Advanced Clinical Supply Chain Management Training Course

Advanced Clinical Supply Chain Management Training Course

Introduction

The Advanced Clinical Supply Chain Management course is a critical and timely response to the increasing complexity and dynamic nature of global clinical trials. In the hyper-regulated, high-stakes environment of biopharma, where product integrity and patient safety are paramount, an agile and resilient supply chain is no longer a luxury it's a core strategic imperative. Advanced Clinical Supply Chain Management Training Course is specifically designed to transition supply chain professionals from tactical execution to strategic oversight, equipping them with mastery over end-to-end logistics, from Investigational Medicinal Product (IMP) manufacturing to Direct-to-Patient (DtP) delivery.

This program focuses heavily on modernizing clinical logistics through digital transformation and risk mitigation. Participants will delve into the critical areas of Good Clinical Practice (GCP) compliance, advanced cold chain logistics, and the implementation of technologies like AI-driven demand forecasting and blockchain for traceability. By integrating real-world case studies and practical, hands-on application, the curriculum ensures that graduates are prepared to optimize global distribution networks, enhance supply chain visibility, and ultimately accelerate the delivery of life-saving therapies to patients worldwide, securing a competitive advantage for their organizations.

Course Duration

10 days

Course Objectives

1. Master end-to-end Clinical Trial Supply Chain (CTSC) optimization for global studies.
2. Develop and implement proactive risk mitigation strategies to ensure supply chain resilience.
3. Achieve GCP/GMP compliance excellence across all clinical logistics and distribution operations.
4. Apply AI-driven demand forecasting and predictive analytics for IMP and ancillary supply.
5. Design and manage robust, state-of-the-art cold chain logistics for Advanced Therapeutic Medicinal Products (ATMPs) and temperature-sensitive biologics.
6. Lead the digital transformation of the CTSC, leveraging blockchain for traceability and security.
7. Integrate Direct-to-Patient (DtP) and Decentralized Clinical Trial (DCT) models into the supply strategy.
8. Streamline global regulatory affairs and customs clearance for cross-border shipments.
9. Implement strategic sourcing and advanced Contract Research Organization (CRO)/Contract Development and Manufacturing Organization (CDMO) vendor management.
10. Drive lean inventory management and JIT principles to reduce waste and cost.
11. Establish comprehensive supply chain visibility and real-time monitoring through IoT technologies.
12. Formulate and execute sustainable supply chain practices and ESG compliance in clinical trials.
13. Master Reverse Logistics and destruction procedures for unused or returned clinical materials.

Target Audience

1. Clinical Supply Chain Managers and Directors
2. Logistics and Distribution Professionals in Pharmaceuticals/Biotech
3. Clinical Operations Leaders
4. Quality Assurance and Compliance Specialists
5. Demand Planners and Forecasters in Biopharma
6. Supply Chain Consultants specializing in Healthcare/Life Sciences
7. Project Managers overseeing Clinical Trials
8. Procurement and Sourcing Managers for Trial Materials

Course Modules

Module 1: The Evolving Clinical Supply Chain Ecosystem

• Foundations
• Regulatory Frameworks
• Stakeholder Mapping.
• IMP Life Cycle.
• Case Study: Analyzing a major global trial delay due to a gap in sponsor-CRO handoff compliance.

Module 2: Strategic Planning and Clinical Demand Forecasting

• Protocol Impact.
• AI & ML Forecasting.
• Scenario Planning.
• Sizing & Budgeting.
• Case Study: Using machine learning to reduce overage and under-supply for a multi-indication oncology trial.

Module 3: Cold Chain & Temperature-Sensitive Logistics

• Biologic Integrity.
• Packaging Solutions
• IoT & Monitoring.
• Excursion Management.
• Case Study: Mitigating a large-scale cold chain excursion risk during a transit hub closure

Module 4: Digital Transformation and Technology Integration

• eClinical Systems.
• Blockchain Applications
• Digital Twin Concept.
• Process Automation.
• Case Study: Implementing a blockchain solution for end-to-end, tamper-proof traceability of a controlled substance IMP.

