As a specialty pharmacy, we have a keen interest in supporting the clinical research process to ultimately help the patients we serve. Our clinical trial solutions include program customization that supports trial protocols while streamlining pharmacy processes.
Customized Investigational Pharmacy Program: We work with the principal investigator and the research team to customize a program to support specific needs of the study. We can:
Collaborate with trial sites
Create patient-specific labeling and custom forms
Offer custom data reporting
Support the post-launch clinical study in a variety of models (fee-for-service, commercial, blended, etc.)
Dispense in all 50 states and all U.S. territories
Fulfill oral, IV, and self-injectable formulations
Provide shipment tracking via pharmacy management system integrated with FedEx
Post-launch Interventional Trials: Our associates are experienced in patient monitoring and therapy adherence to ensure program recruit retention. On each interaction we have with a patient/study participant, we verify any changes in therapy, other medications being taken, any allergy profile changes, inquire about any side effects and ask how they are managed, and ask if the patient would like to speak to a clinician. We monitor these elements to ensure no new changes will adversely impact their therapy.
We have the capability and flexibility in our pharmacy management system to capture and track completion of risk evaluation mitigation strategies (REMS) and post-marketing requirements, including elements to assure safe use.
Inventory Management: Our inventory is perpetually managed in our pharmacy management system. Weekly cycle counts are conducted and full inventory counts are conducted quarterly. US Bioservices tracks all inventory at the lot level using 2-D barcoding technology. This same technology is utilized at dispense, final quality assurance check and shipping to ensure accuracy in order management.
All shipping packaging is certified by the manufacturer to maintain controlled cold temperatures while in transit to the patient for a period of 24-48 hours.
We can meet the standards in the 21 CFR Part 211 Subpart H for holding and distribution, and have written procedures for quarantine, storage of drug in correct temperature, humidity, and other conditions.