Controlled Drug Services

Ensuring safety and compliance every step of the way

Above all else, Clinigen’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, Clinigen’s controlled drug handling services include five U.S. DEA registrations:

• Manufacturer
• Importer
• Exporter
• Distributor
• Retail Pharmacy Service

We successfully complete annual DEA regulatory audits and all Clinical Supplies Management 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 legislation covering the handling of controlled drugs.

Controlled drugs always make the clinical supply chain more complex, and we fully understand that. Clinigen Clinical Supplies Management 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 one of the main focuses of Clinigen’s core methodology. We are always committed to providing you with innovative, customisable 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)
• DEA Vault, Safe, and Cage
• Global Distribution of Controlled Drugs
• Import of Controlled Drugs
• Qualified Person (QP) Release
• Returns and Destruction