CRO

The Jesús Usón Minimally Invasive Surgery Centre (CCMIJU) is a Contract Research Organisation (CRO), an international reference centre in translational research, minimally invasive surgery, technological development and
specialised training. Strategic partner in public and private R&D Projects.

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Regulatory framework

We have a Quality Assurance and Regulatory Framework department, designed to ensure the quality and integrity
of the data obtained in preclinical studies, carrying out audits in the different phases, audits of the facilities,
as well as audits of the internal processes related to the studies

1. TYPICAL PROCESS FLOW OF A GLP STUDY

2. GOOD LABORATORY PRACTICE CERTIFICATION

The centre is certified under the principles of Good Laboratory Practice (GLP) in the following areas of
certification:

In vivo toxicity
Toxicity in vitro
Tolerance::
- Dermal
- Ocular
Pharmacodynamics
Test product administration and specimen procurement
Biocompatibility of healthcare products

3. UNE-EN-ISO 9001:2015 CERTIFICATION

The CCMIJU has the AENOR UNE-EN-ISO 9001:2015 certification, which gives us optimal document management,
allowing us to identify and address the needs of our customers and implement strategies for continuous
improvement

4. ANIMAL WELFARE ETHICS COMMITTEE

The CCMIJU has its own Animal Experimentation Ethics Committee. It is accredited by the Regional Government
of Extremadura and recognised by the Ministry of Science, Innovation and Universities as an authorised
body for the evaluation of all kinds of projects in which experimental animals are used.

5. AAALAC ACCREDITATION

AAALAC International is a non-profit organization of internationally recognized prestige, dedicated to evaluating institutions that use animals for experimental and educational purposes. The aim of this accreditation is to ensure that these institutions adopt more humane practices and safeguard the welfare of the animals used in their activities. CCMIJU is currently actively working to obtain this accreditation in 2026.

6. CONSULTANCY

We offer a specialised consultancy service for the planning, design and execution of preclinical studies, focused
on ensuring product safety, scientific soundness and resource optimisation. Our multidisciplinary team
provides strategic support from the initial phase of development to the achievement of the scientific and
regulatory objectives of the project.

Facilities

ANIMAL HOUSING

SURFACE AREA OF 3200 m2
CAPACITY TO HOUSE SMALL AND LARGE ANIMALS
TRANSGENIC AREA
QUARANTINE, RECOVERY AND TREATMENT ROOMS

OPERATING THEATRES

8 SPECIALISED EXPERIMENTAL OPERATING THEATRES
GENERAL ANAESTHESIA EQUIPMENT
SPECIFIC EQUIPMENT FOR MINIMALLY INVASIVE SURGERY PROCEDURES:
- Laparoscopy
- Endoscopy
- Interventional radiology
- Microsurgery
ROBOTIC PLATFORMS (DA VINCI XI, SYMANI AND VERSIUS)
ADVANCED MEDICAL IMAGING EQUIPMENT:
- Half-arc fluoroscope
- Ultrasound scanner
- Resonancia magnética 3 Teslas (RMN)
- Digital radiography
- OCT (Ophthalmology and vascular)
- Laser speckle contrast analysis (LASCA)
INSTRON 6800 FOR BIOMECHANICAL TESTING
HIGH FIDELITY SIMULATED ROOMS AND HYBRID OPERATING THEATRE
NECROPSY ROOM
STERILISATION ROOM

SPECIALISED LABORATORIES

MAGISTRAL FORMULATION
CLINICAL ANALYSIS:
- Haematology, biochemistry, urinalysis, coagulation, specific biomarkers
CLINICAL ANALYSIS:
- Equipment of molecular biology techniques and biomarkers: ELISAs, qPCR, flow cytometry, fluorescence microscopy
- Cell culture rooms
CONFOCAL MICROSCOPY
ASSISTED REPRODUCTION:
- Equipment for in vitro fertilisation (IVF), ICSI, vitrification and devitrification of gametes and embryos and a time lapse system to evaluate embryo development.
MEDICAL PRINTING:
- Equipment for 3D printing: FDM, SLA, SLS
- Equipment for bioprinting and generation of scaffolds: micro-extrusion,
  droplet, DLP, electrospinning
- Equipment for manufacturing and characterisation of biomaterials: viscosimetry, rheometry, DMA, UV-Vis
- Proof of concept and analysis of bioprinted scaffolds and drug delivery
- Prototyping and improvement of bioprinting systems
- Prototyping for simulation and surgical planning
- Computational simulation of biomaterials

Preclinical studies

Our CRO specialised in IN VIVO preclinical studies, offers customised solutions for both regulatory (GLP) and non-regulatory projects, attending to your needs, from pilot studies and proof of concept to regulated studies, minimising the risks prior to the clinical phase.