Phase II-IV Clinical Studies

This unit offers all the Laboratory services (new biomarkers, routine laboratory, checking/development of analytical methods, etc.) which are primary or frequent in drug clinical study protocols. The unification and standardisation of the results are highlighted as important values: Phase II is focused on testing the concept; Phase III emphasises effectiveness and safety compared with the best available treatment before a drug goes on the market; and Phase IV is based on after-sale studies of effectiveness, safety and efficiency/effectiveness studies to evaluate a drug.

In addition, the unit also offers support and advice in designing the protocol, logistics for preparation (standard kits or ones adapted to the client's needs) and sample transport (by own messenger or preferred supplier), data processing and the report (carried out by IT staff individually assigned to each project) and interpretation of the analytical results.

Analytical profiles, kits and logistics adapt to the client's specific needs/study protocol and are perfectly integrated into laboratory operations.

Each step in the sample processing procedure is designed to ensure their integrity and traceability, offering open communication and results as quickly as possible.

The presence of Echevarne as a clinical analysis laboratory at various hospital and non-hospital centres makes it easier to establish cooperative networks with specialist clinics to carry out projects (from phase II to phase IV) with different indications.

SERVICES:

  • Central laboratory in multi-centre tests:

Safety analysis
Effectiveness analysis

  • Participation in researchers' meetings
  • Organization of the collection and priority transportation of samples
  • Sending extraction kits and instructions for researchers on how to take samples
  • Notification of pathology results to CRO's, researchers and promoters
  • Monthly summaries of the progress of the study
  • Statistical analysis of results
  • Electronic data transmission to the promoter in the same format for all centres
  • All sample handling and analysis following Good Laboratory Practice (GLP)
  • Clinical nutritional studies