Level of Service I

Clinical Supplies Project Management

• Oversight of labeling and packaging operations

• Management of distribution from depot to depot and to clinical sites

• Coordination of returns and destruction activities

Project Execution & Oversight

• Development and management of project timelines

• Creation and tracking of manual and IRT-based distribution orders

Clinical Site Management

• Management of clinical site returns

• Oversight and coordination of product destruction

Level of Service II

Includes all Level of Service I activities, plus:

Strategic Planning & Forecasting

• Strategic planning and forecasting for Investigational Medicinal Products (IMPs)

• Strategic planning and forecasting for Non-Investigational Medicinal Products (NIMPs)

• Strategic planning and forecasting for ancillary supplies

Packaging & Labeling Strategy

• Development of overall packaging and labeling strategy

• Expiration date management and oversight

• Creation of label text, including single-panel, multi-panel, and booklet formats

• Coordination with client regulatory teams for label text review and approval

• Collaboration with labeling vendors on draft review and final label approval

• Coordination with client regulatory teams for label submission to regulatory authorities

IRT & Systems Oversight

• Review and approval of IRT specifications

• Execution of IRT User Acceptance Testing (UAT)

• Documentation and reporting of UAT pass/fail results

Inventory & Quality Management

• Clinical supply inventory management at depots

• Management, documentation, and resolution of clinical supply temperature excursions at depots and clinical sites

Level of Service III

Includes all Level of Service I and Level of Service II activities, plus:

Governance & Stakeholder Engagement

• Participation in Study Team meetings

• Participation in vendor and partner meetings, including CROs, labeling and packaging vendors, IRT providers, and other service partners

Vendor Selection & Financial Oversight

• Development of Requests for Proposal (RFPs) based on clinical supplies strategy

• Review and comparison of vendor proposals

• Preparation of scope-of-work summaries and cost assessments to support client vendor selection

Clinical Site & Pharmacy Documentation

• Drafting of pharmacy manuals

• Collaboration with client clinical teams to finalize and approve pharmacy manuals

• Delivery of pharmacy manual training to clinical sites

Blinding & Study Integrity

• Management of unblinding activities in coordination with CROs, site personnel, and unblinded statisticians

Quality Systems & SOP Development

• Drafting of Standard Operating Procedures (SOPs)

• Collaboration with client GMP/Clinical Quality Assurance teams to finalize, implement, and maintain SOPs

Level of Service IV – Advanced / Inspection Readiness Support

Includes all services from Level I–III, plus:

• Inspection Readiness & Preparation

  • Lead preparation for audits and regulatory inspections related to clinical supplies

  • Conduct comprehensive review of all clinical supply documentation for inspection readiness

• Mock Inspection Support

  • Participate in and support mock inspections

  • Identify gaps, risks, and areas for improvement

• Inspection Execution

  • Serve as Clinical Supply Subject Matter Expert (SME) during regulatory inspections

  • Provide real-time support, clarification, and documentation as requested by inspectors

• Inspection Closeout

  • Participate in inspection closeout meetings

  • Support interpretation of inspection outcomes and observations

• Post-Inspection Support

  • Provide strategic recommendations to address inspection findings

  • Collaborate with client QA and legal teams to develop and finalize responses to regulatory agencies

  • Support timely and effective resolution of findings to achieve client satisfaction