synlab clinical trialYour full service provider

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 logis-

tics, 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 custo-

mers also benefit from the interdisciplinary

dialogue between bio-medical scientists of all

disciplines.

synlab‘s clinical trial department

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 com-plies 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 laborato-ries 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. 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 phar-maceutical products and the genetic make-up of patients treated using these products will progressi-vely lead to more effective drugs with fewer side-effects.

Our synlab network is equipped with highly experi-enced staff, providing this specialist analytical expertise in areas such as human genetics, molecu-lar 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. We undergo regular audits – not only internal, but also by pharmaceutical companies as well as regional and federal government authori-ties.

Our unified Quality Management system ensures that all our internal processes – including Data Management, laboratory work and so on – opera-te 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 partici-pants.

That’s the decisive factor

Accreditation standards:

• DIN EN ISO 17025

We have been accredited by

• DAkkS (Die Deutsche Akkreditierungs-stelle GmbH/The German Accreditati-on 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 Laboratori-umsmedizin (German association for clinical chemistry and laboratory medicine), Germany

• INSTAND Institut für Standardisierung und Dokumentation im medizinischen Laboratorium eV (Institute for standardi-sation and documentation in medical laboratories), Germany

• UK NEQAS, United Kingdom

• WEQAS, United Kingdom

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

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, prepa-ring results from trials in such a way that they can be easily trans-ferred 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.

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

GERMANY

GREAT BRITAIN

CZECH REPUBLIC

SLOVAKIA

ITALY

AUSTRIA

HUNGARYBULGARIA

ROMANIA

BELARUS

SWITZERLAND

CROATIA

SLOVENIA

UKRAINE

SAUDI ARABIA

UNITED ARAB EMIRATES

TURKEY

POLAND

MACEDONIA

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www.synlab.com

If you are interested in finding out more, please do not hesitate to call us on

+49 (30) – 39 60 85 13

synlab clinical trial GmbHcentral laboratory

Turmstr. 21 Haus M, Eingang OD-10559 Berlin

Germany

synlab clinical trial LtdFirst Floor Clearview House, 201

Pinner RoadNorthwood Hills HA6 1BX

UK

clinicaltrial@synlab.comwww.synlab.com/clinicaltrial