Clinical trials are an essential part of the development of new drugs, therapies, and healthcare technologies, contributing to improved quality of life and life expectancy, as well as the development of safer and more effective treatments worldwide.
Clinical trials drive the creation of research networks by connecting institutions, fostering the exchange of knowledge, and standardizing scientific collaboration on a global scale, which in turn enables the generation of high-quality evidence. Furthermore, these activities can be certified as R&D&I projects, providing access to tax deductions and legal certainty instruments such as the Binding Reasoned Opinion (IMV).
Clinical trial certification has thus become a strategic tool for laboratories, biotechnology companies, and CROs seeking to maximize the financial return on their research activities and strengthen the technical traceability of their projects.
At ACERTA, an organization specializing in R&D&I certification, a significant portion of the certified projects are clinical trials.
What are clinical trials?
Clinical trials are planned experimental studies conducted in humans to evaluate the efficacy and safety of drugs, therapies, diagnostic techniques, or medical procedures. They are considered the clinical research with the highest level of scientific evidence.
A clinical trial is defined as:
- A treatment plan is assigned to the patient in advance.
- Administration of the medication is a requirement for participation in the study.
- Additional diagnostic or follow-up procedures are performed in addition to standard clinical practice.
Operational phases of a clinical trial
The first part of the study design includes the definition of the treatment regimen, the patient population and sample size, inclusion and exclusion criteria, and the design of the documentation. This establishes the protocol and the clinical procedure to be followed to ensure regulatory compliance and the proper definition of the research objectives proposed in the project.
The second phase involves trial development and analysis of results, beginning with obtaining approval from regulatory agencies, followed by trial monitoring—the phase involving the greatest scientific uncertainty, in which, after years of preliminary research dedicated to defining the treatment’s characteristics, these are put to the test under real-world clinical conditions. Clinical trial monitoring ensures that the study is conducted in accordance with the protocol, regulatory requirements, and applicable quality standards.
Its main functions include:
- Monitoring the proper implementation of the protocol.
- Verification of clinical data.
- Document traceability control.
- Incident and deviation management.
- Coordination between sponsors and clinical centers.
What is clinical trial certification?
Clinical trial certification is a technical evaluation process that allows certain clinical activities to be recognized as R&D&I projects, thereby facilitating access to tax deductions and the Binding Reasoned Report (IMV).
This process evaluates the scientific and technological nature of the project, as well as the documentary and technical traceability of the activities carried out.
Clinical trial certification enables:
- Claim R&D&I tax credits with greater legal certainty.
- Obtain the Binding Reasoned Report.
- To provide technical accreditation for innovative activities.
- Improve the project's traceability and document control.
- Maximize the tax benefits associated with clinical research.
Why can clinical trials be classified as R&D&I?
Clinical trials involve systematic research activities aimed at generating new scientific knowledge and validating innovative healthcare solutions.
For this reason, all phases of a clinical trial —including the preclinical phase and Phases I–IV—can be classified as R&D&I activities.
This certification enables companies in the pharmaceutical and biomedical sectors to access significant tax benefits and strengthen the technical and documentary compliance of their projects.
Tax benefits of classifying clinical trials as R&D&I
The classification of clinical trials as R&D&I activities offerssignificant benefitsfor laboratories, sponsors, and CROs.
Reasoned Binding Opinion (RBO) for Clinical Trials
The IMV is a document issued by the Ministry of Science, Innovation, and Universities that provideslegal certaintyregarding the application oftax deductions for R&D&I.
Legal certainty
Anindependent technical assessmentstrengthens the strength of the documentation and reduces risks in the event of potentialtax audits.
Tax Benefits for CROs
In certain projects involvingforeign developers, domestic CROs may also benefit from thetax deduction schemeassociated with R&D&I activities.
Improved traceability and document control
Certification requires thattechnical evidence,regulatory documentation, andclinical research activities be properly organized.
