Clinical trial testing support FAQ

Getting started

Getting started


How can i get my samples tested

A sample testing project begins with the following steps:

  • BioPharma Diagnostics creates a pricing bid and sends it to you for your review.
  • Your study team approves the pricing bid.
  • We provide you with a customized laboratory service agreement that outlines the responsibilities or obligations of each party and includes the legal requirements.
  • The legal teams review the contract.
  • We set up your project-specific research account. Account setup typically takes two to four business days.
  • After the contract is signed and the account is set up, you can send your samples to us for testing.

How can i obtain a pricing bid for sample testing

To request a pricing bid, you will need to provide the following information:

  • If possible, provide the Mayo test ID as found in our Test Catalog.
  • Number of samples to be tested for each test ID.
  • Expected timeline for submitting samples for each test ID.
  • If samples are currently in storage, provide the following information:
    • Type of specimen
    • Age of oldest specimen to be tested
    • Temperature at which specimens have been stored
    • Type of tube
    • Indicate whether samples have undergone any freeze-thaw cycles
  • Name of institution or company that will be contracting with Mayo if a contract is signed.

How Does biopharma diagnostics review my protocol to advise me on the appropriate tests to order?

To determine the appropriate testing, you can compare your protocol requirements and project specifications with our tests as described in our test catalog. If you have questions about specific tests, you can provide the Mayo test ID to your project manager, who will gather additional information from the testing lab.


How Does biopharma diagnostics return residual samples after testing?

Residual samples are not routinely returned. However, you can discuss exception requests with your project manager.

Ordering and results


Will BioPharma Diagnostics complete and return a data transfer specification?

The laboratory services agreement details how results will be provided. We do not use data transfer agreements or specifications, because we do not provide data management services typically associated with clinical trials.

Authorized users can access test data and download results through the MayoLINK ordering system, when MayoLINK is used for test ordering.


Can I get electronic data transfers? What formats does BioPharma Diagnostics support?

Electronic data transfer is not currently supported. If orders are placed through the MayoLINK ordering system, test results can be viewed online or downloaded. For manually placed orders, results are transmitted via facsimile (fax).


Can my testing be expedited?

BioPharma Diagnostics treats all samples with equal importance and is unable to expedite specific samples. Upon receipt, all samples are accessioned and sent to the lab.


How do I order testing? How will I get results?

You can order tests through the MayoLINK online ordering system. When orders are placed in MayoLINK, results are delivered through the MayoLINK system and can be downloaded as PDF, JPG, TIF, PNG, TXT, or CSV files. You will be notified by email when results are available. All paperwork needed for accessioning your sample is provided through MayoLINK. A requisition form and label with the required information for sample intake and testing can be printed.

You can also order tests manually. Specimens can be submitted with completed requisition forms or manifests. Samples are manually accessioned at our facility. Results are returned via facsimile (fax).

Note: Result reports will contain specimen information as provided when orders are placed. Data management services are not provided by BioPharma Diagnostics.


Does BioPharma Diagnostics guarantee the published turnaround time that is described in the Test Catalog?

We adhere to the published turnaround time whenever possible. However, sometimes extenuating circumstances, such as equipment malfunctions or other issues beyond our control, can result in a turnaround time that is longer than expected. In these situations, you will be contacted as soon as possible.


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?

Customized flagging and reference ranges are not currently supported.


Can I get a real-time list of the samples that BioPharma Diagnostics receives?

Shipment deliveries can be tracked by using your courier tracking number. If orders are placed through the MayoLINK ordering system, you can track individual specimens from receipt through testing and resulting within the MayoLINK system. For manually placed orders, specimen tracking is not available. Separate sample receipt reports are not supported.

Preparing specimens


Does BioPharma Diagnostics approve out-of-stability testing?

Sample stability is discussed at the beginning of each project. Samples that are outside of the published stability parameters must be approved by the laboratory director before they can be accepted for testing.


