The distribution of substances for clinical trials requires an understanding of the process that goes well beyond the requirements of the commercial supply chain. We speak your language when it comes to IMP, IVRS, sites, sponsors, CRO, monitoring, custody, and drug accountability.
All parties involved must have the same basic understanding to jointly define the functional logistics of a clinical study. We know the significance and documentation expense that each minor temperature deviation has for the execution of a clinical study, and we make sure in advance that these do not occur.
Utilize our competence and experience in the following areas:
- Import of unapproved pharmaceuticals under the Drugs Acts §6 und §14
- Documented release based on clinical requirements
- Qualified storage in the temperature ranges 15-25°C, 2-8°C, -15°C − -25°C as well as < -21°C
- Qualification of passive packing systems
- Monitored, temperature-contolled delivery of 15-25°C as well as 2-8°C goods to study centers throughout Europe
- Returns processing and documented disposal
- GMP manufacturing (secondary packaging)