clinicalSMART™
clinicalSMART™ (Supply Management and Readiness Team) is our dedicated clinical supply management service, designed to bring clarity and control to complex clinical programs and support studies from early development through trial completion.
Built to move trials forward
We accelerate clinical trial success through expert, integrated clinical supply management, ensuring life-changing medicines reach patients quickly and reliably. By combining deep expertise in manufacturing, packaging, and supply chain management, we deliver seamless clinical trial supply solutions.
Control from strategy to site
We develop robust drug supply strategies and accurate demand forecasts while providing informed input into clinical protocol design to ensure operational readiness from the outset. Through strong cross-functional team leadership, we align stakeholders, streamline decision-making, and keep clinical programs on track from planning through execution.
We manage outsourcing activities and RFQ preparation, design and oversee IRT systems, including UAT, and develop label text that aligns with both clinical protocols and regulatory requirements. Our team coordinates packaging and scheduling, oversees lot release and global distribution, and actively tracks shipments while managing temperature excursions to ensure product integrity and uninterrupted trial supply.
Site and depot support is delivered through continuous inventory monitoring and supply optimization to ensure the right product is available at the right time. We track screening and enrollment activity in real time, adjusting supply strategies as trials evolve, and coordinate clinical trial close-out activities to ensure an efficient, controlled, and compliant conclusion.
Consistency and compliance
Our value-added process support helps build, refine, and strengthen clinical supply operations whether working within your existing quality systems or helping establish them from the ground up.
Our Clinical Supply Managers support SOP development and optimization, label text approval workflows, temperature excursion procedures, and lot release, recall, and recovery processes to ensure consistency, compliance, and operational readiness.
Work. Smart.
Working with our clinicalSMART™ Clinical Supply Managers gives you access to experienced, dedicated project managers and scalable support without increasing internal headcount. Our team brings deep expertise across individual trials or entire programs, providing full lifecycle support from protocol development through trial close.
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. Accellerated.
SMART FHD™ (First Human Dose Acceleration) is our specialized service designed to compress the path to clinic from years to months by rapidly advancing solid oral dose drugs from candidate selection to First Human Dose trials.
Compressing the path to clinic
Delivered by a fully integrated team of Clinical Supply Managers, Regulatory Scientists, Formulation Experts, Packaging Technologists, Analytical Chemists, and Quality Assurance/QPs, SMART FHD™ provides end-to-end oversight and execution.
Our services include manufacture of min/max drug-in-capsule dosages, bracketed stability studies with regulatory reporting, clinical labeling, packaging, and distribution, CMC compilation for regulatory submission, and QP release, ensuring speed, control, and confidence at every step.
SMART FHD™ delivers faster time to clinic and market by providing rapid access to early-phase clinical data while eliminating redundant development steps. This streamlined approach drives significant time and cost savings, supported by a white-glove service model that spans development through execution. With built-in supply flexibility through Phase 2a and beyond, SMART FHD™ helps keep programs moving efficiently as they scale.
Non-Sterile Clinical Trial Services
Structure in every stage, momentum for every milestone, managing every detail, guiding you seamlessly from clinical development to launch.
Learn more about our non-sterile capabilities and how we deliver safe, reliable, and scalable solutions across a broad range of oral dosage forms.
Contact us today to talk to our expert customer services team about how we can support you with clinical trial project management services.