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Dow development laboratories, llc is a company specialized in topical drug product manufacturing and formulation. We take pride in providing top-notch services for topical formulation design.
Dow development laboratories, llc is a company specialized in topical drug product manufacturing and formulation. We take pride in providing top-notch services for topical formulation design.
A solid red lipstick kiss mark is printed on a white background, capturing the essence of the K.I.S.S. principle—keep it simple and striking.

Management of IP for Your Clinical Study – K.I.S.S.

Keep It Simple, Smart.

Planning for investigational product (IP) supply in a clinical study is often more complex than it seems—but the guiding principle should always be to Keep It Simple, Smart (yes, we’re softening the original “stupid” just a bit!). Complexity can be the enemy of efficiency, clarity, and compliance.

The primary objectives for anyone managing clinical trial IP are straightforward:

– Ensure the product is well-packaged and protected
– Use clear, compliant labeling
– Maintain appropriate storage conditions
– Ensure on-time availability at the clinical site
– Enable error-free dispensing per the study protocol

Preventing Errors and Delays Starts with Good Planning

From the outset, the IP strategy should be designed to avoid:

– Use errors by study participants
– Dispensing errors by site staff
– Inventory disruptions or supply gaps

Whether you’re working with an interactive web response system (IWRS) or using a simpler manual system, active oversight is essential. Don’t assume automation means perfection. Excessive or uncoordinated shipments increase risk: delays, temperature excursions, product damage, and higher shipping costs. They also create more administrative burden for sites, who must receive, inventory, and manage these materials—leaving room for misplaced IP and potential deviations.

Smart Labeling and Storage Matter

Well-designed labeling—legible, intuitive, and clearly marked with IP numbers—can dramatically reduce the risk of both site and subject errors. Make sure it’s easy for staff to match IP to subjects, and for subjects to correctly use what they’re given.

Additionally, careful tracking of expiry and retest dates is critical. Outdated product slipping through the cracks is a preventable issue that can become a costly compliance or protocol problem. Establishing a clear, documented plan for monitoring these dates can make all the difference.

Oversight Beats Overcomplication

Whether you’re managing one site or dozens, keeping the process simple—but robust—is key. A well-designed IP supply strategy ensures product is always where it needs to be, when it needs to be there, without overcomplicating the system or overburdening your sites.

As Einstein famously said,
“Everything should be made as simple as possible, but not simpler.”

We couldn’t agree more. Simplify. Then simplify again.

References

  • FDA Guidance for Industry: Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND – https://www.fda.gov/media/116156/download
  • ICH E6(R2): Good Clinical Practice Guidelines – https://www.ich.org/page/efficacy-guidelines
  • MHRA Guidance on Labelling and Packaging of Investigational Medicinal Products – https://www.gov.uk/guidance/investigational-medicinal-products-imps-overview
  • Clinical Trials Transformation Initiative (CTTI): Best Practices for IP Management – https://www.ctti-clinicaltrials.org/projects/investigational-product-supply