A SOLUTION TO BE CONSIDERED IN YOUR CLINICAL DISTRIBUTION PLAN
Managing Direct To Patient shipments in a decentralized clinical trial
Direct-to-Patient (DtP) is an integrated supply chain system that enables patients to receive treatment in their own home.
DtP also includes patient sample collection and return management. These services are often required in parallel and might be considered Direct-from-Patient (DfP) solutions.
IMPs/IPs can be shipped from an investigational site or from a depot.
IMP(s) are directly shipped from the warehouse* to the patient’s home, office or vacation destination. Returns are arranged from patient’s home to the warehouse*.
* CREAPHARM or one of its 40 partner depots
Project Leader Distribution
at CREAPHARM CLINICAL
While DtP has proven its advantages, it remains a complex logistic pathway, requiring expertise and flexibility
The Dt/fP distribution strategy must be described in the submission dossier and authorized by Competent Authority(ies).
Patient must have consent to disclose his/her personal contact details for delivery purpose
Regulations governing DtP vary worlwide. For instance:
Good Distribution Practices apply when managing Direct To Patient shipment. Thus, temperature monitoring is handled through the supply chain to guarantee cold chain management and consequently IMP/IP integrity.
When IMP/IP are sent from site to patient home, patient confidentiality is ensured by the hospital and carrier. CREAPHARM or any depot only manages a unique patient number. Managing a Depot to Patient shipment means dealing with a shipment without knowledge of the patient address.
Once again, local regulation impacts data confidentiality management. The carrier must be compliant for data preservation and destruction operations.
at CREAPHARM CLINICAL
«A local depot partner is necessary while dealing with regulatory challenges varying worlwide »
Giving Patient access to investigational drugs while staying at home
Reducing costs and storage at clinical sites
Increasing patient enrollment and retention
Gaining access to a wider patient population
Reducing patient trips to clinical sites
Providing each sponsor with tailormade solutions for both packaging & logistic operations
Deadline commitment to meet the patient needs
Full Traceability to guarantee
patient safety by IMP/IP integrity
The right logistics solution for clinical distribution in each clinical trial
Efficient & reliable logistic pathway
Regulatory advice shared by the CREAPHARM’s experts and partners.
A strong depot network bringing local support for operations and regulatory country specificities
A dedicated Clinical Supply Manager supported by specialists