Clinical Trial Packaging & Logistics Services

Fast, Flexible, and Responsive

Today’s clinical studies are increasingly complex and ever-changing — and they demand flexible clinical trial supply chain management solutions. Whether you are a small and emerging or large biopharmaceutical company looking for the attention you demand for your projects, Recro is the right company for you. Whether your study is on a larger scale or you’re investigating a niche product, we provide focused, flexible, responsive collaboration to ensure that as your clinical trials needs change, we quickly adapt with up-to-the-minute clinical trial packaging and logistics solutions. Ours is a nimble, low-bureaucracy organization where you’ll have direct access not only to our global supply chain experts but also to unparalleled regulatory expertise. Whether your needs include traditional primary and secondary pharma packaging solutions or on-demand pharmaceutical packaging and labeling with direct-to-patient distribution, we deliver confidence. Recro will deliver the clinical trial supplies you need when you need them, packaged and labeled to your exact specifications.

Clinical Trial Supply Chain Management

Our goal at Recro is to ensure the most efficient and cost-effective overall clinical trial supply strategy for your protocol. Highly collaborative, accessible project management is the hallmark of our organization. We will work with you to develop and guide your supply chain strategy with comprehensive end-to-end study coverage, including:

  • Manufacturing — filling, blinding, dosing, over-encapsulation
  • Analytical testing — product release, stability studies, comparator testing
  • Forecasting — sites, inventory, optimized packaging campaigns
  • Comparator procurement
  • Packaging — primary and secondary
  • Labeling — single panel or booklet
  • Controlled temperature storage
  • Distribution and logistics — complete support for transport, distribution, and documented chain-of-custody management
  • Returns and destruction

Warehousing and Storage

Recro’s cGMP validated and monitored warehousing provides orderly clinical trial supply chain management you can rely on to hold your materials in prime condition. Our facility features:

  • Process-flow floorplan and cGMP compliance
  • Validated and dedicated temperature storage areas for drugs, their components, and ancillary materials
  • Controlled room temperature monitoring
  • 24/7 alarmed monitoring of all products and all temperature ranges
  • Full emergency backup generators
  • Part 11-compliant inventory control capability that provides accountability and traceability in real time
  • Limited-access and security-enabled storage areas

Direct-to-Patient Distribution

Clinical trial patient enrollment and retention is a growing challenge for clinical teams developing new drugs. “Virtual” is becoming the new reality. Patients, specifically those who are homebound, ill, in remote locations, or concerned about the latest virus, are avoiding health care facilities altogether.

Recro’s direct-to-patient distribution helps you reach these patients. Advantages of this strategy are:

  • Ideally suited for rare disease, remote locations, orphan drugs, and dispersed patient populations
  • Our distribution team develops a custom logistic plan per patient per protocol
  • Precludes shipping and storing supplies at an investigator site
  • Option to use Recro’s courier or choose your own
  • cGMP compliant, meeting 21 CFR and Annex 13 requirements
  • Patient privacy is a priority
  • Suitable for drugs in short supply, or with limited shelf lives

Primary and Secondary Packaging and Labeling Services

Recro fulfills the most complex packaging and labeling demands, whether for a global Phase III or an orphan drug trial with widely dispersed patients. All our clinical packaging and labeling services are performed under cGMP and EU GMP conditions and meet 21 CFR and Annex 13 requirements. We offer traditional packaging campaigns or our on-demand packing, labeling, and shipping flexibility allows us to reduce drug and comparator waste.

Features of our clinical trial pharmaceutical packaging and labeling services are:

  • Large receiving, raw material, and bright stock storage area
  • Gowning, warehousing, and inspection areas
  • GMP primary and secondary packaging room
  • Potent compound packaging
  • Bright stock bottling and blistering capabilities
  • On-demand labeling for drug supply flexibility
  • Customized kits designed for compliance, quality, and storage ease
  • Expedited packaging runs in the event of last-minute demands
  • Staggered packaging runs scheduled to accommodate drug supply and time constraints
  • Large packaging runs that lower costs when drug supply and patient recruitment is high

Our secondary packaging and clinical labeling services include:

  • Traditional or on-demand clinical packaging and labeling solutions
  • Temperature and humidity-controlled storage and distribution
  • Patient kit assembly and labeling using a wide range of packaging types
  • Stability, child-resistant, and senior-friendly packaging
  • Expiry date extension labeling
  • Label application — single and multi-panel, booklet labels
  • De-labeling and re-labeling
  • Label translation and third-party vendor label text generation
  • Regulatory assistance

Global Distribution & Clinical Trial Logistics

Your Recro project management team actively forecasts your clinical supply plans and works with our logistics partners that oversee and control your regional and global shipments. Our seasoned logistics experts match the best shipping resources to your needs for the most efficient and reliable clinical trial supply chain solution. Unsurpassed knowledge of local regulatory requirements de-risks the process.

To support global distribution and logistics, we provide:

  • Metrics reporting
  • Domestic and international shipment documentation
  • Full-service international shipping management, including all necessary customs paperwork
  • Development of distribution protocol covering all supply chain requirements
  • QP audit services for importation into Europe
  • QP release services for materials distributed to clinical sites within EU countries
  • Inventories strategically located for patient dosing
  • Automated shipment delay notifications
  • Courier tracking information

Clinical Returns, Reconciliation, and Destruction

Planning for clinical returns may not be the first thing you think of, but proper execution and compliance with local regulations in this area is critical for every study. Our services include:

  • Reconciliation services for clinical site returns of investigational product
  • Storage capacity post-reconciliation, maintaining cGMP standards
  • Preparation of clinical trial material for destruction
  • Issuing of certificates of destruction
  • Regulatory compliance and documentation support
  • 24/7 video security surveillance
  • Biometric access and badge readers

Exceptional Regulatory Expertise

Our regulatory experts have the experience you need to streamline your product’s pathway from IND to NDA and regulatory approval. With highly experienced regulatory experts providing sound regulatory strategies including FDA meeting guidance and submissions preparation, at Recro, you’ll confidently anticipate challenges and bypass risks as you attain your program milestones.

Our regulatory benefits include:

  • Successful inspection history with the FDA, DEA, and foreign health ministries
  • Regular quality audits by clients and consultants, including virtual visits
  • Assistance with end-to-end filing strategies, including for global markets and specialty designations (e.g., orphan drug)

Need Help With Clinical Trial Supply Chain Management?

Recro Is Your Clinical Trial Packaging and Distribution Solution.

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