Clinical Trial 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 or emerging 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 need 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 conventional primary and secondary pharma packaging solutions or customized pharmaceutical packaging and labeling, we deliver with confidence. Recro can partner with you to deliver clinical supplies, tailored to your packaging and labeling 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. Recro’s cross functional team combined with a diverse preferred group of partners will help satisfy your project needs. 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:

  • 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
  • Limited-access and security-enabled storage areas

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. Our packaging, labeling, and shipping flexibility allow us to reduce drug and comparator waste.

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

  • 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
  • Specialized labeling for drug supply flexibility
  • Customized kits designed for compliance, quality, and storage ease
  • 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 tailored approach to 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
  • Facilitating clinical label design and translation services
  • Regulatory assistance

Global Distribution & Clinical Trial Logistics Partners

Your Recro project management team actively forecasts your clinical supply plans and works with our logistics partners that oversee and control your shipments. Our seasoned logistics experts match the best shipping resources to your needs for the most efficient and reliable clinical trial supply chain solution.

To support global distribution and logistics, we provide:

  • Metrics reporting
  • Domestic and international shipment documentation
  • Development of distribution protocol covering all supply chain requirements
  • Inventories strategically located for patient dosing
  • 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
  • Provides certificates of destruction
  • Regulatory compliance and documentation support
  • 24/7 video security surveillance

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)

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