Module 5: Global Regulatory & Customs Compliance

• Import/Export.
• Customs Clearance.
• Labeling Compliance.
• Controlled Substances.
• Case Study: Developing a standardized global regulatory submission checklist for 10+ countries to achieve rapid clinical start-up.

Module 6: Risk Management and Supply Chain Resilience

• Risk Identification
• FMEA Analysis.
• Contingency Planning.
• Geopolitical Risk.
• Case Study: Re-designing the supply network after a primary manufacturing site was shut down due to a quality issue.

Module 7: Quality Assurance and Quality Control (QA/QC)

• Quality Management Systems (QMS).
• Deviation & CAPA.
• Serialization & Anti-Counterfeiting.
• Audit Readiness.
• Case Study: Conducting a mock FDA audit of a third-party logistics (3PL) partner and correcting major findings.

Module 8: Sourcing, Procurement, and Vendor Management

• Strategic Sourcing.
• RFI/RFP Process.
• SLA Negotiation
• Performance Metrics.
• Case Study: Negotiating a master services agreement (MSA) with a global logistics provider to ensure volume-based cost savings and fixed transit times.

Module 9: Direct-to-Patient (DtP) and Home Healthcare Models

• DCT Strategy.
• Patient-Centric Logistics.
• Regulatory Approval.
• Kit Management.
• Case Study: Launching a hybrid trial, successfully balancing site-based visits with DtP drug delivery across three continents.

Module 10: Inventory and Storage Optimization

• JIT vs. Safety Stock.
• Warehouse Design.
• Expiry Date Management.
• Returns and Accountability.
• Case Study: Implementing a new lean inventory system that reduced expiry material destruction costs by 30%.

Module 11: Financial Management and Cost Control

• Total Cost of Ownership (TCO)
• Budgeting & Forecasting.
• Cost-to-Serve Analysis.
• Invoicing & Reconciliation.
• Case Study: Identifying and rectifying significant financial discrepancies in a multi-country freight bill-back process.

Module 12: Reverse Logistics and Destruction

• Return Process.
• Accountability.
• Destruction Protocols.
• Regulatory Reporting.
• Case Study: Managing the complex and highly regulated destruction of a Schedule II narcotic IMP after trial closeout.

Module 13: Sustainability and Ethical Supply Chains

• ESG Compliance.
• Carbon Footprint Reduction.
• Ethical Sourcing.
• Green Logistics.
• Case Study: Transitioning a large clinical trial's packaging to fully recyclable/biodegradable materials, achieving a 15% reduction in plastic waste.

Module 14: Leadership and Cross-Functional Collaboration

• Silo-Busting.
• Crisis Communication.
• Key Performance Indicators (KPIs)
• Team Development.
• Case Study: Leading a cross-functional team to rapidly pivot supply strategy during a pandemic-related global shipping lockdown.

Module 15: Future Trends and Innovation in CTSC

• Personalized Medicine.
• Advanced Data Analytics.
• Hyper-Automation.
• Nearshoring/Reshoring.
• Case Study: Preparing the supply chain for the future launch of a highly complex, single-dose gene therapy product requiring specialized ultra-cold chain logistics.

Training Methodology

This course utilizes an intensive, Blended Learning approach combining advanced theory with real-world application to ensure deep retention and practical skill development.

• Interactive Lectures & Discussions.
• Case Study Analysis.
• Simulation & Workshops.
• Group Projects
• Guest Speakers.

Register as a group from 3 participants for a Discount

Send us an email: info@datastatresearch.org or call +254724527104 

Certification

Upon successful completion of this training, participants will be issued with a globally- recognized certificate.

Tailor-Made Course

 We also offer tailor-made courses based on your needs.

Key Notes

a. The participant must be conversant with English.

b. Upon completion of training the participant will be issued with an Authorized Training Certificate

c. Course duration is flexible and the contents can be modified to fit any number of days.

d. The course fee includes facilitation training materials, 2 coffee breaks, buffet lunch and A Certificate upon successful completion of Training.

e. One-year post-training support Consultation and Coaching provided after the course.

f. Payment should be done at least a week before commence of the training, to DATASTAT CONSULTANCY LTD account, as indicated in the invoice so as to enable us prepare better for you.