Operationalize and Manage Trial and Comparator Drug(s)
We procure, store, dispense to, monitor inventory at, and dispose of unused drugs from each study site. We’ll work with your Principal Investigator and Trial Site Pharmacies to ensure the drugs are where they need to be when they need to be there.
Clinical Trial Management Team Partnership
We work alongside your CRO and entire clinical trial team from protocol planning and development, through FDA and IRB approvals, through prelaunch trainings, site launches, through the end of the study and beyond. We are available for additional services as needed throughout the trial.
Clinical Trial Sites Partnership
We establish and maintain solid working relationships with the Principal Investigators, trail site pharmacies, and entire trial teams at each study site.
Seamless Progression along Drug Approval Continuum from Clinical Trial to EAP to Commercial Drug
We maintain therapy continuity for subjects as access to drug expands to larger groups of HCPs. We plan for this on the front end so operations run smoothly at each transition.
Clinical Trial Data Reports
We collaborate with the Clinical Trial Team early in the process to ensure pharmacy data reports support exactly what the protocol requires.
Drug and Disease State Training
We will provide clinical training per the protocol, and drug administration training to subjects and caregivers as needed.
If any drug in the protocol requires REMS, we will operationalize into our processes and ensure complete compliance throughout the trial.