APEX

Advanced Protocol Execution (APEX) Clinical Supply Management (CSM) is designed to provide sponsors with an experienced clinical supply manager to manage their studies.

APEX CSM can be engaged for all levels of study management, from ongoing study maintenance to full study implementation and rollout. Forecasting, IRT development/maintenance, inventory management, etc.

Apex Scope

• APEX provides clinical trial management to oversee all Sponsor related clinical supplies activities from protocol maintenance to program setup and implementation
• APEX supports and aligns with sponsor management to meet additional internal project tasks
• APEX provides full aptitude to support the increase in supply demands within all trial phases
• APEX provides enhanced supply options including forecasting, packaging, distribution and daily supply tasks
• APEX provides improved efficient use of bulk supplies including active, placebo and ancillary supplies
• APEX provides the needed experience, expertise and exceptional customer service to support programs and projects at all levels

The Difference Between PM and APEX CSM

Function of Project Management

• Xerimis contact for general supply questions
• Packaging timelines
• Label Text & Translation
• Batch Record Creation & Execution
• Timeline Management
• Release & Distribution
• Production Campaigns
• Reviews packaging schedule to provide adequate feedback for packing timelines
• Provides packaging and supply updates to APEX
• Returns Accountability & Destruction

Function of APEX CSM

• Forecasts drug supply material
• Provides support for planning, facilitation, and management of sponsor meetings, external vendors, and IRT suppliers
• Provides support for protocol design, study design, kit design, label design/label text, distribution strategy, selection/procurement/management of all ancillary study supplies
• Provides IRT support (if required) and provide system configuration support when/if needed
• Procures, monitors, and manages comparator drug when necessary
• Responsible for supply inventory, management, budgeting, and maintenance of drug supply returns/destruction/accountability
• Tracks and resolves supply temperature excursions and cold chain management when needed
• Manages overall study activities, requests and manages quotes for all items relating to drug supply, monitoring of all US, EU and ROW supplies
• Provides dedicated continued efficient relationships with internal project management, external regulatory, and external manufacturing teams