Expertise
Hundreds of years collective experience in clinical supply, manufacturing, and global operations.
Accelerated ClinicalSMART™
Expert clinical supply management from protocol to patient, combining decades of expertise across manufacturing, packaging, and supply chain management to deliver seamless solutions that support development, reduce complexity, and improve patient outcomes.
Our ClinicalSMART™ (Supply Management and Readiness) team delivers industry-leading clinical supply project management, supporting programs across all phases of development.
Supply. Seamless.
Our experienced Clinical Supply Managers provide strategic, operational, and regulatory guidance to keep trials running smoothly from planning through execution. We offer flexible, end-to-end clinical supply support tailored to specific study requirements, with fully customizable and scalable services designed to align with evolving clinical plans.
- RFQ preparation for outsourcing & vendor
- Leadership of cross-functional supply teams
- Protocol review & input on drug supply strategy
- Drug supply forecasting & demand planning
- Pharmacy manual input & review
- IRT system development & UAT coordination
Total operational control
We manage regulatory-compliant label text development, packaging coordination, and lot release activities, while providing end-to-end shipment tracking and proactive temperature excursion management.
Our teams maintain real-time visibility through site and depot inventory monitoring and continuously adjust study supply strategies based on enrollment trends. We also support seamless clinical trial close-out, ensuring accurate reconciliation and compliant completion.
One Team. One Plan.
Our ClinicalSMART™ managers support individual studies or full development programs, partnering closely with your team to define clear RACI-based collaboration while acting as dedicated advocates to keep clinical supply priorities aligned, visible, and consistently delivered. Additional support includes:
- Process and SOP development
- Authoring SOPs and process flows
- Label text approval
- Lot release support
- Temperature excursion management
- Product recall and recovery
Work. Smart.
We provide access to senior clinical supply project managers who offer flexible, consultative support or full operational execution as needed. With end-to-end management from protocol design through study close-out, we deliver supplemental expertise that strengthens teams without increasing internal headcount.
Our SMART RFQ™ process streamlines study start-up through a proven, disciplined approach. The clinicalSMART™ team ensures every quotation is precise, compliant, and fully aligned with study requirements, supported by a thorough review of study assumptions and supply planning. Peer-reviewed documentation and pricing, backed by hundreds of years of collective experience, are applied to every project to deliver clarity, accuracy, and confidence from the outset.
First Human Dose (FHD). Accelerated.
Accelerate your path to First-in-Human trials with our SMART FHD offering, which streamlines the journey from candidate selection to First Human Dose studies. Our integrated team of clinical supply managers, regulatory scientists, formulation experts, packaging technologists, analytical chemists, and QPs works collaboratively to reduce development timelines and accelerate clinical readiness.
Quicker path to clinic
Our SMART FHD approach delivers rapid access to clinical data, significant time and cost savings, and a true “white-glove” end-to-end service that eliminates redundant development activities. Flexible supply solutions support programs through Phase 2a and beyond, reducing traditional first-in-human timelines from up to two years to just a few months.
- Development & manufacture of drug-in-capsule
- Method qualification & bracketed stability studies
- GMP manufacturing, packaging, labeling, and QP release
- CMC documentation for regulatory submission
- Clinical inventory management
- Global distribution
- Project management oversight all stages
Acceleration from concept to commercialization
Integration
Fully integrated global capabilities spanning the entire supply chain, from planning to delivery.
Performance
Proven delivery of customized, efficient, and compliant solutions across diverse programs.
Partnership
A committed partner focused on accelerating clinical development with confidence and control.
Speed Solutions
Our integrated services simplify and accelerate the supply chain, reduce time-to-market, and help ensure the timely, reliable delivery of life-changing therapies.