Investigational Product Solutions

Seamless Management of Clinical Packaging and Supplies for Every Phase of Your Trial

iGlobal Investigational Product Solutions (IPS) department simplifies the complexities of providing timely, compliant investigational products (IP) across your clinical trial lifecycle.

From strategic planning to operational execution, we ensure that every aspect of your clinical supply chain is optimized to meet critical timelines and regulatory requirements. Whether taking the lead or providing tailored support, IPS offers a unified, end-to-end solution that integrates seamlessly into your trial strategy.

Comprehensive Services for Investigational Product Management

Strategic Services:

  • Vendor recommendations: Tailored to your trial’s requirements.
  • Timeline development: To align IP readiness with key study milestones.
  • Depot set-up and management: To support global distribution and compliance.
  • Integrated supply chain management: Ensuring efficiency and transparency.

Operational Services:

  • Vendor, supply, and inventory management: To ensure real-time oversight.
  • Label design, development, and compliant packaging solutions.
  • Initial and resupply strategies: To maintain seamless treatment continuity.
  • Internal and external IRT (Interactive Response Technology) collaboration: Including specifications and User Acceptance Testing (UAT).

Why Choose iGlobal IPS?

Integrated Efficiency for Every Trial Phase

Unlike fragmented models where IP management is outsourced to multiple vendors, iGlobal’s IPS operates as a fully integrated, centralized function. By working within our full-service CRO framework, IPS ensures clear communication, cohesive planning, and the elimination of gaps or redundancies across clinical study activities.

This approach is particularly beneficial for small and mid-sized biotech and biopharma companies, enabling “one-stop shopping” for clinical packaging and supply needs.

Global Coordination

Leveraging a robust global network, our IPS team ensures that investigational products are delivered on time and in compliance with local regulations. We work collaboratively with sponsors and vendors to establish a tripartite relationship built on transparency, trust, and shared goals.

End-to-End Support

From study start-up to close-out, IPS remains actively involved, providing:

  • Supply Strategy Development: Tailored plans that anticipate potential risks and ensure readiness for the first-patient-first-dose (FPFD).
  • Budget Integration: Accurate and comprehensive budgeting for IP management, incorporated into your trial proposal.
  • Risk Management: Proactive identification, mitigation, and management of supply chain risks throughout the study.
  • Study Close-Out: Reconciliation and appropriate disposition of all investigational products, ensuring compliance and accountability.

Making the Intricate Effortless with iGlobal IPS

At iGlobal, our IPS team goes beyond logistics to provide strategic vision and operational excellence. Our mission is to ensure that the right product is in the right place, at the right time, for the right subject—every time. By integrating seamlessly into the clinical project team, IPS actively contributes to study success with:

  • Expert coordination: Of multiple, concurrent supply tasks in complex regulatory environments.
  • Real-time adjustments: To meet evolving trial needs without disrupting timelines or quality.
  • A focus on precision, efficiency, and sponsor satisfaction: From project initiation to completion.

Accelerate Your Trial with iGlobal IPS

When you partner with iGlobal Investigational Product Solutions, you gain a trusted ally dedicated to delivering timely, compliant, and reliable clinical packaging and supply management. From start to finish, we make the intricate seamless, enabling you to focus on advancing life-changing therapies.

Contact iGlobal IPS today to learn how we can support your clinical trial success.

Vendor & Supply Chain Coordination

Trusted Vendor Network and Comprehensive Oversight

iGlobal IPS leverages a global network of pre-qualified vendors to support compounds at any development stage. We manage and/or coordinate:

  • API Manufacture: Source and manage active pharmaceutical ingredient production.
  • Bulk Manufacture: Oversee production of investigational products at scale.
  • Primary & Secondary Packaging and Labeling: Ensure compliant, high-quality packaging and labeling for both site-dispensed and take-home use.
  • Documentation & Compliance: Review pre- and post-production documents for accuracy and adherence to regulatory standards.
  • Product Logistics: Facilitate product release, storage, depot distribution, and shipment to sites.
  • Reconciliation & Disposition: Manage returns, reconciliation, and compliant destruction of unused IP.
Efficient Timeline Management

Concurrent Strategies for Global Compliance

Our IPS team develops and coordinates timelines that integrate efficiency at every level, eliminating unnecessary sequential processes. We align global, regional, and local requirements with other functional areas to ensure timely execution, including:

  • Seamless collaboration: Between sponsors, vendors, and iGlobal teams.
  • Implementing concurrent activities: Where feasible, to accelerate delivery.
  • Adapting to study-specific requirements: Such as country approvals, site initiations, and enrollment projections.
Supply Strategies & Resupply Optimization

Proactive Inventory Management for Uninterrupted Study Conduct

Our IPS experts develop and implement strategies to optimize inventory at depots and sites, ensuring the availability of investigational products throughout the study. Key activities include:

  • Depot setup strategies: Including obtaining Import Licenses and identifying appropriate Importers of Record.
  • Maintaining inventory balance: By tracking shipment patterns and depot levels to avoid excess or shortages.
  • Planning resupply shipments: Based on site initiation schedules, enrollment trends, and country-specific timelines.

Preventive Optimization: Real-time monitoring and proactive adjustments prevent shipment delays, inventory imbalances, and excess product waste.

Advanced IRT Collaboration

Integrated Inventory and Stability Management

Our IPS team collaborates with iTrack IRT™, iGlobal’s proprietary Interactive Response Technology platform, to ensure real-time inventory management at depots and sites. This includes:

  • Coordinating initial and resupply shipments: To maintain product availability.
  • Managing use-by dates: Minimizing relabeling activities and reducing product waste.
  • Monitoring temperature excursions: To ensure product stability and compliance.
  • Reconciling product usage, returns, and destruction: In adherence to regulatory standards.

With expertise in concurrent stability programs: IPS maximizes product shelf life and minimizes costly date extension relabeling processes.

Integrated Supply Chain Solutions

From Label Design to Regulatory Submissions

iGlobal IPS integrates seamlessly with study start-up teams to plan and manage all aspects of the investigational product supply chain, including:

  • Label Development: Designing global booklet labels to maximize compliance and inventory efficiency while avoiding the limitations of regional or single-panel labels.
  • Regulatory Submission Preparation: Ensuring labels and packaging meet global standards for inclusion in regulatory documentation.
  • Inventory Optimization: Avoiding delays or disruptions by ensuring compliance and usability of IP labels.

The iGlobal Advantage in Investigational Product Solutions

Unparalleled Efficiency:
Our integrated model eliminates redundancies, accelerates timelines, and ensures compliance from production to patient.

Proactive Risk Management:
IPS provides ongoing risk identification, mitigation, and management throughout the trial lifecycle.

Global Expertise, Local Precision:
Leveraging regional insights and a trusted global network, we deliver solutions tailored to your trial's unique needs.

End-to-End Support:
From strategy development to study close-out, IPS ensures investigational products are delivered, tracked, and reconciled with precision and transparency.

Partner with iGlobal IPS for seamless investigational product management that simplifies complexity and accelerates trial success.