End-to-end management of
Clinical Trials
From medication procurement and storage to specialized logistics and patient reimbursement. Complete solutions delivered to the highest quality and safety standards.
Procurement, storage and traceability
This service is carried out by pharmacists and duly qualified professionals committed to excellence in clinical research.
Distefar manages the procurement, storage and traceability of investigational, control, concomitant and rescue medication in clinical trials. We have optimal facilities for the custody and storage of cytotoxics, narcotics, blood-derived products and temperature-sensitive medication.
We manage distribution to national and European sites through carriers accredited for medication at 15°C–25°C and 2°C–8°C. Distefar also operates its own certified fleet and acts as a contract warehouse.
Certified in GDP under RD 782/2013 and ISO 9001 and 14001. Ongoing training in GCP, GDP and GMP. Authorized to handle controlled substances since 2006 and holder of the Distefar Laboratory MIA 6787 authorization since 2023.
Patient expense reimbursement management
Distefar manages the reimbursement of patient expenses during the clinical trial, as well as payments for loss of productivity and inconvenience caused, as set out in Royal Decree 1090/2015 of 4 December, Art. 3h.
- Lower financial burden
- Reduced payment turnaround time
- We specify the exact day on which incurred expenses will be paid
- We remove a task that adds no value to the clinical process
- Savings in time, HR and financial costs
- We simplify accounting and legal oversight for audits
Medical device supply
A clinical trial does not involve medication alone. Medical devices support the diagnosis, monitoring and progress of patients.
Distefar supplies all types of materials for diagnosis and treatment: medical equipment, consumables and miscellaneous items, including drug and pregnancy tests.
All supplied materials meet Distefar's quality and safety standards, ensuring reliable results in every clinical trial.
Destruction of medication and materials
At Distefar we carry out, on behalf of our clients, the removal of medication, medical devices and consumables from research sites for destruction, issuing the corresponding certificate.
We manage collection at research sites and the destruction of all surplus trial materials, issuing the official destruction certificate.
Distefar performs the selective destruction of medication that requires it, such as cytotoxics, following specific environmental safety protocols.
Calibration of medical devices
Distefar organizes the calibration of medical devices, both those supplied through Distefar and those already present in hospitals, ensuring reliable results and accurate patient assessment.
We manage the calibration of both devices supplied through Distefar and those already in use within the hospital departments participating in the trial.
Calibration is performed using parameters certified by ENAC (the Spanish National Accreditation Body), ensuring reliable results in the assessment of trial patients.
Labeling and release of medication
Distefar carries out the labeling and release of investigational medication through an authorized Qualified Person (QP) and under laboratory authorization MIA 6787.
Labeling and release are carried out by a Qualified Person (QP) under laboratory authorization MIA 6787, ensuring regulatory compliance for every batch.
Distefar labels medication with the clinical trial reference (sponsor code), preventing mix-ups with medication already present in hospital pharmacy departments.
Import, blinding and placebo manufacturing
Distefar adds to its portfolio the import and blinding of investigational medication and the manufacturing of placebos, meeting the needs of its clients.
We manage the import of investigational medication in full compliance with all applicable regulations, facilitating access to the drugs needed to conduct the trials.
We carry out the blinding of investigational medication to ensure the correct conduct of double-blind trials, safeguarding the integrity of the process.
Distefar manufactures placebos under the strictest quality standards, continuing to advance in the field of research to keep expanding its portfolio of services.
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