preclinical & clinical services in musculoskeletal field
TRANSCRIPT
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2016
PRECLINICAL & CLINICAL TRIALS SOLUTION IN MUSCULOSKELETAL
DISEASES
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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…
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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
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ADDED VALUES
SCIENTIFIC EXPERTISE
REGULATORY SERVICES
CERTIFICATIONS
INNOVATIVE TOOLS
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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
Learn more
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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
Learn more
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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)
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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
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A DEDICATED TEAM
CRO TEAM
1 Clinical Manager
3 Clinical Research Associates
Network ofFlying Nurses
2 Technicians
2 Clinical Project Leaders
1 Imaging Leader
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OUR NETWORK OF INVESTIGATORS
More than 30 centres in France and Belgium (University) hospitals and private practice Rheumatologists, orthopedic surgeons, physiotherapists
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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
Learn more
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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)
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BIOMARKERS TESTING
ARTIALIS OFFERS A COMPLETE PORTFOLIO OF VALIDATED ASSAYS AVAILABLE FOR TESTING
BONE
OsteocalcinNTXI
CARTILAGE
Coll2-1CTXIIFibulin-3COMP
INFLAMMATION
Coll2-1NO2PGE2usCRPMPOHA
METALLOPROTEASES
MMP1MMP3
Learn more
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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