The management of clinical trial materials is a complex, specialized skillset. Our subject matter experts have extensive experience managing all aspects of a broad range of clinical trials, from small single-center Phase I trials to large, international Phase III trials. Jeiven helps you achieve control of your clinical trial supply chain and guide you in best practices for clinical supplies from both GCP and GMP perspectives that meet US and EU expectations. Whether it be on an individual task level, or managing all aspects of the supplies for a protocol or entire program, we can assist with the following activities:

• Project management
  • Select and oversee contract service providers
  • Manage the quote/proposal process with service providers
  • Coordinate activities with Clinical Study Team
• Planning and forecasting
  • Protocol level, accounting for sufficient extra for distribution strategy and inevitable changes (e.g., additional sites, slower or faster enrollment rates, etc.)
  • Program level, aggregating demand across studies for more efficient supply planning
• Design packaging and labeling specifications
  • Tailored to a single protocol or standardized to suit multiple studies in a program
  • Designs anticipate the needs of the customers—both the site staff conducting the study and the patients using the medication
• Documentation development
  • Authoring the clinical supplies section of a study protocol
  • Authoring the Drug Supplies Manual
  • Developing forms for ordering, accountability, reconciliation, or returns, as needed
  • Creating presentation materials for Investigator’s Meeting
• Label development
  • Master text and layout, adhering to all regulatory requirements
  • Coordinate translations and certifications, if required
  • Coordinate proof approval
• Distribution Strategy development
  • Manual versus IRT, as appropriate
  • Single depot, regional depots, or multiple sub-depots for global trials
  • Recommend appropriate shippers and temperature monitors
• IRT System development
  • Assist in development of User Requirements Specifications
  • Assist in conducting User Acceptance Testing
  • Manage inventory and distribution setting for optimal performance
• Link Clinical Supplies to CMC
  • Provide supply-related documents for IND or IMPD filing
  • Coordinate expiry extensions with stability studies
  • Recommend stability studies
  • Outline supply chain and appropriate alternates for QP Declarations
• Import/Export support
  • Common trip points: HTSUS codes, FDA drug codes, valuation, invoice review
  • Coordinate import licenses with CROs or service providers
  • Manage USDA import permits
• Adjudication of temperature excursions
  • During transport or on-site
  • Rapid response to minimize impact to sites
  • Follow your excursion guidance, or assist in the development of appropriate guidance

We can provide on-site customized clinical supplies training. Click here to learn more.