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Clinical Trial Services

Therapak offers over 10 years of experience in medical and laboratory kit assembly and shipping services. In the pharmaceutical clinical trials market, Therapak management has been involved in the assembly and shipping of visit specific kits to investigator sites worldwide. Clinical trial testing laboratories such as MedTox Laboratories and Quest Diagnostics have utilized Therapak for lab kit preparation and distribution.

Protocol Management for Clinical Trial Studies

Therapak's Clinical Trial Services for managing a particular study are governed by a Master Services Agreement (MSA) and subsequent Work Orders for each protocol. The MSA is coordinated between the customer and Therapak's Director of Business Development. Once the MSA and corresponding Confidentiality agreements are in place, the scope of work for each protocol is reviewed by the Business Development Director so that a Work Order or Fee Schedule can be proposed. The Work Order includes Protocol set up fees and other charges associated with the design, development and management depending on the realm of services performed by Therapak.

The Director of Business Development will assign a Project Manager to each study once the initial scope of services and fees for the services is agreed on by both parties. The Project Manager will manage all remaining aspects of setting up the study and processing the study according to the agreed upon requirements. The Project Manager will initiate a New Protocol Notification form for each study and send that to the Project Leader at your company so that important information is gathered and sent back to Therapak's Project Manager to commence the services. Then, the Project Leader will electronically fill out Kit Definition forms and transmit those files to Therapak's Project Manager to identify all of the visits within a protocol and the content of supplies in each kit and any supplemental or bulk supplies that will also be sent to each site.

Therapak's Project Manager will then create bill of materials, work instructions and quality control documentation for the study as timelines progress toward the anticipated site shipping dates. Site shipment request forms are prepared for all shipments by the Project Leader and sent to Therapak's Project Manager as supplies are required at the sites. In some cases, automatic resupply programs will be part of the scope of services governing the schedule for reorders according to the visit schedule.

For specific fees concerning an upcoming study, please contact the Director of Business Development, Clinical Trial Services to discuss your requirements.

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VSK™ (Visit Specific Kit) Assembly and Site Distribution

Clinical Trial Studies usually involve the development of Visit Specific Kits (VSK's™) that will be sent to an Investigator site on a scheduled basis. Therapak is the leading outsourcing partner that will help you design, develop and distribute VSK's™ according to cGMP (Current Good Manufacturing Practices) quality system requirements.

Therapak's Project Managers are experienced individuals who have managed and processed clinical trial studies for biotechnology firms, commercial clinical trial testing laboratories and pharmaceutical companies worldwide. Overall, Therapak is very familiar with troubleshooting protocols to help clients develop a visit based schedule for lab kits that serve the purpose of monitoring patients involved in a clinical study on an investigational drug.

Beyond managing the VSK™ development process, Therapak typically governs all aspects of shipping the kits to the investigator sites throughout the study as a distribution function. The VSK's™ and all associated bulk supplies, requisitions, airbills, dangerous goods documentation and shipping supplies are coordinated at Therapak by the assigned Project Manager and shipped to the site. As patients show up according to the visit schedule, specimens are packaged and shipped directly to the designated testing facility that performs the lab work and results reporting for the study.

KitAs a GMP production facility, Therapak offers turnkey services for the procurement of finished medical devices, inventory, manufacturing, storage and distribution of customized visit specific kits for the biotechnology and pharmaceutical industry.

Therapak stocks hundreds of products for use in the assembly of clinical trial kits. From transport boxes to evacuated blood tubes to cryogenic tubes to labeling, Therapak has the experience and understands the timelines necessary to assist in the management of clinical trial kit packaging and site distribution.

KitWhether you have visit oriented kits, pharmacokinetic timepoint specific kit or bulk supplies, Therapak can help you customize site-friendly packaging for outbound and inbound shipping. All kit components are heat sealed in a polybag to protect the integrity of the components. Whether the kit is in a box or presented in the bag to the site, protocol labels identifying the Sponsor name, part number, visit description, timepoint, lot number and expiration date are developed by Therapak and applied to the bag or box as specified. Multiple visit or timepoint kits can also be packaged in large dispenser boxes for easy use at the collection site.

Feel free to call on Therapak for your next clinical study.

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Pharmacokinetic (PK), PD and other Phase I TSK's™ (Time Point Specific Kits)

Therapak is experienced in assembling and distributing PK, PD and other Phase I type Time Point Specific Kits (TSK's™), requisitions, labels and bulk supplies. Protocol development involving these types of kits follows the same quality oriented set up under the guidance of Therapak's Director of Business Development and Project Managers.

Whether the study requires bulk supplies and preprinted sheet labels for managing the collections by time point or TSK's™ that consist of a heat sealed bag of supplies and labels for each time point collection, Therapak can assemble materials to your requirements and distribute those materials directly to the investigator site.

For more information, contact the Director of Business Development, Clinical Trial Services.

