From Clinical to Approval

We utilize 40+ years of clinical trial experience to review your study’s protocol. We look at target areas, patient populations and demographics, along with the protocol’s unique attributes and requirements. A comprehensive study-specific plan is derived that meets your unique ancillary supply and equipment needs. Startup services include:

• Budget management
• Investigator meeting supplies and materials
• High-quality translation services
• Physician, site, and patient engagement materials
• Supply procurement
• Supplies delivery
• Equipment calibration compliance
• Storage and global allocation as needed by sites
• Labeling and packaging
• Kitting
• Site staff training

Cutting through international red tape is our specialty. We get your supplies to their global destinations on time through exclusive digital platforms and resources to stay on top of ever-changing compliance regulations, including:

• Customs
• VAT
• Duties
• Sales tax compliance
• Licensing for medical devices, textiles, dangerous goods
• Reporting on improvement
• Importer of record services

Our highly skilled project managers will help you keep your study on track with ongoing evaluations to anticipate future requirements. We are also skilled at stepping anywhere into your timeline for rescue situations. We specialize in patient recruitment, even when your study is not meeting enrollment. And we’re the best at procuring the right supplies and getting them to their international destinations. Management services include:

• Sunshine Act reporting
• Regulatory reporting
• Inventory management
• Supply and resupply
• Equipment maintenance, repair, and demand planning

Our team will help you wrap up all details and materials, including documentation, reporting, products, accountability, inventories, and review. Our expertise includes:

• Legal compliance
• Returns
• Resale
• Reconciliation
• Store and reuse
• Tax qualifying donations
• Confidential disposal/destruction
• Distribution of final patient data to sites