Strategic Planning for Clinical Supply Forecasting: Building a Resilient Supply Chain

The planning phase of clinical supply forecasting (CSF) sets the foundation for successful trial execution by ensuring supply availability aligns with demand and compliance requirements. Robust CSF during this stage not only streamlines operations but also mitigates risks and improves trial efficiency. In this blog, we take a closer look at the key components of the planning phase and how they impact study outcomes.

Effective forecasting starts with a detailed understanding of trial-specific demands. CSF tools analyze:

• Study protocols: Evaluating study-specific needs based on treatment regimens and study design (e.g., double blind)
• Patient enrollment rates: Estimating supply requirements based on projected and real-time recruitment data
• Country/site-specific needs: Tailoring forecasts to account for site logistics, local regulations, and patient populations
• Drug product manufacturing and expiry date management: Aligning your manufacturing runs with your finished good investigational medicinal product (IMP) packaging campaign(s) to ensure expiration dates cover the life of the trial

By integrating these factors, demand assessments help clinical teams project supply requirements with precision, reducing the risk of shortages or overstocking.

Forecasting tools configure supply parameters to reflect the unique design and geographic scope of each trial. This step includes:

• Aligning supply timelines with study milestones
• Accounting for regional distribution challenges, such as customs regulations and transportation limitations
• Ensuring logistics strategies align with storage conditions and product stability

This alignment ensures that every aspect of the supply chain supports the trial’s operational goals.

Regulatory compliance and operational feasibility are non-negotiable in clinical trials. Forecasting solutions incorporate:

• Import/export regulations: Anticipating and planning for country-specific customs requirements
• Storage conditions: Ensuring facilities meet the necessary standards for temperature, humidity, and product safety

This proactive approach ensures supply plans meet both regulatory standards and practical considerations.

Clinical trials are dynamic, with variables such as enrollment fluctuations and protocol amendments affecting supply needs. Scenario modeling provides a way to:

• Simulate ‘what-if’ scenarios, such as unexpected recruitment surges, shipment delays, and/or study disruptions
• Adjust supply plans proactively to address potential disruptions

Advanced modeling empowers teams to build resilience into their supply strategies, minimizing trial interruptions.

Collaboration is at the heart of effective clinical supply forecasting. Input from:

• Clinical operations: Ensures supply plans align with protocol and patient needs
• Clinical development: Confirms investigational product (IP) kit designs align with dosing requirements
• Manufacturing: Shares details on timing of drug product availability based on active pharmaceutical ingredients (API) production
• Packaging and labeling vendor: Provides information pertaining to production capabilities and timelines for release
• Logistics: Offers insights into distribution capabilities and constraints
• Site: Shares on-the-ground perspectives for local requirements

This cross-functional approach creates a comprehensive forecasting model that supports seamless execution.

The planning phase of clinical supply forecasting is critical to building a robust, adaptive supply chain. By leveraging advanced tools and fostering collaboration, sponsors and supply chain teams can anticipate challenges, align with regulatory standards, and support trial success. In an industry where precision and agility are paramount, a well-orchestrated planning phase lays the groundwork for operational excellence and patient-centric outcomes.

Do you need help optimizing your clinical supply forecasting? At Clinical Supply Consulting (CSC), we provide tailored solutions to enhance accuracy, streamline operations, and drive efficiency across the entire supply chain. Our team leverages advanced tools and data-driven insights to help you achieve better outcomes and continuous improvement in future trials. Contact one of our experts today.