Interlabcentral lab services worldwide

LABRESULTSYOUCANTRUST

ROUTiNE ANALYTiCAL SERviCES safety panels and hematology immunology and serology oncology and endocrinology genetics and PCR microbiology and bacteriology histopathology and cytology

CUSTOmizEd ANALYTiCAL SERviCES PBmC cell separation assay development method validation pharmacogenomics rapid processing of largerbatches

QUALiTY SERviCES extended sample storage auditing of third party laboratories cross-validation with local labs

STUdY-SPECifiC SERviCES visit-specific kit building kit re-supplies within 2 days worldwide shipping logistics customized data management secure online access to data

GLOBAL STRENGThS one single database identical lab reports worldwide customized flagging global quality assurance one contact eases communication

COmPETiTvE PRiCiNG due to economies-of-scale

NORTh AmERiCA

AUSTRALiA

ASiA/ChiNANEAR ANd middLE EAST

iNdiA

hEAdQUARTERSGERmANY

SOUTh AmERiCA SOUTh AfRiCA

ABOUT US

COmPANY miSSiONiNTERLAB is a leading provider of regional, international, and global central laboratory services for clinical trials run by Pharma and Biotech companies. iNTERLAB fosters the development of our staff and conducts all services with the highest quality and ethical standards.

COmPANY hiSTORY: 18 YEARS 199420121994 iNTERLAB is founded in munich, Germany.1995 first global studies initiated in North and

South America, South Africa and Australia.1996 Setup of a global method cross-validation

procedure for data comparability.1998 Certified member in the German CRO Association.2005 New iT platform iLAB-World 21CfR part 11 compliant.2006 first studies initiated in China and india.2010 interface with several eCRf specialists.

GEOGRAPhiC COvERAGEiNTERLAB is uniquely qualified to support clinical trials in and outside Europe via an experienced laboratory network. Comparable methods, identical global reference ranges and units, and an integrated global database are keys to our sponsors satisfaction.

PROjECT mANAGEmENT

dEdiCATEd PROjECT SUPPORTAt iNTERLAB motivated and professional scientists provide sponsor-customized support for each clinical trial. This approach forms the basis of the high efficiency and quality of all our study support activities.

hence, clinical monitors, CRAs and investigators have a single iNTERLAB contact in either the USA or in Germany: a dedicated project director who is assisted by as many project managers as required. Our project teams ensure timely setup and efficient project management.

A typicAl dAy for iNtErlABs projEct mANAgErs

north & South amerIca europe & afrIcaHQ muNicH, gErmANy

aSIa auStralIa

08:00 cet preparation of activities for today; call team in Australia 16:00 shanghai 17:00 melbourne

10:00 cet meet client in munich; trigger kit delivery in Asia 17:00 singapore 19:00 sydney

08:00 Argentina 12:00 cet telcon with Buenos Aires; release manuals for india 16:30 delhi

11:00 chile, Brazil 14:00 cet finalize agenda for investigator meeting in latAm

10:00 New york 16:00 cet telcon with East coast; coordinate European tasks

09:00 california 18:00 cet video-conference with sponsor in san francisco

20:00 cet last lab reports for this day printed; data files sent

ThE AdvANTAGE Of iNTERLABS GEOGRAPhiC LOCATiON

Interlab

Take advantage of iNTERLABs centrally located central lab.

iNTERLAB is optimally situatedin order to support global clinical trials.

A key aspect for succeeding in multinational trials is the ability to communicate between different time zones without having to wait for the next day.

This ability of iNTERLAB ensures rapid communications and avoids delays in the processes.

8 7 6 5 4 3 2 1 0 + 1 + 2 + 3 + 4 + 5 + 6 + 7 + 8 + 9 + 10 + 11 + 12

STUdY SUPPORT ACTiviTiES

STUdY-SPECifiC SERviCES:

technical consultation e. g. during protocol development participation at investigator meetings worldwide shipping logistics pre-printed, site specific airway bills

visit-specific kit building kit re-supplies within 2 working days monitoring of kit stability bar-coded labels for positive specimen identification

customized data management one single database identical lab reports worldwide customized flagging

secure online access to data extended frozen sample storage method setup and validation global quality assurance

Study

Study 3

iLAB-WORLdiNTERLABS GLOBAL dATABASE

SiTES

dATA fiLES LAB

REPORTiNG

SPONSOR CRO

ONLiNE ACCESS

CRAs, mONiTORS, QA

Study 2

STUdY 1

country 1country 2country 3country ...

continent 1

iNTERLABtesting for continent 1

site 1site 2site 3site ...

country 1country 2country 3country ...

continent 2

iNTERLABtesting for continent 2

site 1site 2site 3site ...

country 1country 2country 3country ...

continent 3

iNTERLABtesting for continent 3

site 1site 2site 3site ...

country 1country 2country 3country ...

continent ...

iNTERLABtesting for continent ...

site 1site 2site 3site ...

iNTERLAB STUdY SETUP kick-off meeting finalize work order adapt global SOPs attend investigator meetings

iLAB-WORLd GLOBAL dATABASE 21CfR part 11 compliant same database worldwide real-time data consolidation secure online access

iNTERLAB SiTE SUPPORT project team coordinates tasksand monitor expiry dates of kits

sites collect samples usingvisit-specific kits

iNTERLAB PLANNiNG pre-print airway bills study-specific lab manuals visit-specific kits for sites harmonize global activities

iNTERLAB LOGiSTiCS sites call couriers & refer to manual couriers bring samples to iNTERLAB procedures are iATA compliant dry-ice is provided where needed

iNTERLAB LAB WORK harmonized methods worldwide methods are cross-validated global QA standards established broadest testing portfolio

iNTERLAB RESULT REPORTiNG queries resolved automatically customized lab reports flagging eases handling at sites successful study completion

GLOBAL REACh

OUR dELivERY PARTNERS

EUROPE:ECONOmiES-Of-SCALE iNTERLAB pairs the technology and the advantage of economies-of-scale of its reference laboratory, an independent business division with some 300 staff and 15,000 samples/day, with the flexibility and responsiveness of its clinical trials division to deliver the high quality and cost-effectiveness sponsors deserve.

