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WORLD CLASS LABORATORY SERVICES BIOANALYSIS & PATHOLOGY A NEW BREED WITH A LONG PEDIGREE


QUALITY ASSURANCE

PHASE I - IV

INTERNATIONAL MEDICAL MONITORING

DATA MANAGEMENT

INTERNATIONAL SITE MONITORING

REGULATORY AFFAIRS

MEDICAL & TECHNICAL WRITING

IMP MANAGEMENT

STRATEGIC SUPPORT

BIOSTATISTICS INTERNATIONAL PROJECT MANAGEMENT

PHARMACOVIGILANCE SAMPLE MANAGEMENT

PHASE I RESEARCH CAMPUS

BIOANALYTICAL LAB

PHASE I - IIa BIOMARKERS

PATHOLOGY LAB

MEDICAL SUPPORT

ASSAY DEVELOPMENT

SCIENTIFIC SUPPORT CLINICAL PHARMACOLOGY PROJECT MANAGEMENT

SCINTIGRAPHY & ADME STUDIES


BIOANALYTICAL & PATHOLOGY

SEIRIAN LABORATORIES, A NEW NAME WITH 3 DECADES OF EXPERIENCE, IS AN INTEGRATED ELEMENT OF THE SIMBEC-ORION GROUP - A TRULY FULL SERVICE, GLOBAL CRO WITH IN-HOUSE CAPABILITIES TO SUPPORT EVERY ASPECT OF YOUR CLINICAL DEVELOPMENT PROGRAM

SEIRIAN LABORATORIES SUPPORTS: • SIMBEC-ORION GROUP • BIOTECH AND PHARMA COMPANIES • OTHER CROs

TYPES OF CUSTOMER

6%

13%

32% Large Pharma Biotech & Mid Cap Pharma Academic Institutions CRO/Other

49%

“115,000 CLINICAL CHEMISTRY TESTS PER WEEK, FROM 5,000 SAMPLES”


BIO LABORATORY

BIOANALYTICAL SERVICES Seirian Laboratories is experienced in: • Developing and validating complex assays • Highly selective and sensitive methods • Supporting all types of clinical studies We continually: • Invest in the state of the art equipment to ensure we can deliver on our customer’s needs • Ensure that we apply the most appropriate analytical methods • Produce the highest quality data sets for your studies

STUDY MANAGEMENT Our dedicated project management staff coordinate the bioanalytical phases of your study and: • Logistics • Data management • Statistics We can coordinate either with your existing CRO or as part of an integrated study run by Simbec-Orion. All bioanalysis conducted in support of a study is directly managed by a highly experienced Principal Scientist, liaising with your clinical, pharmacokinetic or bioanalytical teams. 4

SEIRIAN LABORATORIES


FULL RANGE OF LC-MS & IMMUNOASSAY EQUIPMENT BIOTEK SYNERGY 96-WELL PLATE READER

API 5500 API 5000’S API 4000 API 365

RADIOISOTOPES LABORATORY Our Radioisotopes Laboratory performs radioactivity measurements for human ADME and mass balance studies. RadioHPLC and LC-MS/MS techniques are then used to investigate metabolite profiles and to assist the identification of putative metabolites. SEIRIAN LABORATORIES

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PATHOLOGY LABORATORY

SEIRIAN PATHOLOGY EXPERTISE Dedicated pathology support for international clinical trials. Designed exclusively for the biopharmaceutical industry with over 30 years of consistent, high quality delivery.

SEIRIAN LABORATORIES COMMITMENT OUR SERVICE OFFERING: • • • •

• • • • • • • • •

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Extensive range of analytical capabilities 7 Day per week Analyses ClinAxys LIMS 21 CFR part 11 compliance State-of-the-art fridge/freezer temperature monitoring system Rapid turnaround times Biomarker Services Internal QA support Pharmacokinetic and Pharmacodynamic analyses Logistics Management Visit-specific sample collection kits Protocol-specific pathology manual Project Management Data Management

SEIRIAN LABORATORIES

Our combined expertise, experience and investment in infrastructure Seirian Laboratories provide a: • Rapid • Responsive • Reliable service Committed to ensuring the prompt analysis and electronic transfer of results, helping our customers make critical decisions in a timely manner.

“37% OF SEIRIAN’S

EXPERIENCE HAS BEEN WITH NEW CHEMICAL ENTITIES...


“15,000 BLOOD COUNT

THERAPEUTIC AREA EXPERIENCE

SAMPLES PER WEEK”

REPRODUCTIVE MALE/FEMALE INFECTIOUS DISEASES ENDOCRINOLOGY RHEUMATOLOGY

7 day per week analyses

DERMATOLOGY IMMUNOLOGY RESPIRATORY METABOLISM CARDIOLOGY ONCOLOGY Logistics management

...INCLUDING TRANSFER OF TECHNOLOGY FROM PRECLINICAL TO HUMAN MATRICIES”

TECHNOLOGY Clinical Chemistry Biochemistry, Immunology, Serology, Drugs of Abuse Screening Haematology Full Blood Count with Differential Routine and Specialised Haemostasis Markers e.g. Thrombin Generation Assay Flow Cytometry Flow Cytometry - Lymphocyte Subset analysis etc.

Urinalysis Routine multi-parameter testing with microscopic analysis Multiplex Assays Cytokine Assays Laboratory Computer System Clinical Trial LIMS Freezer Storage Rees Scientific System Monitoring Storage Temperatures i.e. 4C, -20C, -80C and Room Temperature

Microbiology Bacteria Identification and MIC Susceptibility

SEIRIAN LABORATORIES

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SEIRIAN LABORATORIES BUSINESS DEVELOPMENT T A

ACCREDITATIONS UK GLP/GCP COMPLIANCE MHRA PHASE 1 CLINICAL TRIALS SUPPLEMENTARY ACCREDITATION CLINICAL PATHOLOGY ACCREDITATION UK EXTERNAL QUALITY ASSESSMENT SCHEME

+44 1443 690977 Simbec House Merthyr Tydfil Industrial Park, Merthyr Tydfil CF48 4DR United Kingdom

Info@SimbecOrionCRO.com

www. SimbecOrionCRO.com

100 Overlook Center 2nd Floor Princeton NJ 08540 USA

Simbec House Merthyr Tydfil Industrial Park Merthyr Tydfil CF48 4DR United Kingdom

7 Bath Road Slough SL1 3UA United Kingdom

Centre d’Affaires La Boursidière Bâtiment le Jura, BP 141 92357 Le Plessis-Robinson Cedex France

Via Boezio, 6 Cap 00193 Roma Italy

T +1 215 345 5004

T +44 1443 690977

T +44 1753 578080

T +33 1 40 83 40 83

T +39 328 03494

Seirian Laboratories Brochure  

World Class Laboratory Services Bioanalysis & Pathology A New Breed With a Long Pedigree.

Seirian Laboratories Brochure  

World Class Laboratory Services Bioanalysis & Pathology A New Breed With a Long Pedigree.