Global Project Management Expertise

Clinical trial sponsors face complex decisions related to product development. For our clients, packaging isn’t one of them. We’ve overseen packaging for thousands of clinical trials worldwide. Our insights, gained through years of experience, produce optimal outcomes aligned with trial objectives and applicable regulations.

Xerimis project managers (PMs) examine protocol requirements and work with you to develop the right strategy. They’ll produce a detailed design, labeling, and production timeline to achieve your desired outcome.

Our project management services are customizable, offering the following:

• Blinding services
• Randomization generation
• Kit design (including component selection and label design)
• Translation sourcing
• Compliance
• Comparator sourcing
• Procurement of ancillary supplies
• Packaging and supply strategy
• IVRS/IWRS consultation
• IVRS/IWRS interface
• On-demand labeling
• Timeline creation and management
• Vendor management

With Xerimis PMs you get transparency, expertise, and exceptional customer service. They’re the best in the industry and a key component of clinical trial success.

Optimizing Your Clinical Supplies Through APEX®

APEX® (Advanced Protocol Execution) from Xerimis is designed to provide you with an experienced clinical supply manager who can support your studies to any extent that you need. APEX® services can be engaged for clinical supply management at any level, from maintenance of a single US-only protocol to full program setup and global implementation. Regardless of how you use APEX®, our services will prove highly effective in optimizing your clinical supplies.

You’ll find APEX® particularly valuable if your clinical supply team is understaffed, dealing with increased responsibility, or handling complicated trial designs. We can support any part or all of your clinical supply activities, including strategy development and implementation, forecasting and inventory management, vendor selection and liaising, and more. Along with experience, we bring comprehensive knowledge of ever-shifting industry regulations. You may not always know the latest changes in the countries where your trial is running, but you can rest assured that we do. 

All stakeholders benefit when clinical trials run smoothly in the most cost-effective way. Your APEX® clinical supply manager will work with you and your internal teams as closely, or as independently, as you would like, always in alignment with sponsor goals. As with all Xerimis teams, APEX® staff adheres to the highest standards in customer service and quality of deliverables.

Highlights of Available APEX® Services:

• Assist in protocol development, including trial design and dosing regimens
• Forecast clinical supply needs: active, placebo, and ancillary
• Manage overall supply strategy and budget 
• Devise strategy for optimizing pooled supplies across clinical programs
• Establish distribution strategy of finished kits to depots; monitor and resupply global inventories
• Secure vendor quotes, aid in vendor selection, and manage vendor relationships
• Recommend comparator and ancillary supplies; source, procure, and manage resupply activities
• Facilitate IRT development and user testing; liaise with IRT vendor as needed for ongoing support
• Propose concept for overall packaging and labeling of patient kits
• Provide label support including text development and guidance on design, placement, and type
• Manage study closeouts including returns, accountability, and destruction activities
• Support cold chain supplies; track and resolve supply-temperature excursions
• Serve as point-of-contact with vendors, CROs, and investigators; assist with sponsor meetings