Services
Investigational
Product Management
All operations related to the management of Investigational Products are carried out under the responsibility and control of the Qualified Person (Pharmacist). This concerns human and veterinary investigational products such as medicines, medical devices, dietary products and food supplements.
PRODUCT SOURCING
• Research and purchase of any product necessary
for the conduct of your Clinical Trial:
Comparators, Auxiliary Products,
Medical Devices, Food Supplements
• Application for import authorisation
for the conduct of your Clinical Trial:
Comparators, Auxiliary Products,
Medical Devices, Food Supplements
• Application for import authorisation
LABELLING AND SECONDARY PACKAGING
• Design of packaging adapted to each study (patient kits)
• Development of label models
and packaging master
• Packaging at the required temperature
(ambient, refrigerated, under dry ice, etc.)
• Blinding with a resemblance jury
• Sample bank in accordance
with current regulations
• Development of label models
and packaging master
• Packaging at the required temperature
(ambient, refrigerated, under dry ice, etc.)
• Blinding with a resemblance jury
• Sample bank in accordance
with current regulations
CERTIFICATION
by the Qualified Person (Pharmacist)
by the Qualified Person (Pharmacist)
• Review of batch files
• Pharmaceutical Certification before
release by the Sponsor
• Pharmaceutical Certification before
release by the Sponsor
STORAGE AND DISTRIBUTION
with LINCKIA support
• Secure storage at the required temperatures according
to ICH standards (+15/+25°C, +2/+8°C, -30°C and -80°C)
• Monitoring of expiry dates by alert system
and automatic or on-demand resupply
• Dispensation to investigator sites upon request, automatic or emergency
• Control of the supply chain at all temperatures, traceability of transport temperatures
to ICH standards (+15/+25°C, +2/+8°C, -30°C and -80°C)
• Monitoring of expiry dates by alert system
and automatic or on-demand resupply
• Dispensation to investigator sites upon request, automatic or emergency
• Control of the supply chain at all temperatures, traceability of transport temperatures
DIRECT TO PATIENT
• Direct delivery to patients,
in accordance with the Study Protocol
in accordance with the Study Protocol
RETURN, RECALL AND CERTIFIED DESTRUCTION
• Return at the request of the Sponsor,
controls and registration
• Management of batch recalls in collaboration
with the Sponsor
• Destruction by incineration and issuance
of a certificate of destruction
controls and registration
• Management of batch recalls in collaboration
with the Sponsor
• Destruction by incineration and issuance
of a certificate of destruction
REGULATORY PROCEDURES
• Management of contacts with the Health Authorities
• Regulatory watch
• Carrying out audits of pharmaceutical
service providers on behalf of Clients
• Regulatory watch
• Carrying out audits of pharmaceutical
service providers on behalf of Clients