During the course of running an international clinical trial there are many potential challenges related to getting the various materials to and from the appropriate destination on time and with the correct labelling in the appropriate language.
Handling all this competently requires full knowledge of the local regulations and import/export licensing procedures as well as tracking of updates issued by the relevant authorities and departments.
We employ people with appropriate pharmaceutical and clinical trial experience to support all logistic activities. The value of local knowledge in these countries cannot be understated. On-the-ground experience is highly important in order to get materials – be they investigational products or documents such as protocols, CRFs or submission dossiers – to the right place, correctly labelled and without frustrating administrative delays.
We can organise and implement the preparation (where appropriate), transport and delivery of all clinical trial materials.
In summary we can:
- Provide accurate country-specific advice on labelling requirements for Investigational Medicinal Products/clinical supplies
- Provide any necessary translation services for country-specific documents
- Procure insurance coverage in accordance with applicable requirements
- Procure import licenses for investigational products, associated supplies and equipment
- Procure export licenses for biological samples
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