Packing and Shipping Instructions

SPECIMEN DROP OFF AT ONE PHARMA LAB

Study specimens can be delivered and dropped off at any One Pharma Lab Central Laboratory locations:

One Pharma Lab - Miami Central Laboratory

14261 Commerce Way

Miami Lakes, FL 33016

Drop off Hours:

Monday thru Friday - 8:30 a.m. – 6:30 p.m. EST

Saturday - 9:30 a.m. – 3:00 p.m. EST

Sunday – Closed


Specimens to be dropped must be in stable condition and free of brakeage or leakage.

Specimens must be individually packaged and properly labeled.

Safe ground transportation of specimens to and from laboratories is governed by regulation issued by the Department of Transportation (DOT) and the U.S. Postal Service (USPS). The DOT divides it’s regulations into nine classes, but labs are primarily concerned with Class 6.2 – Infectious Substances [1] and Class 9 – Miscellaneous [2] (which includes dry ice, often used for preservation).

When lab specimens are transported across a public street or highway they are covered by the DOT requirements. This means they must be boxed and labeled appropriately for a biological specimen (unless it meets the definition of infectious). Coolers with the biohazard label on them that are secured in the car (usually on the floor of the back seat) will meet those requirements.

ONE PHARMA LAB COURIER SERVICE

One Pharma Lab will provide courier service for specimens collected by the site. The site coordinator will call One Pharma Lab at 1 (844) 742-7621 email clinical.trials@1pharmalab.com once specimens are ready to be transported to the central laboratory.

Specimen pick-up(s) can be pre-scheduled in advance or can be set-up for daily scheduled pick-ups as needed by the study site.

Federal Express (FedEx) has been selected by Sponsor for the transport of your clinical laboratory samples for the trial. FedEx Express Next Day service, will be provided to sites that will require shipment of their samples overnight to the One Pharma Lab facility.

The SPONSOR FedEx account to use: XXXXXXXXX

A sample of the air bill can be found on the next page.

Web-site Address:

You can track your shipment by entering your airbill number on the following web site: www.fedex.com.

Note:

FedEx will not accept any shipment without the outer cardboard box.

One Pharma Lab supplies a FedEx Express UN3373 Pak at initiation for sites that will require shipment. If you need to replenish your supply of UN3373 Pak shippers, please contact your One Pharma Lab support associate or complete and fax the Supply Reorder Form.

For Friday Shipments:

- Mark “SATURDAY Delivery” (Attach Saturday Delivery Label)

Note: The FedEx pickup time should be determined the morning of each Subject visit. Contact Federal Express at 1-800-GO FEDEX (1-800-463-3339) for schedules and available pickup times specific for your area. Notify the Federal Express dispatcher that you require a pickup and provide the following information:

SPONSOR FedEx account to be used in section 7 of the airbill, bill to: Sender

FedEX Account: XXXXXXXX

Shipping To:

ONE PHARMA LAB

Attention: Central Processing

14261 Commerce Way

Miami Lakes, FL 33016

Tel: 1-844-742-7621