports all phases of your research with viable, high-quality biospecimens that comply with strict industry regulations. All of our biospecimens are collected under IRB-approved protocols by qualified investigator sites. These sites conduct our studies according to ICH and GCP guidelines, 21 CFR 50-, 54-, and 56-compliant protocols, and HIPAA regulations. Informed consent is obtained from every subject, unless this requirement has been determined by the IRB that informed consent does not apply and has been waived. If you use any of our specimens in your scientific research or marketing clearance or approval applications, you can be assured that these specimens have been collected in accordance with the applicable FDA regulations.
Yes. Among our many services, ProMedDx expertly manages the collection of biospecimens that meet the specific requirements of your research. We conduct these collections professionally and ensure informed consent and compliance with guidelines including IRB, ICH, and GCP as well as Title 21 of the Code of Federal Regulations (CFR) and HIPAA regulations through our network of ProMedDx-approved and trained investigator sites around the globe.
Yes. ProMedDx not only manages the precise collection of specimens that meet your specific research requirements, we also offer bioprocessing and storage services for your collections. Following our own strict standard operating procedures (SOPs), we divide collected materials into smaller parts and store them at appropriate temperatures to ensure that your biologics are viable, repeatable, and available for all phases of your research through clinical trials.
Shipment & Delivery
The BioRepository contains thousands of clinically annotated, IRB-approved biospecimens that are available to ship to your lab as soon as the next day. Our expert project managers will work with you to identify specimens from The BioRepository that fit your requirements for in-vitro diagnostics, pharmaceutical/biotech, and clinical research. ProMedDx can ship biospecimens to your destination anywhere in the US as well as internationally. To date, our products have been shipped to 21 different countries worldwide.
The ProMedDx logistics team ships more than 4,000 temperature-controlled containers annually. Each order begins with source-to-destination evaluation of weather, distance, and customs/transportation considerations – then is scheduled for shipment. On the day of shipment, specimens are transferred from our storage and placed carefully within the appropriate certified insulated shipping containers based on outside temperature/weather and time-to-delivery. Each shipment within North America is packaged with 10-20kg of dry ice; each international shipment is packaged using a minimum of 30kg of dry ice. Each shipping container is labeled with the required content and handling labels and assigned a courier airbill. Once a shipment has left the ProMedDx dock, a notification is sent to the recipient. The ProMedDx logistics team closely monitors the transport of the shipment through its arrival at the destination.
Yes. During start-up, we supply all of the proper packaging and supplies required to comply with the most current IATA standards for the shipment of biological materials. In addition, we provide training to all personnel involved in the packaging and shipment of these materials prior to the initial shipment. Further, the ProMedDx team of experts is available to assist with any additional questions that may arise.
Our proprietary inventory management systems are custom-designed specifically for ProMedDx unique purposes and procedures. We utilize the Microsoft SQL Server database engine.
ProMedDx is on the Microsoft technology platform. Our internal software systems are custom-developed using the Microsoft .NET framework. Our inventory management and specimen tracking software target a Microsoft SQL Server database.
Yes. Our database and servers are backed up in 15-minute increments to an internal storage device that performs nightly uploads to a cloud backup solution. Our internal servers are virtualized on two physical servers for redundancy resulting in 24/7/365 uptime and availability.
Our systems accept all commercially available barcode symbologies. The standard barcode types used by ProMedDx are Code 39 and Code 128. Our technology specialists can work with your team to validate any system-specific symbologies that are required.
Yes. Contact your ProMedDx account representative who will work with our IT department to meet any of your custom label or barcoding needs.
The data points for the majority of our collections are entered using an electronic import into our custom-designed inventory management system (PIMS™). We also perform direct double-data entry for those samples that do not have electronic data available. Every data point entered into PIMS is validated through automated quality control procedures by a series of independent verifications.
We can supply data in any requested format. If a specific format is not requested, our inventory report and data sheets are supplied as Microsoft Excel (.xls or .xlsx) files.
ProMedDx clients include leading global organizations in the pharmaceutical/biotech, in-vitro, and clinical research industries. ProMedDx biologics and services are at work behind the scenes of many significant discoveries and diagnoses. Our company and our supporting work is referenced in medical publications and literature, many of which can be viewed on this site in our Resource Center.