Can I use my clinical account to send in samples?

Clinical accounts are used only for clinical diagnostic testing. A separate research account is recommended for sending in research samples. After the laboratory director approves your testing to ensure that it meets stability, labeling, processing, and billing specifications, the research account is created.


How should I label my specimens? Does BioPharma Diagnostics require patient name, gender, and birth date? What should I specify for these fields when I am unable to provide this information?

The specimen label must include two identifiers that exactly match what is ordered in MayoLINK or what is displayed on your requisition or shipping manifest. You can use your subject ID as one of the identifiers and a sample number as the other identifier. BioPharma Diagnostics staff will work with you on matching the identifiers and completing the required fields. In many cases, de-identified data can be used in place of PHI.


What address should I send the samples to?

The shipping address and contact information will be provided to you after the contract is finalized.


Can I send plasma such as serum or EDTA instead of the requested specimen?

With approval from the performing lab director and supervisor, substituted specimen types can be accepted.

transporting specimens


Can I order tests and ship samples on holidays and weekends?

Mayo Clinic Laboratories is open 24/7/365. However, individual carriers might be closed and might not make deliveries on recognized holidays. The following holidays are observed in the United States:

  • New Year’s Day: January 1
  • Memorial Day: Last Monday in May
  • Independence Day: July 4
  • Labor Day: First Monday in September
  • Thanksgiving Day: Fourth Thursday in November
  • Christmas Day: December 25

Note: Contact your preferred carrier for local holiday information.


Where should I send my samples?

You will send samples to Mayo Clinic Laboratories after a contract has been finalized and your account setup has been completed. The shipping address and contact information will be provided to you at that time.


Does BioPharma Diagnostics facilitate specimen shipments?

You are responsible for the shipment of specimens to Mayo Clinic Laboratories. For information about CDC or transportation requirements, refer to CDC Permits or Transportation Regulations.

Supplies


Does BioPharma Diagnostics provide supplies, such as tubes, kits, and shipping containers? Where can I get them?

If the test catalog indicates that supplies are provided for a specific test, then you can submit a request to your project manager at BioPharma Diagnostics. You will need to specify the supply number described on the Specimen tab for the specific test in the test catalog (e.g., T465). In addition, you will need to provide the quantity of supplies needed, your client account number, and your shipping address.

To order supplies for collecting and shipping test specimens to Mayo Clinic Laboratories:

Billing


How do I pay for the tests that I order?

Payment options include check, automated clearing house (ACH) bank transfer, or credit card.


How do I access Invoices?

Invoices are typically available at the beginning of each month and show charges for testing that was performed the previous month in addition to any pending balances from previous months. Email notifications are sent to your billing representative when invoices are available.

To access invoices, sign in to mayocliniclabs.com.

Quality


Can I visit your facility for regular audits during the project?

BioPharma Diagnostics permits a site qualification visit, which includes a tour of our facility and review of standard operating procedures. However, we do not allow routine audit monitoring visits, where we would pull records for your specific study.


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?

Our training is based on College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) requirements rather than GCP, and all employees complete annual competency assessments with seven required elements:

  • Direct observation of test performance/employee duties (e.g., specimen handling, processing, and testing).
  • Direct observation of performance of instrument maintenance and function checks.
  • Observation for compliance with safety protocols.
  • Assessment and evaluation of problem-solving skills.
  • Assessment of test performance.
  • Monitoring, recording, and reporting of test results.
  • Review of intermediate test results and work product records for compliance with SOPs and applicable work load limits.

What are the requirements for collecting and preparing my specimen?

For general requirements, refer to Instructions by Specimen Type.

For specific requirements, search for a test in the Test Catalog and refer to the Specimen and Performance pages for that specific test. Special Instructions and Forms are also available on the Specimen page when applicable.

If no specific collection and preparation instructions are provided by Mayo Clinic Laboratories, refer to manufacturer or regulatory guidelines.