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2016
PRECLINICAL & CLINICAL TRIALS SOLUTION IN MUSCULOSKELETAL
DISEASES
WHO WE ARE
CRO SPECIALIZED IN MUSCULOSKELETAL DISEASES OFFERING PERSONALIZED SOLUTIONS FOR PRECLINICAL STUDIES AND CLINICAL TRIALS…
… BRIDGING THE GAP BETWEEN PRECLINICAL AND CLINICAL DATA WITH INNOVATIVE TOOLS OF VALIDATION
… PROVIDING SCIENTIFIC EXPERTISE AND OUTSTANDING RESEARCH SERVICES…
WHO WE ARE
Founded in 2010 as a spin-off of the University of Liège, Belgium
Customers include large and mid-size pharmas, biotech, medical device and academic research organizations
Portfolio preclinical studies and clinical trials in drug/complement development (phase I/II, II, IV) and medical device (class II, III)
Phase IV
Phase II
Phase I/II
Preclinical
Portfolio of studies
Drug Medical device Food complement
ADDED VALUES
SCIENTIFIC EXPERTISE
REGULATORY SERVICES
CERTIFICATIONS
INNOVATIVE TOOLS
PRECLINICAL STUDIES
TAILOR-MADE SOLUTION
ANALYSIS OF YOUR NEEDS
FIRST, WE MEET!
STUDY DESIGN
•Animal model•Time line•Treatment administration
•Biomarkers
IN-LIFE PHASE
•Clinical follow-up
•Blood sampling•Surgery •Imaging•Treatment administration
EX-VIVO EXPERIMEN
TS•Macroscopy•Histology
ANALYSE AND
STATISTICS
REPORT
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PRECLINICAL STUDIES IN OSTEOARTHRITIS
ANIMAL MODELS• Rat, rabbit, guinea pig• Induced OA model• Spontaneous OA model
STUDY ENDPOINTS• Gold standard endpoints• Macroscopy• Histology
INNOVATIVE TOOLS• Biomarkers• CatWalk• Mach 1
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FACILITIES
Visit the Novalis Science Center
Technical accesses outside the area Hermetic and decontaminable area HVAC-Pressions Airlock H202
SPF animal facilities High capacity of accomodation (mice, rats, guinea pigs, rabbits)
CLINICAL TRIALS
PROTOCOL WRITINGREGULATORY ACTIVITIESKOL EXPERTISE
INNOVATIVE TOOLS
SITE SELECTION & MONITORINGDATA MANAGEMENT & STATISTICSFINAL REPORT
TAILOR-MADE SOLUTION
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Disease/Structure modifying product
Symptom-modifying product
CLINICAL TRIALS IN OSTEOARTHRITIS
CLINICAL OUTCOMES IN OA EMA guidelines on clinical trial in OA (CPMP/EWP/784/97 Rev.1.2010)
Biomarkers
Imaging
Soluble biomarkers
Pain & Function
WOMAC, KOOS, VAS
A DEDICATED TEAM
CRO TEAM
1 Clinical Manager
3 Clinical Research Associates
Network ofFlying Nurses
2 Technicians
2 Clinical Project Leaders
1 Imaging Leader
OUR NETWORK OF INVESTIGATORS
More than 30 centres in France and Belgium (University) hospitals and private practice Rheumatologists, orthopedic surgeons, physiotherapists
IMAGING BIOMARKERS
Biochemical composition of cartilage (dGEMRIC, delayed Gadolinium enhanced MRI of cartilage): information about the content of proteoglycans in cartilage knee.
WORMS (Whole-Organ Magnetic Resonance Imaging Score) assigns a multiple scores to each structure of the joint.
Examples of evaluation
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BIOMARKERS TESTING
BIOMARKER IS CLASSICALLY DEFINED AS A CHARACTERISTIC THAT IS OBJECTIVELY MEASURED AND EVALUATED AS AN INDICATOR OF NORMAL BIOLOGIC PROCESSES,
PATHOGENIC PROCESSES, OR PHARMACOLOGICAL RESPONSES TO A THERAPEUTIC INTERVENTION.
(BIOMARKERS DEFINITIONS WORKING GROUP, CLIN PHARMACOL THER 2001;69:89-95)
BIOMARKERS TESTING
ARTIALIS OFFERS A COMPLETE PORTFOLIO OF VALIDATED ASSAYS AVAILABLE FOR TESTING
BONE
OsteocalcinNTXI
CARTILAGE
Coll2-1CTXIIFibulin-3COMP
INFLAMMATION
Coll2-1NO2PGE2usCRPMPOHA
METALLOPROTEASES
MMP1MMP3
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WHERE WE ARE
ARTIALIS IS LOCATED INSIDE THE UNIVERSITY HOSPITAL OF LIÈGE
+32 4 242 77 27
ARTIALIS s.a11, Avenue de l'HôpitalTour GIGA +34000 Liège (Sart-Tilman)Belgium
