synlab clinical trial

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Sybil Terry
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1 synlab clinical trial Your full service provider

synlab s clinical trial department synlab clinical trial (SCT) provides a full service for all types of drug development projects with pre-clinical and clinical CRO services, central clinical

This includes data management and evaluation, biometrics and statistics, medical writing, and finally archiving, all in accordance with the relevant and applicable GCP, GMP and GLP regulations.

2 synlab s clinical trial department synlab clinical trial (SCT) provides a full service for all types of drug development projects with pre-clinical and clinical CRO services, central clinical laboratory services, bioanalytical services, biomarker testing, personalised medicine concepts, sample logistics, long-term sample storage services, software development and validation. This includes data management and evaluation, biometrics and statistics, medical writing, and finally archiving, all in accordance with the relevant and applicable GCP, GMP and GLP regulations. We are part of the synlab Group, one of Europe s leading companies in laboratory diagnostics for human and veterinary medicine, and environmental analysis services. Operating as synlab clinical trial, our customers also benefit from the interdisciplinary dialogue between bio-medical scientists of all disciplines.

Central lab lab centre One of our clinical laboratories specialised in clinical trials is located in London, UK.

the various laboratories with the customer facilities.

Arabia and Dubai. In all our clinical trial laboratories we set up uniform technical configurations following the same high quality management rules.

3 Central lab lab centre One of our clinical laboratories specialised in clinical trials is located in London, UK. Our lab centre is located in the German capital and complies with the highest of analytical demands Berlin is also the organisational headquarters of synlab clinical trial, where we coordinate all of the various laboratories with the customer facilities. This central lab is supported by more than 80 specialised clinical and bio-analytical laboratories in 21 countries throughout Europe, extending through Turkey into Arabian Emirates such as Saudi Arabia and Dubai. In all our clinical trial laboratories we set up uniform technical configurations following the same high quality management rules. synlab stands for synergies : The powerful network of synlab s international laboratory services provides us with logistical support as well as the best actual scientific expertise. Our services: Supporting all stages of drug life cycle Preclinical analytics Phase I IV studies GAMP V software development fully 21 CFR part 11 compliant All benefits of a Central lab, provided peripherally Unique methodology and QM throughout all labs GMP/GLP services Data management Of course, Organisation of sample transport Service twenty four hours a day, seven days a week, three hundred and sixty five days a year Barcode recording for samples, and comparison with the trial-specific database Information on findings immediately after validation and many more go without saying.

Pharmacokinetics pharmacogenetics The principle of dose and effect has been known since the days of Paracelsus. Two questions will influence the use of medications in the future: 1.

Any pharmaceutical research company will tell you that research is the best medicine.

4 Pharmacokinetics pharmacogenetics The principle of dose and effect has been known since the days of Paracelsus. Two questions will influence the use of medications in the future: 1. How do substances change as a result of human metabolism? 2. What impact does a patient s genetic make-up have on the effect of medication? Any pharmaceutical research company will tell you that research is the best medicine. Increasing awareness about the kinetics of pharmaceutical products and the genetic make-up of patients treated using these products will progressively lead to more effective drugs with fewer sideeffects. Our synlab network is equipped with highly experienced staff, providing this specialist analytical expertise in areas such as human genetics, molecular biology and oncogenetics. Our aim is to make a significant contribution to healthcare and healthy aging. The SCT Competence Centres cover: Bioanalytics and Pharmacokinetic Analyses (LC-MS/MS, HPLC, GC, GC-MS, ELISA, RIA...) Cellular Biomarkers (real-time PCR, quantitative PCR, expression profiling, small RNA analytics, Flow Cytometry, Multiplex/Luminex, LTT, EliSPOT...) Pharmacogenetic Analyses (SNP-Analytics, High Resolution Melting, Biochip Analyses...)... and of course all clinical laboratory methods

Quality assurance Quality assurance is an essential part of managing clinical trials.

