- Services Overview
- Biorepository/Biobanking Overview
- Cell Therapy Services
- Laboratory Overview
- Storage/Transport of Bio-API
- Kit Production/Clinical Trial Support
- Qualification / Validation Services
- News/Press Releases
Clinical Site Support
Our experts will assist with study design and set-up, create a study manual, and present at Investigator’s meetings, if needed.
We can assist with Health Insurance Portability and Accountability Act (HIPAA) compliance and patient consent forms.
Our clinical site support includes our direct-to-patient/direct-to-site pharmacy services. Our pharmacy in Rockville, MD, is licensed in all 50 states and has a Drug Enforcement Agency (DEA)-approved storage area. Our current good manufacturing practice (cGMP)-trained registered pharmacists and pharmacy technicians can support clinical trials, phase I - IV studies, Patient Assistance Programs (PAP), Early Access Programs, and distribution of specialized low-volume medications.
We can monitor drug use by sites, track agents at the item level, conduct product recalls in compliance with 21 Code of Federal Regulation (CFR) 211.150(b), Distribution procedures, and process returns in compliance with 21 CFR 211.204, Returned Drug products.