Clinical trials constitute the fundamental pillar of the development of new treatments, allowing for the evaluation of their safety, efficacy, and applicability in humans under a highly demanding regulatory framework.

They are structured into different phases—from the first administration in humans (Phase I) to evaluation in real clinical practice (Phase IV)—each with specific scientific objectives and ethical requirements. The correct execution of these phases is critical both for the validity of the results and for the protection of participants.

Our firm offers highly specialized expert advice in the field of clinical research, providing independent, rigorous, and technically sound analyses in judicial and extrajudicial proceedings.

The reports are prepared by professionals who actively participate in conducting clinical trials, which provides direct and up-to-date knowledge of real clinical practice, as well as a deep understanding of the methodological, regulatory, and ethical aspects involved.

This approach allows for a comprehensive evaluation of clinical trials in all their phases with a multidisciplinary and evidence-based perspective.

We intervene in the preparation of expert reports in situations that require a high degree of specialization, including:

• Expert evaluation of the methodological quality and scientific validity of the clinical trial, including assessment of the specific drug’s mechanism of action.
• Analysis of compliance with current regulations and Good Clinical Practice (GCP), which includes evaluating when a side effect occurs.
• Review of the informed consent process and patient safety guarantees.
• Assessment of adverse events and causality analysis in relation to the treatment under study.
• Evaluation of the performance of investigators, sponsors, CROs, and participating centers.
• Analysis of the causal relationship of the alleged adverse effect with the medicine or medical device subjected to the clinical trial.

*According to the Spanish Agency for Medicines and Medical Devices (Last update: December 29, 2025)

A clinical trial with medicines is research conducted on people, intended to study the efficacy and safety of a drug. The objective of these studies is to obtain data confirming that the benefit/risk balance is positive for a given therapy, in order to subsequently request marketing authorization for the medicine.

Clinical research goes through several phases, in which the study populations progressively increase:

• Phase I: few participants (dozens), who may be healthy volunteers depending on the pathology under study, to confirm that the administration of the drug is safe.
• Phase II: efficacy analyses begin in a population that can reach 200-300 people, with safety at the explored doses being another primary objective.
• Phase III: confirmation of the drug’s efficacy in thousands of participants with the aim of obtaining data for a marketing authorization application.
• Phase IV: long-term studies with already authorized medicines to study rare adverse reactions or identify potential additional benefits.

The AEMPS is the competent authority in Spain for issuing authorization for clinical trials with medicines. However, it should be noted that the review of the different scientific-ethical aspects of the study is carried out in a coordinated manner between the AEMPS and the Ethics Committees (CEIm).