Stages of a certifiable clinical trial
Clinical trials are conducted to address unmet medical needs and are based on extensive research to identify the drug, therapy, or diagnostic techniques—among other options—to be evaluated in this type of research project. All phases of a clinical trial may qualify as R&D&I activities.
| Phase | Objective | Participants |
|---|---|---|
| Preclinical | Initial Assessment and Toxicity | In vitro and animal studies |
| Phase I | Safety and Dosage | 20–100 people |
| Phase II | Efficacy Assessment | More than 100 patients |
| Phase III | Clinical confirmation | More than 300 patients |
| Phase IV | Pharmacovigilance | Patients in commercial use |
Preclinical phase
This includes animal studies, toxicity testing, and drug formulation prior to human trials.
Phase I: Safety Assessment
It evaluates the safety of the treatment and identifies tolerable doses and major adverse effects.
Phase II: Efficacy Assessment
It aims to determine whether the treatment is effective and to identify the optimal dose for patients.
Phase III: Clinical Comparison
It confirms clinical results in large populations and compares the treatment with existing alternatives.
Phase IV: pharmacovigilance
It assesses long-term effects and monitors safety after the drug is marketed.
Clinical Trial Monitoring: Key Roles and Responsibilities
Clinical monitoring is key to ensuring the scientific and regulatory reliability of the study.
It begins with the identification, evaluation, approval, and preparation of research centers, hospitals, clinics, and other entities that meet the requirements to care for the patient population that will participate in the clinical development of the therapy or drug under study.
This is followed by the evaluation and recruitment of patients who meet the inclusion criteria and do not meet any of the exclusion criteria, and continues with the monitoring of treatment administration and the recording of results.
The study concludes with an evaluation of the results obtained and the drawing of conclusions from the study.
In general, a clinical trial includes:
Preparatory stage
- Development of the protocol.
- Design of the Data Collection Form (DCF).
Regulatory phase
- CTIS-EudraCT Application.
- Regulatory submissions and CEIm.
Start of the trial
- Selection of centers.
- Contracts and initial visits.
Development and monitoring
- Patient recruitment.
- Monitoring of clinical trials.
- Pharmacovigilance.
Study closure
- Shutting down databases.
- Analysis and publication of results.
Which companies can benefit from clinical trial certification?
Clinical trial certification is particularly important for:
- Pharmaceutical companies.
- Biotechnology companies.
- Domestic and international CROs.
- Clinical research organizations.
- Companies engaged in biomedical innovation.
In all these cases, certification helps strengthen technical traceability and optimize the economic return on research activities.
ACERTA and Clinical Trial Certification
ACERTA is an independent organization specializing in certification, verification, and technical assessment with over 20 years of experience.
In the field of R&D&I:
- He has more than 10 years of experience certifying innovation projects.
- It is accredited in more than 70 technological disciplines.
- It has a high acceptance rate for favorable reasoned decisions.
In addition:
- More than one in three certified projects are clinical trials.
- More than 2,000 clinical trials have been certified.
- More than 270 million euros certified by IMV.
Conclusion
R&D&I certification for clinical trials provides technical validation of clinical research activities as pharmaceutical R&D projects, facilitating access to tax deductions and the Binding Reasoned Opinion. For laboratories, biotechnology companies, and CROs, this certification has established itself as a strategic tool for maximizing the return on investment in innovation and strengthening the legal certainty of their projects.
Questions Frequently Asked Questions
- It is a technical evaluation process that allows clinical activities to be recognized as R&D&I projects in order to qualify for tax incentives and legal certainty mechanisms.
- Yes. All phases, including preclinical and Phases I–IV, can be classified as R&D&I.
- This is a report issued by the Ministry that provides legal certainty regarding the application of tax deductions related to R&D&I activities.
- Yes. In certain situations, particularly in projects involving foreign sponsors, domestic CROs may claim tax deductions related to certified activities.
- Yes. Follow-up, monitoring, and pharmacovigilance activities are part of the technical aspects of the clinical trial.