Management of medication for clinical trials
- Acquisition and storage of medication:
This service is performed by pharmacists and duly qualified professionals seeking excellence in clinical research.
Distefar manages the acquisition, storage and traceability of medicines in research, control, concomitant and rescue in Clinical Trials.
Distefar has optimal facilities to ensure the custody and preservation of the different types of medicines (cytotoxic, narcotic, blood products, thermolabile, ...).
Distefar manages the preparation, storage and specialized distribution of medication for randomized double blind clinical trials.
- Logistics and distribution:
Distefar manages the distribution of the medicines requested to national and European research centers through accredited and certified transport companies to handle medications at both 15ºC-25ºC and 2ºC-8ºC (thermolabile) temperatures. Distefar also has its own fleet homologated.
Likewise, regarding the investigational medicines that the promoters provide us for Clinical Trials, we take care of the storage and distribution of these.
In all these processes, Distefar carries out an exhaustive control of the traceability of all medicines and health products.
- Store by contract:
Distefar is authorized by AEMPS to perform the Contract Store service for investigational drugs. From where the reception, storage, custody, conservation and distribution to the different research centers are made.
- Quality and Safety:
At Distefar, we are certified in the European Directive of Good Distribution Practices (BPD), of November 5, 2013, according to RD 782/2013 of October 11, as well as with international quality standards ISO 9001.
At Distefar, we receive continuous training in Good Clinical Practices (BPC) and Good Distribution Practices (BPD).
Our warehouse has, since 2006, the authorization of management, storage and distribution of controlled substances.
Management of reimbursement of expenses to patients
Distefar carries out the Management of reimbursement of expenses to patients during the clinical trial as well as the payments for lack of productivity and discomfort caused, collected in the last Royal Decree 1090/2015 of December 4, Art. 3 h.
What benefits do we bring ?:
For the patient:
- Lower financial burden.
- Reduction of collection time.
- We indicate exactly the day you will be charged for these expenses.
For the promoter:
- We eliminate a task that adds nothing to the clinical process, freeing up time for more productive tasks.
- Cost in time, rrhh and financial.
- We facilitate control by the center and the promoter.
- We facilitate accounting and legal control by delegating the process.
What we get?
- A greater adherence of the patient to continue in the trial
- Tranquility of the promoter
- Legal and accounting security before audits of sanitary and hacienda inspections.
Supply of medical devices
In the development of a clinical trial, not only drugs intervene.
Other medical devices collaborate in the diagnosis, monitoring and evolution of patients.
Supply of medical devices
Distefar provides for the diagnosis and treatment, all kinds of material, which includes everything from medical equipment, consumables, etc., to drug tests and pregnancy.
With the quality and safety of Distefar.
From Distefar, we perform for our clients, the withdrawal of medicines, medical devices and consumables from the research centers, for their destruction, issuing the certificate of the same.
Distefar performs a selective destruction of those medications that require it.
Calibration of medical devices
Distefar organizes the process of calibration of medical devices both those acquired through Distefar, as well as those existing in hospitals, thus ensuring a guarantee in the results and assessment of the patients participating in the Clinical Trial.
The development of the calibration is carried out using the parameters certified by the ENAC.
Import and labeling of medication
Distefar, performs the import, release and labeling of the investigational drugs through (Qualified person) QP authorized.
Distefar also provides the Labeling of medicines with the reference of the clinical trial to which it belongs (Promoter Code), in order to avoid the crossing of control, concomitant and rescue medicines designated for the clinical trial with those already existing in the hospital pharmacy services.
Masking. Placebos manufacturing
Distefar incorporates into its service portfolio the masking of investigational drugs, as well as the manufacture of Placebos, thus satisfying the needs that our clients demand.
We continue to make progress in the field of research, expanding our portfolio of services to satisfy our customers.