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Bulk Supplies Packaging and Site Distribution

Clinical studies requiring bulk supplies shipments can be accommodated by Therapak. Protocols that call for bulk supply of evacuated blood tubes (Vacutainer brand collection tubes), cryogenic vials, transfer pipets, sheet stock patient identification labels and Fedex shipping supplies can be combined for investigator site shipment from Therapak. In many cases, clients require specific shipping materials or shipping systems, cryogenic storage boxes, refrigerant packs, instructions sheets and CRF's to be sent to sites as ancillary items. These are recognized at Therapak as bulk supplies or supplemental supplies.

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Customer Supplied Products and Temperature Sensitive Storage/Shipping

If your protocol includes bulk supplies along with VSK's™ or TSK's™, Therapak has a method of controlling these items so that each site receives the required kits and bulk supplies according to the visit schedule. Customer supplied items are also a common request and although storage and handling fees are applied to these items, Therapak will receive and inspect these items and store them until the time of shipment. For temperature sensitive products supplied by clients to Therapak to hold until the time of shipment, monitored - room temperature, refrigerated and frozen storage is available. Therapak stocks refrigerant packs and insulated coolers for shipping temperature sensitive items to sites. Dry ice is readily available for shipping frozen products to sites as well.

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Frozen Specimen Shipping Products for Site Distribution

Therapak inventories five sizes of insulated coolers, three sizes of polyurethane coolers (for International shipments - long haul), shipping cartons, dry ice labels, biohazard labels, IATA dangerous goods labels and refrigerant packs. The combination of these products provides clients with all of the necessary shipping materials and regulatory labeling needed for sites to prepare frozen specimens for shipment to a testing laboratory. These products can be sent as bulk supplies to each site according to the visit schedule for each protocol.

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Diagnostic Specimen Shipping Systems

Therapak is an industry leader in providing a full range of Diagnostic Specimen Shipping Systems. For protocols involving the shipment of Diagnostic Specimens, Therapak can integrate its Diagnostic shipping components into VSK and TSK configurations or provide stand alone, complete shipping systems as bulk supply items so that a site has everything they need to ship specimens back to a testing laboratory in compliance with the latest DOT and IATA shipping regulations. Therapak's Diagnostic Shipping Systems feature 95kPa certified secondary containment products (specimen shipping bags and canisters), absorbent materials and other packaging with appropriate labeling for ambient, refrigerated and frozen Diagnostic Specimen shipping. There are 18 stock shipping systems available from Therapak to meet all of your protocol shipping requirements for Diagnostic Specimens.

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Infectious Specimen Shipping Systems

Therapak offers a myriad of solutions for clinical trial studies requiring Infectious Specimen Shipping Systems. All systems have been independently tested and certified to comply with applicable UN regulations, DOT regulations and ICAO/IATA Packing Instructions 602 and 904. Therapak can integrate any of the Infectious shipping systems located in the laboratory products catalog section of the therapak.com website to meet your protocol requirements. These systems include shipping materials for ambient, refrigerated and frozen specimens.

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Customized Requisition Form Design and Printing

For your convenience, Therapak can assist in the design and printing of your study requisition forms customized for your protocol needs. By reviewing the specific protocol requirements, Therapak can prepare a customized form either from a set of predefined templates or from a client provided sample with specific field design requirements. Throughout the entire process the client is involved in the various review and approval processes to ensure that the forms adequately capture the necessary information and that it corresponds with the CRF and analytical laboratory systems. Therapak will also prepare pre-printed site specific requisition forms by merging the approved requisition templates with your investigator database. To assist with your printing needs, forms can be printed in various NCR parts, colors and formats. Since most Visit Specific Kits (VSKs™) require a visit and site specific requisition to be enclosed, Therapak can help reduce your transport and printing costs by eliminating the need for you to print forms separately and pay to have them shipped to Therapak for distributing to your sites along with the VSKs™.

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Bar Code Label Development and Printing

Therapak will work with you and your vendors to develop customized bar code labels for your project needs and to ensure that all of your barcoding and labeling needs are satisfied. As your study setup partner, Therapak can prepare customized bar code labels in any barcode format and label size to meet your study needs. By reviewing your protocol or project needs, Therapak can make suggestions as to the various barcode systems that you can take advantage of to ensure easy labeling and identification of your study tubes and forms. Patient specific barcode systems can be created by using randomized numbers or by using pre-assigned numbers generated from your information management system. Therapak is also capable of producing aliquot specific labels to be used for your pharmacokinetic studies and other projects that require the generation of timed multiple splits.

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Courier Services for Clinical Trial Study Samples

Therapak teams up with Quickstat to provide courier services for clinical trial study samples that require transport from an investigator site to a testing laboratory. Therapak frequently provides a turnkey approach to protocols where clients prefer single sourcing of a variety of services including courier activity. Therapak's preferred QuickSTAT rates offer customers the ability to contract the courier services for a protocol to Therapak. In this scenario, Therapak will manage the pick-up of samples from an investigator site and track shipments of samples on an electronic basis until the samples are signed for at the destination. For more information, contact the Director of Business Development at Therapak.

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