Our unified Quality Management system ensures that all our internal processes including Data Management, laboratory work and so on operate on the basis of the

Assuring quality however means more than just compliance with statutory regulations: we are responsible to our clients and our study participants.

Accreditation Body) UKAS United Kingdom Accreditation Service We participate in the quality assurance schemes of the following organisations: DGKL Deutsche

5 Quality assurance Quality assurance is an essential part of managing clinical trials. We undergo regular audits not only internal, but also by pharmaceutical companies as well as regional and federal government authorities. Our unified Quality Management system ensures that all our internal processes including Data Management, laboratory work and so on operate on the basis of the same and very high quality standard. We are working according to GCP, GLP and GCLP standards. Assuring quality however means more than just compliance with statutory regulations: we are responsible to our clients and our study participants. That s the decisive factor Accreditation standards: DIN EN ISO We have been accredited by DAkkS (Die Deutsche Akkreditierungsstelle GmbH/The German Accreditation Body) UKAS United Kingdom Accreditation Service We participate in the quality assurance schemes of the following organisations: DGKL Deutsche Vereinte Gesellschaft für Klinische Chemie und Laboratoriumsmedizin (German association for clinical chemistry and laboratory medicine), Germany INSTAND Institut für Standardisierung und Dokumentation im medizinischen Laboratorium ev (Institute for standardisation and documentation in medical laboratories), Germany UK NEQAS, United Kingdom WEQAS, United Kingdom

People serving people We have scientists, medical researchers, doctors, engineers and highly qualified medical assistants to ensure a consistently high level of analytical quality in our laboratories.

databases, or simply relieving our partners of some of the responsibility involved in a clinical laboratory trial.

6 People serving people We have scientists, medical researchers, doctors, engineers and highly qualified medical assistants to ensure a consistently high level of analytical quality in our laboratories. But service means much more to us: For example, being there to answer our client s questions, preparing results from trials in such a way that they can be easily transferred into our clients databases, or simply relieving our partners of some of the responsibility involved in a clinical laboratory trial. And last but not least: Our solid base of medical and technical know-how and two decades of experience in the sector. Since 1993 SCT has contributed substantially to more than 1800 clinical trials. Analytical Profile Pharmacogenomics Pharmacokinetic Biomarkers Molecular Pathology/DNA-RNA Tests Flow Cytometry Clinical Chemistry Haematology Immunology Infectious Disease Serology Auto-Immune Profiles Endocrinology Radioimmunoassays Therapeutic Drugs Toxicology Transfusion Microbiology Parasitology

Subsidiaries of synlab lab services Our broad international structure gives us the ability to

Moldavia Poland Romania Saudi Arabia Slovenia Slovakia Switzerland Turkey Ukraine United Arab

7 Subsidiaries of synlab lab services Our broad international structure gives us the ability to support your multicentre study, while synlab s logistical network ensures professional sample transport across borders. Austria Belarus Bulgaria Croatia Czech Republic Dubai Germany Great Britain Hungary Italy Macedonia Moldavia Poland Romania Saudi Arabia Slovenia Slovakia Switzerland Turkey Ukraine United Arab Emirates SLOVAKIA POLAND CZECH REPUBLIC GERMANY BELARUS GREAT BRITAIN UKRAINE AUSTRIA SWITZERLAND HUNGARY BULGARIA SLOVENIA CROATIA ITALY ROMANIA MACEDONIA TURKEY SAUDI ARABIA UNITED ARAB EMIRATES

If you are interested in finding out more, please do not hesitate to call us on +49 (30) 39 60 85

21 Haus M, Eingang O D-10559 Berlin Germany synlab clinical trial Ltd First Floor Clearview House,

8 If you are interested in finding out more, please do not hesitate to call us on +49 (30) synlab clinical trial GmbH central laboratory Turmstr. 21 Haus M, Eingang O D Berlin Germany synlab clinical trial Ltd First Floor Clearview House, 201 Pinner Road Northwood Hills HA6 1BX UK clinicaltrial@synlab.com D _14_Clinical-Trial