Strategic and Operational Services for
Clinical Packaging and Supplies
Medpace has a dedicated Clinical Packaging and Supplies department (CP&S) to assist Sponsors with the complexities of providing timely and compliant Investigational Product throughout clinical studies from taking the lead or supporting management of Investigational Product, based on specific Sponsor requirements. Below is a highlight of the key services offered:
|Vendor, supply, and inventory management
|Depot set-up and management
|Initial and resupply strategies
|Internal and external IRT collaboration
|IRT specifications and User Acceptance Testing
|Supply chain management
|Label development and packaging
CP&S Key Services
Vendor, Supply, and Inventory Management
Medpace has a network of pre-qualified vendors for compounds in any stage of development. We can support and/or manage: API manufacture; Bulk manufacture; Primary packaging; Secondary packaging and labeling; Pre- and Post-production documents review; Product release and storage; Shipment to depots and sites; Reconciliation, returns, and destruction.
CP&S can develop, manage, and coordinate timelines within and across Medpace, the Sponsor, and the vendor. CP&S can develop and manage timelines to include efficiencies by implementing concurrency where applicable, rather than sequential, and to meet global, regional, and/or local requirements, in conjunction with other functional areas.
Initial and Resupply Strategies
Based on study timelines, country approval dates, site initiation schedules, and enrollment projections, CP&S can develop and implement a depot set-up strategy including Import Licenses, Importer of Record, timelines, and appropriate quantities of Investigational Product. CP&S can manage and maintain depot inventory to ensure product availability throughout study conduct.
Realizing that excessive or limited shipments, along with depot inventory excesses or shortages, are preventable with continued tracking, CP&S can optimize shipments and inventory levels at depots and sites.
Internal and External IRT Collaboration to
Develop IRT Specifications and User Acceptance Testing
CP&S can collaborate with ClinTrak IRT® for inventory management at depots and sites; timing and quantity of initial and resupply shipments; use-by date management; product disposition; temperature excursions; subject dosing; reconciliation, returns, and destruction.
Because many clinical studies are conducted with concurrent stability programs, and knowing that use-by dates are printed on global labels, CP&S is an active participant in understanding the stability program, including stability test dates with the goal of maximizing use-by date, while minimizing date extension labelling activities, and/or product waste.
Supply Chain Management
Working in collaboration with the study start-up team, CP&S develops, plans, implements, and manages Investigational Product supply chain activities to insure timely and compliant product availability including label development, approval for compilation into Regulatory submissions.
Labels are where the IP timeline is made or broken
Medpace can develop labels to insure maximum compliance and ease of use, whether product is dispensed on site, or for take home use, Labels are where the IP timeline is made or broken. Medpace can develop a complete global booklet label for maximal inventory usage, thereby avoiding regional or single panel labels, with resultant inventory limitations.
Sponsor Benefits – Clinical Packaging & Supplies
Sponsors’ studies of any size can benefit from working with Medpace Clinical Packaging & Supplies.
CP&S works within the Medpace full-service CRO model. This differs from the CRO business model, in that the CP&S role is often provided piecemeal by several internal departments, or by full out-sourcing. This is particularly beneficial for small to mid-size biotech and biopharma companies as Sponsors can rely on Medpace for “one-stop shopping.”
CP&S works with a global network to insure operational activities are coordinated to meet first patient first dose date. CP&S develops a unique tripartite relationship between Medpace, Sponsor, and Vendor, with open communication and collaboration, ensuring study timelines and deliverables are met. With clearly defined roles and responsibilities, potential gaps and/or duplications are eliminated. As an internal Medpace function, CP&S provides a consolidated and unified approach to study start-up, recruitment, treatment, and close-out.
CP&S is skilled at managing multiple, concurrent and sequential documents, tasks, and processes, in a complex technical and regulatory environment. As part of the Medpace organization, CP&S prides itself in doing its part to make the complex seamless.
For more information, contact us.
Fact Sheet- Clinical Packaging and Supplies
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Making the Complex Seamless® with CP&S Services
CP&S makes the complex seamless by supporting the Medpace mission, to accelerate the global development and approval of safe and effective medical therapeutics. CP&S does this by providing timely and compliant Investigational Products and information.
CP&S is actively involved from initial Sponsor contact with Medpace through study close-out. CP&S reviews the Sponsor’s request and supporting documentation, to develop preliminary supply strategy and, budget and, incorporating it into a complete proposal to the Sponsor. CP&S supports BID Defense, as needed, with focused Investigational Product discussion. Upon-study award to Medpace, CP&S becomes an active member of the Clinical Project Team.
At study close-out CP&S works to ensure all Investigational Products are reconciled and appropriately dispositioned.
Throughout, CP&S provides initial and ongoing proactive risk identification, risk mitigation, and risk management. CP&S provides strategic study vision and operational excellence to ensure the right product, is in the right place, at the right time, for the right subject.