Medpace has a dedicated Clinical Packaging and Supplies (CP&S) department to assist Sponsors with the complexities of providing timely and compliant product throughout clinical studies. Mary Ellen Weber, D.M.D., M.P.H., Director of Clinical Packaging & Supplies at Medpace, walks us through this service offering and the added value it affords to our Sponsors.
Q – Can you provide a high-level overview of what Medpace offers as part of its CP&S function?
CP&S can provide a wide range of support to Sponsors, from taking the lead for managing Investigative Product, to support based on specific requirements. Below is a highlight of the key services followed by a more detailed description.
|Vendor recommendations||Vendor, supply, and inventory management|
|Timeline development||Manage timelines|
|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|
Medpace has a network of pre-qualified vendors for compounds in any stage of development. We can support and manage: API manufacture; Bulk manufacture; Primary packaging; Clinical labelling; Batch record development and review; Product release and storage; Shipment to depots and sites; Reconciliation, returns, and destruction.
CP&S will develop, manage, and coordinate timelines within and across Medpace, the Sponsor and vendor. CP&S will develop and manage timelines to affect efficiencies by implementing concurrency where applicable, rather than sequential, and to meet global, regional, and/or local requirements, in conjunction with other functional areas.
Depot set-up and management:
Based on study timelines, country approval dates, site initiation schedules, and enrollment forecasts, CP&S will develop and implement a depot set-up strategy to insure all depots have a confirmed Importer of Record strategy, and adequate quantities of Investigational Product. CP&S will 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 will optimize shipments and inventory levels at the depot and sites.
Internal and external IRT collaboration to develop IRT specifications and User Acceptance testing
CP&S will collaborate ClinTrak IRT® for: inventory management at the depot and site level; for initial and resupply shipments; for use-by date management; product disposition; temperature excursions; subject dosing; reconciliation, returns, and destruction.
Because many clinical studies are performed concurrent with stability programs, and, knowing that use-by dates are printed on global labels, CP&S is an active participant in understanding the stability program, the stability pull dates, and data availability, with the goal of maximizing use-by date, while minimizing date extension labelling activities.
Supply chain management:
Working in collaboration with Medpace’s study start-up team, CP&S develops, plans, implements, and manages Investigation Product supply chain activities to insure timely and compliant product availability including label development, approval, and compilation for Regulatory submissions.
Labels are where the IP timeline is made or broken
Labels will be developed, based on whether product is used on site, or dispensed to the subject for take home use, to insure maximum compliance, based on ease of directions. Labels are where the IP timeline is made or broken. Medpace works to include all countries in the global booklet label, to avoid subsequent booklet label manufacture and to avoid regional or single panel labels and inventory, as well as provide a fully useable global inventory with the fewest restrictions.
From an initial US English master label text, the label is distributed concurrently to global colleagues for country localization, translation, and regulatory compliance. These labels come back, are consolidated by Medpace, then forwarded to the vendor to be set. They are returned to Medpace and again fanned out to global colleagues for final review and approval prior to printing. Label development, review, approval, and printing must be concurrent with supply chain activities, to insure simultaneous availability of labels and bulk product.
Q – What benefits can a Sponsor expect from using Medpace’s CP&S?
Sponsors and studies of any size can benefit.
For small to mid-size biotech and biopharma companies, CP&S works within the Medpace full-service CRO model. This is particularly beneficial as Sponsors can rely on Medpace for “one-stop shopping.”
For large Sponsors and large studies, CP&S works with a global network of colleagues and vendors to insure all operational activities are coordinated to meet first patient first dose date. CP&S understands, communicates, and collaborates within the three-pronged relationship of Medpace, Sponsor, and Vendor, by taking the lead, or serving in a supporting role.
Regardless of project and company size, CP&S manages multiple, concurrent, and sequential documents, tasks, and processes, to provide a consolidated, unified approach in a complex 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.
Q – Medpace has positioned CP&S as a distinct service offering. How does this differ from other CROs?
Medpace offers CP&S as part of its 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. Inherently, either of these models have gaps or duplications, thus creating inefficiencies.
By having CP&S as an internal function, Medpace is providing a consolidated unified approach to study start-up, recruitment, treatment, and follow-up. This allows for improved communication, collaboration, roles and responsibilities, thereby eliminating potential inefficient gaps and/or duplications.
Q – How is Medpace helping to make the complex seamless in the context of CP&S services and support?
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.
This is affected through internal inter-departmental collaboration with Medpace colleagues, as well as external collaboration with the Sponsor and Vendor(s).
CP&S is actively involved in Medpace processes from the time a Sponsor contacts Medpace for a potential study, through study close-out.
CP&S reviews the Sponsor’s request, including clinical study protocol and other available documentation, to develop preliminary supply strategy, preliminary budget, and incorporate it into a complete proposal to the Sponsor.
Upon award of the study to Medpace, CP&S becomes an active member of the Clinical Trial Team, providing strategic study vision and operational excellence to insure the right product, is in the right place, at the right time, for the right subject.
At study close-out CP&S works to insure all Investigational Products are reconciled and destroyed.
Throughout, CP&S provides initial and ongoing proactive risk identification, risk mitigation, and risk management.