Biospecimen collection, processing, and preservation have become critical elements in the conduct and management of clinical trials. In today’s competitive clinical environment, the components and usability of a study kit can have a significant impact on the acceptance and success of your clinical study.
ProMedDx has more than 20 years of experience in biospecimen collection studies, with unique expertise in optimizing studies through the design of protocol-specific study kits.
ProMedDx study kits emphasize ease-of-use and accountability, reduce user error and protocol deviations, and increase biospecimen accrual.
Protocol Specific Specimen Collection Kits
ProMedDx provides a cGMP-compliant environment for the manufacture and distribution of all of our specimen collection kits.
Our biological sample collection kits are custom-designed to meet the protocols of your specific clinical trial. Our team works with you to assess your specific sampling needs and to determine kit components based on the following:
- Study Design
- Date, duration, number of subjects, number of cohorts, number of visits, and other protocol-specific elements
- Matrices for Collection
- Whole blood, plasma, serum, fecal, urine, sputum, synovial fluid, FFPE, fresh frozen tissue, or cerebral spinal fluid
- Specimen Volume and Collection Time Points
- Investigative Site Considerations
- Technology Requirements
Specimen Handling Manuals
The success of your study hinges upon the study staff’s ability to utilize the study kits confidently and accurately. ProMedDx is experienced in the design of protocol-specific sampling, handling, and shipping manuals.
We can assist in the design of study requisition and accountability forms to ensure all documentation coincides with the protocol. Study-specific training materials to educate site personnel on proper collection, labeling, and shipping methods are also available upon request.
Study Kit Distribution and Tracking
ProMedDx works closely with you to schedule critical delivery time points for your biological sample study kits and related instructions – including study start-up, resupply, and close-out. We have a proven delivery track record and can ensure that your study kits will arrive at your investigative site at those critical delivery points – on time.
ProMedDx has shipped our specimen collection kits to 20 countries and are familiar with the regional specific shipping and import regulations. We have built reliable relationships with both domestic and international couriers to ensure on-time, smooth delivery of all specimen collection kits and/or bulk supplies.
Once your investigative site has collected the biological samples, ProMedDx guides them in scheduling and preparing their outbound shipments. We minimize the site’s paperwork (and potential errors) by providing pre-filled custom shipping labels and air bill documentation. Based on your specific requirements, the collected samples will be shipped back to you, to a testing laboratory, or to a biological specimen storage facility such as ProMedDx biostorage.
ProMedDx Study Kits Are a Clear Choice
There’s a reason why clinical study sponsors continue to include ProMedDx in the study design and kit supply of their studies: Their investigative sites prefer it.
With a 100% investigative site satisfaction rating, ProMedDx study kits are a clear choice. Want to ensure the accurate collection and proper handling of your valuable specimens? Leverage the customized ProMedDx study kit service for your next clinical study. Contact a BioSupply Project Manager.