When planning a clinical trial and developing the associated budget and timeline, it is important to consider detailed elements that will be essential to the packaging process. There are often critical variables (e.g. expiry date or full stability information) that will influence whether everything should be packaged up front, or if a multi-phase plan makes more sense. The earlier these issues are considered, the more accurate the budget and timeline.
Because most clinical trial sponsors use external suppliers to support the packaging and labeling process, full transparency is essential. To develop an accurate cost estimate and supporting implementation plan, the trial sponsor must be prepared to share the following information with their supplier:
- Safety Data Sheet: Be prepared to provide the safety data sheet for all drug products involved in your study. The supplier’s Environmental Health & Safety department must evaluate each drug product to determine if special precautions are required for your packaging operations (e.g. dedicated product contact parts, PAPR protective equipment or HEPA hood).
- Protocol Number: Share the protocol documentation so the supplier can understand if the study is open label, blinded or randomized. They will also need to understand considerations involved for participating countries, number of clinical sites and number of site shipments per month.
- Drug Handling Requirements: Is your product a DEA controlled substance? Will the product require packaging in a low humidity environment or special lighting conditions? It’s also helpful to disclose if the drug needs to be stored in one temperature condition but will be packaged in another (e.g. frozen gets thawed for labeling or refrigerated product is stored ambient after packaging).
- Number of Bulk Drug Lots: This determines how many production job steps are required, which will impact job scheduling, staffing and associated costs.
- Quantity of Products to Produce: Think about how many blister strips, blister cards, bottles and kits you need. Be prepared to include overage in your quantities to account for product loss during production e.g. planned loss related to quality assurance testing.
- Packaging Materials: Specify if you will supply the materials or if you’d like your supplier to own that step. Tell them if materials have already been chosen. If so, provide specification sheets so your packaging supplier can evaluate any issues with lead time or product specifications based on your source.
- Fill Count of Blisters or Bottles: Determine the package configuration as it relates to the study dosing schedule and patient compliance. For example, does it make sense to use bottles if a blister card is a more convenient option for patients? For bottles, are special closures required (e.g. induction seals with print, child resistant features)? What is the fill count per bottle?
- Blister Card Design: What is the dosing schedule? How many days of dosing should the blister card contain?
- Labels: Decide if a single panel or booklet label is required based on the participating countries. Who will be responsible for translations? Is the sponsor supplying the translations, or is the packaging supplier to manage translations, or will another 3rd party be involved? Are there regulatory requirements for different countries/regions that will impact label production? Who will be responsible for regulatory review--the sponsor, the supplier or a different 3rd party?
- Kitting: If kitting is required, how many blister cards/bottles/vials will be included in the kit? What is the randomization strategy, and who will be supplying and managing the randomization / kit list?
Gaps in study information can result in an inaccurate quote which may lead to unforeseen surprises that require additional time for clarification and revision. By providing this information in advance, you reduce the time it takes to issue an accurate and comprehensive clinical trial packaging quote.
Sponsors appreciate attention to detail and have been very successful in partnering with Fisher Clinical Services for their packaging needs. Learn more about a blistering package project Tia guided to deliver an optimal, cost-effective solution for her study sponsor. Key requirements included:
• Gathering information to scope the project appropriately
• Evaluating all the tools and materials required to produce a quality product
• Minimizing time delays and cost increases by engaging an expert