ThE WORLd: A TRUSTWORThY GLOBAL NETWORK WiTh 11 LAB LOCATiONS Global reach is available via our laboratory network with over 10,000 staff and 300 specialists dedicated to supporting clinical trials in North and South America, South Africa, Near and middle East, Australia, Asia (via offices in Singapore and Shanghai) and india. Periodic audits and cross-validations ensure data combinability through test correlations and evaluation of data accuracy and precision.

iNTERLAB: EffiCiENT iNTERNATiONAL COORdiNATiON The project team allocated to a global study has itsoffices either in Germany or in the USA depending onwhere the lead sponsor is located. This dedicated team supervises and monitors all global activities and is the sole contact to sponsor.

TRANSPORTATiON: KEY TO iNTERLABS RELiABiLiTY Our project managers plan each single material and sample shipment upfront in order to avoid disappointing surprises. Professional courier companies have been identified following a tough selection process. This effort has resulted in highly reliable and cost-efficient outbound and inbound transportation procedures. Upon request, dry-ice and iATA compliant insulated boxes are provided to sites. Extended storage of frozen biological samples is also available at iNTERLAB.

GLOBAL QUALiTY ASSURANCE

QUALiTY COmmiTmENTiNTERLAB guarantees that all clinical trials worldwide aresupported by continuously trained professionals who knowthe importance of complying with SOPs and other qualitystandards implemented. Our global QA team supervisesall activities and directly reports to top management.

QUALiTY WORLdPeriodic audits of all laboratory facilities are performedby our QA team. Rigorous cross-validation ensurescomparability of international lab results in iLAB-World,iNTERLABs integrated global database.

QUALiTY ASSOCiATiONiNTERLAB is a certified member of the German Associationof CROs, BvmA, and was successfully audited by AdAmASin 2000, 2003 and 2006 and by verdandi in 2009.

ACCREdiTATiONS/ CERTifiCATiONS

Biorad quality control systemBvmA audited membershipCAP, College of American Pathologists CEmiC ArgentinaCLiA complianceiNSTANd quality control scheme iSO 14000 iSO 9001 Tv RheinlandiSO 9002diN EN iSO 15189diN EN iSO/iEC 17025NATA accreditationNEQASNGSP Program (Level ii)NYSdoh, New York State dept. of healthThistle quality assurance

QUALiTY iNTERACTiONiNTERLAB has established global SOPs for study setupand support and for data management and reporting.in addition to ongoing internal and external quality control,we can show appropriate accreditations equivalent toCAP or diN/iSO 15189.

QUALiTY LOGiSTiCSLogistics managers with valid iATA certifications ensurethat all sample shipments comply with valid laws andregulations worldwide and that only appropriate, validatedpackaging is always used.

dATA ANd iNfORmATiON mANAGEmENTin 2005 iNTERLAB introduced iLAB, a new iT platform compliant with 21 CfR part 11 requirements. iLAB enables lab reports all over the world to display the identical layout, content and flagging criteria.

iLAB hAS ExCELLENT KEY fEATURES:

BEST USABiLiTY ANd iNdividUALizATiON high level of customization result blinding; individualized flagging bar-coded labels for all specimens automated missing data collection

GLOBAL iNTEGRATiON global reference ranges global alert criteria identical for each study iLAB-Web for worldwide communication iLAB-freeze: frozen samples storage iLAB-Report: identical layout of lab reportsin all regions

hiGh LEvEL SECURiTY iLAB-Gate: secure online access iLAB-QA: electronic audit trail redundant backup technology disaster recovery plans

iNTERLABS iNTEGRATEd GLOBAL dATABASE:iLAB-WORLd

AAddiction studiesAllergy testing

BBacteriologyBiomarkersBlood products

CCardiovascularClinical chemistryCNS disordersCoagulationCytochrome P450Cytogenetics

ddermatologydiabetesdiagnostic immunologydrug analysis

EEndocrinology

ffiSh technologyflow cytometryforensic toxicology

GGastroenterologyGC-mS/mSGenetics

hhaematologyhistopathologyhPLC

iihC (immunohistoChemistry)immunologyimmune modulation LTT or NKinfectious diseases

LLC-mS/mSLipid profiles

mmens healthmetabolic disordersmicrobiologymolecular diagnosticsmycology

NNeurology

OOncologyOphthalmologyOsteoporosis

PParasitologyPBmC cell separationPCR & dNA amplificationPsychiatry

RRespiratory diseases

SSerology

TTherapeutic monitoring

UUrology

vvaccinesvirology

WWomens healthWound healing

SELECTiON Of ThERAPEUTiC AREAS

fOR fURThERiNfORmATiONviSiT OUR WEBSiTEWWW.iNTERLAB.dE

hEAd OffiCE: BAYERSTR. 53, 80335 mUNiCh, GERmANYTEL +49 89 7413930, iNfO@iNTERLAB.dE, WWW.iNTERLAB.dE

Interlabcentral lab services worldwide