For over 30 years, IPAK has partnered with leading medical, healthcare, and life science organizations to deliver secure, compliant, and highly scalable medical kitting and fulfillment operations. We support diagnostic programs, clinical trials and clinical research by managing every component with accuracy, chain of custody discipline, and end-to-end traceability.
Whether you’re running a decentralized clinical trial, a large-scale direct-to-participant (DTP) program, or need specialized supply chain management, IPAK provides the expertise and infrastructure to safeguard materials, uphold compliance, and protect participant data.
Seamless, Secure Direct-to-Participant (DTP) Workflow
Our comprehensive, technology-enabled solution manages the entire kit lifecycle, from initial assembly to final return to lab.
1. Kit Manufacturing, Assembly & Inventory Management
- Compliant Facilities: Inventory is stored in our FDA-registered facility in a structured, tiered racking system. We maintain ambient temperature-controlled storage adhering to regulatory frameworks
- High-Volume Capacity: Proven experience processing over 25 million units of sensitive materials annually, demonstrating agile capacity to scale from 5,000 to millions of kits annually.
- Integrated Intake: All materials are inspected, verified via barcode scanning, and logged into our proprietary inventory management system using first-expiry/first-out (FEFO) logic to ensure compliance and prevent waste.
2. Direct-to-Participant Distribution
- Time-Sensitive Expertise: Deep experience distributing time-and-temperature sensitive materials direct to homes, clinics, and government sites nationwide.
- Compliant Packaging: Expert assembly and distribution using validated packaging solutions. When programs require it, we support packaging approaches aligned with standards such as IATA and UN regulatory guidelines.
- Data Security: All program data is handled through controlled, access-limited systems with audit logging, permission-based roles, and standardized procedures for protecting sensitive information at every stage.
3. Return Receipt, Accessioning & Repackaging
- Controlled Intake: Returned kits and materials are received through a documented intake process that includes scan-based verification, chain-of-custody tracking, and standardized QC procedures.
- Accessioning & Quality Review: Each return is logged, validated, and matched to its originating order using controlled workflows and dual-QC checkpoints designed to support high accuracy and data integrity.
- Secure Repackaging: Materials are prepared for their next destination using validated, compliant packaging methods that meet the requirements of regulated healthcare, diagnostic, and clinical programs. When specialized packaging standards apply, IPAK follows the appropriate industry guidelines.
- Timely Processing: Our operational model supports fast, predictable turnaround times to keep programs running smoothly, even at scale.
Technology & Compliance: The IPAK Difference
Proprietary Technology: IPIK™ Inventory Platform
Our proprietary platform, IPIK™, provides an unparalleled level of transparency and control for your program:
- End-to-End Traceability: IPIK™ tracks materials from incoming receipt through kit assembly, inventory movements, fulfillment, return processing, and accessioning, giving your team full program oversight.
- Real-Time Visibility: Secure, role-based access lets your team view live dashboards with item-level details, including on-hand quantities, lot information, status updates, and location history.
- System Integration: IPIK™ supports integration with client systems through API or secure data export, enabling seamless sharing of order data, inventory feeds, status updates, and shipment confirmations.
- Proactive Alerts: Automated alerts for critical thresholds, such as low inventory, expiring lots, or upcoming replenishment needs, help prevent delays and keep programs running smoothly.
Ready to ensure the security, compliance, and efficiency of your next kitting program?
Contact Us here to speak with a team member about your healthcare kitting and fulfillment needs.