Controlled Drug handling Services
Above all else, CSM’s global distribution services are certified and registered in controlled drug handling, and we remain a client and patient-driven company.
In order to help our clients (and ultimately, their patients) with their specific clinical trial’s supply needs, CSM’s controlled drug handling services include five U.S. DEA registrations:
- Retail Pharmacy Service
We successfully complete annual DEA regulatory audits and all CSM employees are cleared by the DEA, allowing the highest level of quality, safety, and secure handling of your clinical supplies.
It is as vital to us as it is to you that we ensure DEA compliance is adhered to because of the rigorous rules and regulations around handling controlled drugs. In the EU, we ensure full compliance with national legislations covering the handling of controlled drugs.
Controlled drugs always make the clinical supply chain more complex and we fully understand that. CSM helps to ensure safety and compliance every step of the way so that your clinical trial will run smoothly.
As your global clinical trial supplies partner, we always maintain safe, agile, and compliant methods during your study with a personal focus on patient safety.
Additionally, to ensure your trial runs smoothly, careful planning is a main focus of CSM’s core methodology. We are always committed to providing you with innovative, customizable solutions that keep your trial running on time, on budget, and fully compliant in regards to any regulatory requirements.
Controlled Drug Handling Service Capabilities:
- Registered Controlled Drug Handling (CII - CV)
- CI Drug Products (upon request)
- DEA Vault, Safe, and Cage
- Temperatures: Controlled Room, Refrigerated, and Frozen
- Global Distribution of Controlled Drugs
- Import of Controlled Drugs
- Qualified Person (QP) Release
- Returns and Destruction
“I want to thank you for the great cooperation and your never-ending efforts regarding our global Phase II study. Even in difficult situations and in case of urgent issues CSM is supporting us, always trying to find a solution.”
Heike Schön, Clinical Research Consultant (external), Glycotope GmbH