1: Can I use your samples in our clinical trials?
2: Do you qualify your investigator sites?
3: Are your CRAs responsible for monitoring ProMedDx sponsored clinical trials certified?
4: Has ProMedDx, LLC been audited by the FDA?
5: How does ProMedDx ensure quality?
6: How does ProMedDx ensure that our order will be delivered in good condition?
7: How do you monitor the temperature of specimens stored at your facility?
8: What do you do in the event of a power failure?
9: Our collection site is/will be shipping Infectious Biologicals to your company, is this legal?
10: What is the format of your barcodes?
11: How do you print your barcode labels?
12: What size are your labels?
13: Can you create a custom label or barcode for my samples?
14: How do you perform Data Entry?
15: What type of database server do you use?
16: What type of technology platforms do you use?
17: Is your data backed up?
18: What formats do you supply sample data in?
19: Can you provide data in a custom format?
1: Can I use your samples in our clinical trials?
Yes. All of our specimens are collected under IRB approved protocols by qualified Investigator sites. These sites conduct our studies according to 21 CFR, ICH/GCP guidelines and HIPAA Privacy Regulations. Informed Consent is obtained from every subject, unless this requirement has been determined by the IRB to not apply and has been waived. You can be assured that if you use any of our specimens in your clinical trial or 510K submission that these specimens have been collected in accordance to the applicable FDA regulations.
2: Do you qualify your investigator sites?
Yes. Our investigator sites are qualified according to our own internal standard operating procedures. Our sites include Reference Laboratories, Blood Centers, Universities, Hospitals, Medical Centers, and Private Practice Physician Offices. These sites are trained to operate in accordance with ICH/GCP guidelines, 21 CFR, and HIPAA Privacy Regulations. ProMedDx monitors and performs on-site audits of investigator sites for compliance to ensure that our specimens and data are of the highest quality and integrity.
3: Are your CRAs responsible for monitoring ProMedDx sponsored clinical trials certified?
Yes. All CRAs are certified with at least 2 years of monitoring experience. These CRAs are responsible for all site initiation, interim monitoring, and study close-out activities at our investigator sites.
4: Has ProMedDx, LLC been audited by the FDA?
Yes. In the seven years that ProMedDx has been registered as a blood establishment with the FDA, we have been successfully audited by the FDA on several occasions. We have never received one observation or 483.
5: How does ProMedDx ensure quality?
ProMedDx utilizes its own Standard Operating Procedures (SOPs) to ensure consistency and quality to all the products and services we provide. ProMedDx has an established Quality Department responsible for maintaining review and approval of all internal procedures. The Quality Department is also responsible for performing internal audits of all current ProMedDx operations. This ensures that we are following our own established SOPs and are in compliance with all applicable cGMP regulations.
6: How does ProMedDx ensure that our order will be delivered in good condition?
All of our packaging used for the shipment of biological materials is certified for the highest thermal quality. Each shipment within North America is packaged with 10 - 20 kgs of dry ice and all International shipments are packaged using a minimum of 30 kgs of dry ice. These amounts have proven to be more than adequate to ensure the minimum temperature thresholds established even when delays are encountered.
7: How do you monitor the temperature of specimens stored at your facility?
Temperatures are monitored 24 hours a day, seven days a week using a state of the art wireless monitoring system. In the event a unit enters the alarm state, the monitoring system will notify the predetermined contact list, via phone and email. Upon resolving the issue, the system requires the operator to enter an electronic signature and comment, prior to clearing the alarm state.
8: What do you do in the event of a power failure?
We don’t lose power often but hurricanes, snow storms, and car accidents do happen that can affect the power to our building. To protect our specimen inventory and information systems we maintain a diesel powered generator that automatically supplies emergency power to the building within seconds of a power outage. The generator is tied directly into the buildings state of the art security system and will cause alarms in the event of low fuel or a generator failure. Our servers are backed by heavy duty battery UPS to provide uninterrupted power during the lag between generator start up and a power failure.
9: Our collection site is/will be shipping Infectious Biologicals to your company, is this legal?
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 supply training to all personnel involved in the packaging and shipment of these materials prior to the initial shipment and are always available to assist with any additional questions which may arise.
10: What is the format of your barcodes?
We use two barcode symbologies: CODE 39 and Code 128. The barcode itself consists of a 1-20 numeric identification number unique to each sample. We are currently transitioning away from the CODE 39 barcode symbology, in favor of the more robust CODE 128.
11: How do you print your barcode labels?
We are currently transitioning from a laser printed label system to thermal transfer labels. Laser labels are provided in set form and thermal transfer labels are provided in perforated roll form. We use Zebra thermal printers for thermal transfer labels.
12: What size are your labels?
Our standard sample label size is a customized 1.25” by 1.25” as this fits best on a 2 ml cryovial. Our label stock is validated for long term storage in -190 (Celsius) conditions. We do provide other label sizes and formats to clients who have specific requirements including cap labels and larger label sizes.
13: Can you create a custom label or barcode for my samples?
Yes. Contact your account representative and they will work with our I.T. department to meet any of your custom label or bar coding needs.
14: How do you perform Data Entry?
The data points for the majority of our collections are entered using an electronic import, followed by a data entry QC into our inventory management system. We also perform direct double data entry for samples that electronic data imports are not available for.
15: What type of database server do you use?
Our inventory management systems have been designed to using the Microsoft SQL Server database engine. We currently use Microsoft SQL Server 2005 exclusively for all data access requirements.
16: What type of technology platforms do you use?
We use the Microsoft technology platform. Our internal software systems are developed using Microsoft .NET technologies and target the Microsoft SQL Server database engine. We operate a few Linux servers for specialized tasks.
Yes. We perform a full backup of our network nightly to DLT tape and store the media in a fireproof safe. On a weekly basis we ship tapes by courier off-site to Iron Mountain for safe and secure vaulted storage. Our databases are backed up throughout the day to ensure that we can restore transactions in the event of a mid day failure and are also backed up in full on a nightly basis.
18: What formats do you supply sample data in?
Our standard inventory report and data sheets are supplied in Microsoft Excel format.
19: Can you provide data in a custom format?
Yes. Contact your account manager and they will work with our I.T. department to meet your custom data formatting needs.