Clinical Trials Phase II-IV
This unit offers all the services of the central laboratory (new biomarkers, routine laboratory, validation/development of analytical methods, etc.) that are fundamental or frequent in protocols of Clinical Trials for drugs. Unification and standardisation of results are particularly important values:
Phase II
Focuses on the Proof of Concept
Phase III
Emphasises efficacy and safety versus the best available treatment before marketing a drug
Phase IV
Based on post-marketing studies of efficacy, safety and efficiency/effectiveness to evaluate a drug.
Likewise, the Unit also offers support and advice in the design of the protocol, logistics for preparation (standard kits or kits adapted to the client’s needs) and the transportation of samples (by the laboratory’s own courier service or using a preferred provider), data management and the report (devised by computer staff individually assigned to each project) and interpretation of the analytical results. Analytical profiles, kits and logistics are adapted to the specific needs of the client/protocol of the study, and are perfectly integrated into the laboratory’s operations.
Each step in the process of handling the samples is designed to ensure their integrity and traceability, offering transparent communication and maximum speed in the results.
The presence of Echevarne Laboratory as a clinical analysis laboratory in several in-patient and out-patient centres makes it possible to establish cooperative networks with clinical specialists in order to carry out projects (from phase II to phase IV) in different areas.
Services
- Central laboratory in multicentre trials:
- Analysis of safety
- Analysis of efficacy
- Participation in researcher meetings
- Organisation of the urgent collection and transportation of samples
- Sending extraction kits and sampling instructions for the researcher
- Notification of pathological results to CROs, researchers and promoters
- Monthly summaries of the evolution of the study
- Statistical analysis of results
- Electronic transmission of data to the promoter in the same format for all centres
- Nutritional clinical trials
