Clinical Trial Services
Therapak offers over 10 years of experience in providing supply chain logistics solutions for the pharmaceutical and laboratory industries. In the Clinical Trials market, Therapak has been involved in the assembly and distribution of custom visit specific kits to investigator sites worldwide. Clinical Trial Central Laboratories, Diagnostics Reference Laboratories, CROs, in addition to many Pharmaceutical and Biotech companies utilize Therapak for their clinical kit preparation and distribution needs on a regular basis.
Protocol Management for Clinical Trial Studies
Therapak's Clinical Trial Services are governed by a Master Services Agreement (MSA) and subsequent Work Orders for each protocol. Once the Confidentiality Disclosure Agreement (CDA) is in place, and concurrent with the review of the MSA, the protocol or project supply requirements are reviewed by Business Development so that a Scope of Work proposal (Work Order) can be prepared. The Work Order lists all the clinical supplies and services that will be provided for each protocol along with a Bill of Materials breakdown for each unique kit type. Typical components accounted for on a Work Order will include the necessary specimen collection kits, ancillary bulk supplies, sample shipping supplies, chemical reagents, and any print material such as tube labels, requisition forms, lab manuals, airway bills and any other custom documents.
All customers are assigned a dedicated Therapak Project Manager for each protocol once the initial scope of services is agreed on by both parties. Our skilled Project Managers will manage all remaining aspects of setting up the study and work closely with client's clinical team to process the study according to the agreed upon requirements and protocol launch timelines. Among other things, Therapak's Project Manager will create all of the necessary production documentation for each kit style, prepare tube label templates for customer's review and approval, and set-up the protocol in Therapak's proprietary online ordering system called CT-Online for managing and tracking all aspects of site supply orders.
Please contact firstname.lastname@example.org to discuss the clinical supply needs for your upcoming study.
Therapak's state of the art online supply management portal called CT-Online gives sponsors and laboratories secure web based access to:
Please contact email@example.com to discuss the clinical supply needs for your upcoming study.
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.
As 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.
Whether 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 packaged in a sealed bag 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.
Pharmacokinetic (PK), PD and other early Phase TSK's™ (Time Point Specific Kits)
Therapak is experienced in assembling and distributing PK, PD and other early phase protocol 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 Business Development and Project Management team.
Whether the study requires bulk supplies and preprinted sheet labels for managing the collections by time point, or TSK's™ that consist of nominal timepoint sub-kits packaged together in a larger visit box, Therapak can assemble materials to your requirements and distribute those materials directly to the investigator site.
or more information, please either send an inquiry to firstname.lastname@example.org, or contact us at (626) 357-5900 and ask for Clinical Trial Services.
Bulk Ancillary 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 ancillary supplies or supplemental supplies.
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.
Frozen Specimen Shipping Products for Site Distribution
Therapak inventories many stock sizes of insulated EPS and 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, or organized in a kit presentation as explained under Biological Substance Shipping Systems section below.
Biological Substance Shipping Systems
Therapak is an industry leader in providing a full range of Biological Substance Category B and Exempt Human Shipping Systems. Therapak can integrate its shipping components into specimen collection kit 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 Shipping Systems feature all the components necessary for compliant packaging of the specimens such as 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. For convenience, you can either select from Therapak's large selection of stock shipping systems available in our online catalogue, or specify a custom configuration that also incorporates your protocol shipping requirements.
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. These systems include shipping materials for ambient, refrigerated and frozen specimens.
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™. In certain laboratory applications where appropriate, Therapak can also access customer's LIMS or Clinical Trials Management System to print requisition forms and tube labels from customer systems.
Bar Code Label Development and Printing
Therapak will work with you and your vendors to develop customized bar code cryolabels 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 various barcode formats and label sizes 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. Based on specific customer requirement, Therapak can either pre-apply the cryolabels to the tubes at the time of kit assembly, or include them in the kit for the site coordinator to apply at the time of specimen collection.
Courier Services for Clinical Trial Study Samples
Therapak works with all major national and specialized courier service providers to help coordinate the outbound shipment of clinical supplies to investigator sites worldwide. Please contact us if you need assistance coordinating your outbound shipment of supplies to the sites, or inbound shipment of clinical samples from the site to the testing facility.
Therapak's Quality Management System has been developed in compliance with regulatory standards to meet the needs of our global customer base and to improve the management practices of our company. The quality system operates in accordance to the United States Food and Drug Administration's current Good Manufacturing Practices for medical devices - 21 CFR § 820; Singapore HSA's TS-01 - Good Distribution Practices for Medical Devices and Good Assembly Practices; and Article 12 of Council Directive 93/42/EEC concerning medical devices, commonly referred to as the Medical Device Directive (MDD).