Biomedical research is the set of systematic scientific processes that study human biology, disease and treatments with the aim of generating knowledge applicable to health. It ranges from laboratory studies on cells and genes through to clinical trials involving patients, and depends heavily on the support of specialist laboratories that guarantee the quality of samples and results. In Spain, biomedical research has become established as a scientific and economic driver, with a growing volume of projects across hospitals, universities, health research institutes (IIS) and biotechnology companies.
Key points
- Biomedical research combines basic science, clinical research and translational research to improve the diagnosis and treatment of disease.
- A biomedical research project usually goes through a preclinical phase and four clinical phases (I to IV) before becoming part of standard practice.
- Spain authorised 930 clinical trials in 2024, more than any other EU country, according to Spain’s Agency for Medicines and Health Products (AEMPS).
- The Biomedical Research Act (Law 14/2007) governs the use of biological samples, biobanks and the ethics committees that oversee every project in Spain.
- Services such as cytogenetics, molecular biology and biobanks form the technical backbone that underpins biomedical research from within the laboratory.
- Choosing an accredited laboratory partner with a broad test catalogue and R&D experience speeds up the timelines of any study.
What biomedical research is and the types that exist
In legal terms, biomedical research is any scientific activity related to human health that involves the use of biological samples, genetic analysis or invasive procedures for the purpose of generating knowledge, as set out in Spain’s Biomedical Research Act (Law 14/2007). This framework distinguishes three broad categories within biomedical research:
- Basic research: explains biological, cellular and genetic mechanisms without immediate clinical application, laying the groundwork for future treatments.
- Clinical research: evaluates medicines, devices or procedures directly in patients through controlled clinical trials.
- Translational research: connects laboratory findings with real-world clinical practice, shortening the path between discovery and treatment.
Institutions driving biomedical research rarely work alone: they need an external partner to process samples, look after biobanks and provide technical reports. This is the role played by Ambar Lab’s R&D collaborations in clinical research with research centres, hospitals and biotechnology companies.
Phases of a biomedical research project
Every biomedical research project aimed at a new treatment goes through a sequence of regulated phases, each with its own objectives and timescales:
| Phase | Main objective | Approximate duration |
|---|---|---|
| Preclinical | Test hypotheses in the laboratory, cell cultures and animal models before moving on to humans. | 1 to 4 years |
| Phase I | Assess safety and the tolerated dose in a small group of volunteers. | 1 to 2 years |
| Phase II | Measure initial efficacy and adjust the dose in a larger group of patients. | 2 to 3 years |
| Phase III | Confirm efficacy and safety in thousands of patients, comparing against the standard treatment. | 2 to 4 years |
| Phase IV | Monitor long-term safety once the treatment has already been authorised and is on the market. | Ongoing |
Each phase of biomedical research calls for specific laboratory analysis: from baseline genetic studies through to quality control of the biological samples collected at every trial visit.
Spain, a European benchmark in biomedical research
Spain has established itself as the most active European country in biomedical research. According to ICEX Invest in Spain, citing the Spanish Agency for Medicines and Health Products (AEMPS), the country authorised 930 clinical drug trials in 2024, ahead of countries such as France and Germany, with cancer accounting for more than a third of all studies.
Alongside this, the Carlos III Health Institute (ISCIII), Spain’s main public funder of health science, dedicated more than €192 million in 2025 to health R&D&I and has accredited 36 health research institutes (IIS) across the country. This public network underpins much of the academic and translational biomedical research that is later transferred to hospitals and companies.
The role of cytogenetics and molecular biology
A large part of biomedical research depends on detecting chromosomal or genetic alterations before moving on to later phases. This calls for techniques such as karyotyping, fluorescence in situ hybridisation (FISH) or CGH arrays, which can identify numerical and structural chromosome abnormalities.
When a project works with cell lines cultured in vitro, stem cell cytogenetics makes it possible to monitor the chromosomal stability of the culture over time. This is complemented by molecular biology, which provides sequencing and fragment analysis techniques that are essential for any biomedical research line focused on genetic or hereditary disease.
Biobanks: the foundation of translational biomedical research
A biobank is, under the Biomedical Research Act, a non-profit public or private establishment that holds a collection of biological samples organised to quality standards for diagnostic or biomedical research purposes. In Spain, every biobank must be registered with the National Registry of Biobanks and have a scientific and ethics committee that authorises the release of each sample.
Biobanks are especially important when working with stem cells, whether from bone marrow, peripheral blood or umbilical cord, since long-term storage allows them to be reused in future projects. This same logic explains the recent progress of regenerative medicine, which relies on reliable access to well-characterised samples to develop cell and gene therapies.
How to choose a laboratory partner for your biomedical research project
Not every laboratory is equipped to support a biomedical research project from design through to the final report. At least these criteria are worth weighing up:
- Broad test catalogue: having an extensive test catalogue avoids relying on several suppliers for the same study.
- Accreditation and clinical experience: a clinical diagnostic laboratory with an established healthcare track record provides assurance on quality and traceability.
- Logistical support: sample collection at the research centre itself and turnaround times adapted to the project’s schedule.
- R&D track record: previous experience working alongside researchers, not just a one-off testing service.
Frequently asked questions about biomedical research
What is biomedical research?
Biomedical research is the body of scientific studies that examine human biology, disease and treatments with the aim of improving health. It ranges from basic laboratory science through to clinical trials with patients, and is regulated in Spain by the Biomedical Research Act (Law 14/2007).
What are the phases of a biomedical research project?
A biomedical research project goes through a preclinical phase, in which hypotheses are tested in the laboratory or in animal models, followed by four clinical phases (I to IV) that assess safety, efficacy and long-term safety in people.
What is a biobank and what role does it play in biomedical research?
A biobank is an establishment that holds human biological samples organised to quality standards for use in research. In Spain it must be registered with the National Registry of Biobanks under the Biomedical Research Act.
What legislation governs biomedical research in Spain?
Biomedical research in Spain is governed mainly by the Biomedical Research Act (Law 14/2007), which sets out the requirements for the use of biological samples, genetic analysis, biobanks and research ethics committees.
Why does Spain lead biomedical research in Europe?
Spain leads biomedical research in Europe thanks to its hospital network, accredited ethics committees and strong patient recruitment rates. In 2024 it authorised 930 clinical trials, more than France, Germany or Italy.
Which laboratory tests are commonly used in biomedical research?
Biomedical research regularly draws on karyotyping, fluorescence in situ hybridisation (FISH), CGH arrays and molecular sequencing to detect chromosomal or genetic alterations in study samples.
How long does a biomedical research project typically take?
Duration varies with the phase and complexity of the project: the preclinical stage can take 1 to 4 years, while the full set of clinical phases usually runs for 6 to 10 years before final approval.
How does an external laboratory support a biomedical research project?
An external laboratory supports biomedical research by processing samples, carrying out genetic or cytogenetic analysis, looking after biobanks and providing technical reports that back up the results before ethics committees and regulatory agencies.
Take your next biomedical research project forward with the right laboratory partner
Biomedical research moves faster when the laboratory processing the samples and genetic data is part of the team from day one. At Ambar Lab we support research centres, hospitals and biotechnology companies with more than 3,000 tests, cytogenetics, molecular biology and biobank management. If your institution needs a partner for its next biomedical research project, get in touch with our team and tell us about it.
