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FREQUENTLY ASKED
QUESTIONS
Select the topic below to explore the questions.
Frequently Asked Questions
Clinical Trial Testing Support
Getting Started
How can I get my samples tested?
How can I obtain a pricing bid for sample testing?
Does BioPharma Diagnostics review my protocol to advise me on the appropriate tests to order?
Does BioPharma Diagnostics return residual samples after testing?
Ordering and Results
Will BioPharma Diagnostics complete and return a data transfer specification?
Can I get electronic data transfers? What formats does BioPharma Diagnostics support?
Can my testing be expedited?
How do I order testing? How will I get results?
Does BioPharma Diagnostics guarantee the published turnaround time (TAT) that is described in the Test Catalog?
Can BioPharma Diagnostics flag the reports for my inclusion and exclusion criteria? If my reference ranges are unique, can my reference ranges be specified in the reports?
Can I get a real-time list of the samples that BioPharma Diagnostics receives?
Preparing Specimens
Does BioPharma Diagnostics approve out-of-stability testing?
Can I use my clinical account to send in samples?
How should I label my specimens? Does BioPharma Diagnostics require patient name, gender, and birthdate? What should I specify for these fields when I am unable to provide this information?
What address should I send the samples to?
Can I send plasma such as serum or EDTA instead of the requested specimen?
Transporting Specimens
Can I order tests and ship samples on holidays and weekends?
Where should I send my samples?
Does BioPharma Diagnostics facilitate specimen shipments?
Supplies
Does BioPharma Diagnostics provide supplies, such as tubes, kits, and shipping containers? Where can I get them?
Billing
How do I pay for the tests that I order?
How do I access Invoices?
Quality
Can I visit your facility for regular audits during the project?
Is the BioPharma Diagnostics staff trained in Good Clinical Practice (GCP) and if so, how often? Could you provide a summary of required training for your staff?
What are the requirements for collecting and preparing my specimen?
Research Collaborations
Contracting
Can a collaboration agreement and lab services agreement be combined?
What is the process for setting up a contract with Mayo Clinic?
How long will it take to set up my project?
Analytical Validation
Can instruments be brought into the Mayo labs for my project?
Institutional Review Board (IRB)
Is the BioPharma Diagnostics staff required to have human subjects protection training?
Is the Mayo Clinic IRB fully accredited?
Can an external IRB be used?
How often does the Mayo IRB meet for projects that require full board review?
What is the turnaround time for IRB review?
Data & Monitoring
How will project data be provided or transferred to me?
Sponsored Testing
Getting Started
What is sponsored testing?
How does a sponsored testing program benefit patients and health care providers?
Which health care providers have access to the sponsored testing program?
How does a sponsored testing program benefit the pharma company?
What is the process to set up a sponsored testing program?
What data can the sponsoring pharma company receive as part of the program?
COVID-19
COVID-19 Clinical Trial Testing
Since BioPharma Diagnostics uses a common code for COVID-19 testing, can I direct my samples for testing to a specific platform? Or will the samples be tested by a mix of platforms?
Does BioPharma Diagnostics offer a test for COVID-19 viral load?
Can I obtain cycle threshold (Ct) values with the results?
What antibody type is measured? What is the antibody directed toward?
Does BioPharma Diagnostics offer a quantitative serology test?
What other serology tests are available?
Other Testing Questions
Is cytokine storm testing available?
Where can I find a list of all available COVID-19 tests?
Where can I find information about stability, TAT, specimen type, and specimen volume for a specific test?
Can samples that are non-validated sample type or out of stability be sent for testing?