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IMPORT, STORAGE AND DISTRIBUTION
Importing drugs for clinical trials requires agility and knowledge of specific import procedures and regulatory aspects. When this service is contracted, your internal import area becomes freed from activities out of its routine, and the trial project receives a more adequate local assistance. |
At INTRIALS the CTMs (clinical trial materials) are handled by a department entirely dedicated to all import processes and issues, acting with responsiveness and providing total assistance to both the sponsor and the investigators. |
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 When drug IMPORTS is your challenge , INTRIALS takes charge of:
• All legal procedures, approvals and customs clearance;
• Delivery to destination center;
• Follow-up of all phases of the process;
• Strict control of clinical trial materials;
• Application of the GMP and GCP concepts to the investigational supplying process.
STORAGE AND DISTRIBUTION
INTRIALS provides complete and safe infrastructure for the storage and distribution of the drug in study, as well as for materials returns or destruction.
Storage
INTRIALS premises have ideal storage conditions, that observe all safety details and environmental variables. Installations, equipments, controls and personnel are in conformity with the most updated and rigorous concepts and technologies of clinical storage, to ensure a 24 hour integrity, confidentiality and disposal of the stock.
Distribution
The most adequate solution is proposed to each client, regarding his technical needs for packaging and temperature, according to GCP and GMP norms. INTRIALS puts in operation a logistic that covers the whole national territory, 24 hours a day, making possible emergency expeditions to be delivered in the same day. Client can follow each product delivery, from shipment to receiving confirmation. |
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INTRIALS infrastructure of storage and distribution includes:
• Restricted and controlled access;
• Remote Temperature monitoring;
• Backup generator, in case of drop of energy;
• Automatic temperature record, each 4 hours;
• Humidity recording and control;
• Security system against robbery, sunlight, vandalism and insects;
• Smoke detector;
• 24-hour video recording;
• All authorizations required by Brazilian legislation;
• Conformity to GCP and GMP norms, and to our internal SOPs;
• Guaranteed isolation, by client and by trial;
• Management and technical direction conducted by pharmacists.
• Absolute data confidentiality.
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| Contact us to access a presentation about the region and to learn more about how INTRIALS can assist you conduct studies in Latin America. |
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