Supply Chain

Our consultants support clinical programs across the full spectrum of strategy and execution. Many engagements begin with hands-on operational support and can be complemented by targeted strategic assessments and roadmaps.

Strategic services include:

• Clinical supply chain gap and operating model assessments
• Strategic roadmaps aligned to development plans and trial complexity
• Scenario planning to address enrollment uncertainty, protocol changes, and scale transitions

Operational services include:

• Clinical supply planning, forecasting, and inventory management
• IRT setup, script execution, UAT, and ongoing trial support
• Packaging, labeling, shipment coordination, depot oversight, and returns
• End-to-end management of clinical supply operations without diverting internal scientific resources

Similar to clinical supply chain, commercial supply chain engagements often begin with a strategic assessment and evolve into execution through launch and early commercialization.

Strategic services include:

• Commercial supply chain operating model and gap assessments
• Commercial supply chain strategy and roadmap development
• Make-buy decisions, virtual vs. integrated supply chain models, and investment timing

Operational services include:

• Activation and execution of the commercial supply chain during launch
• Ongoing supply, inventory, and S&OP process support
• Coordination across CMOs, 3PLs, quality, and commercial stakeholders

We help clients design, implement, and operate fit-for-purpose supply chain and operational processes, with flexibility to engage at the strategic design level, the execution level, or both.

Strategic services include:

• End-to-end process design and mapping
• Definition of roles, responsibilities, and RACIs
• Development of guidance documents and conceptual operating models

Operational services include:

• Drafting SOPs and work instructions
• Supporting or running processes such as supplier risk monitoring, capacity planning, or materials management
• Continuous improvement of live operational processes

Engagements typically begin with a focused strategic assessment and transition into long-term operational support.

Strategic services include:

• Global logistics and trade compliance gap assessments
• Evaluation of import/export practices, cold-chain readiness, and compliance risk
• Development of global logistics and trade compliance strategies and roadmaps

Operational services include:

• Acting as the client’s logistics and trade compliance function
• Day-to-day import/export execution for DP, DS, API, and R&D materials
• Building and maintaining trade compliance infrastructure, procedures, and supplier relationships
• Cold-chain and cryogenic logistics solution design and shipping qualification

We support the business side enablement of enterprise system initiatives without acting as a technical integrator.

Strategic services include:

• IT landscape and system assessments
• Solution selection for ERP, QMS, EDMS, serialization, COI/COC, MES, and analytics
• Business and user requirements definition

Operational support includes:

• Project management and PMO support during system implementations
• Test script creation, execution support, and UAT coordination
• Cross-functional coordination alongside third-party integrators

For clients currently without internal leadership in this domain, our senior experts can provide interim expertise and hands-on leadership with the goal of enabling the clients to identify, hire, and onboard internal candidates in a timely manner.

We oversee your project to achieve your milestones in a timely fashion, including maintaining up-to-date project timelines, organizing project team meetings, capturing meeting minutes, establishing RACI (responsible, accountable, consulted, informed) matrices, and following up on achievement of action items.