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Biometrics Services From BIOMETRICS SERVICES DELIVER UNBLINDED DATASETS TO IDMC SDTM-IG UNBLINDING ADVISORY PLATINUM MEMBER QUALITY ON TIME DATA SECURE BOARDCDISC REGISTERED DEDICATED EMERGENCY SOLUTION PROVIDER EUDRAVIGILANCE PARTNERSHIPTEAM DATA OFFICE UNBLINDING CLINICAL INVESTINGEXPERTISE SHARING STEERING INDEPENDENT TEAM DEFINE.XML CONSULTANCY KNOWLEDGE COMMITTEE SECURE MEDICAL MONITORING STUDY SCALABILITY DATA FLOW SECURED ENVIRONMENT REPORT FLEXIBILITY COMMUNICATION PROGRAM ACCESS RANDOMIZATION SAFETY DATABASE TRAINING PK INPUT RIGHTS ADaM SAFETY FILES TRAINER DRUG SAFETY AND ELECTRONIC DATA MEDICAL WRITING CAPTURE UAT SAFETY PHARMACO VIGILANCE SDTM COMPLIANT DATA SAFETY SUSAR EPRO REPORTS ECOA DATA TA-EXPERTISE ANALYSIS PLAN PROTOCOL eSOURCE SDTM ORACLE MANAGEMENT 100% INFORMTM EDC USER LIBRARIES ONGOING REVIEW - MANAGEMENT SAE RECONCILIATION QC ® MERGE EPIDEMIOLOGY VE eCLINICALOS™ EFFICACY AND SAFETY SUMMARIES CDASH TOXICOKINETICS ADAPTIVE TRIAL ARANCY CODING RA POOLING DESIGN PROCEDURES PK/PD STATISTICAL ANDARDS ATA ATA ADaM ANALYSIS TRANSP NON ANALYSIS PLAN D ST COMPARTMENTAL PK ANALYSIS ADAPTIVE MEDID PK/PD TLFs TRIAL TLFs DESIGN ADaM COMPLIANT TISTICS TA PROTOCOL AND CSR REVIEW BIOS CLINICAL RESEARCH SOLUTIONS SGS Life Science Services is a leading contract service organization providing clinical research, analytical develop- ment, biologics characterization, biosafety, and quality control testing. Delivering solutions for bio-pharmaceutical companies, SGS provides full Phase I-IV clinical trial management services encompassing clinical project man- agement and monitoring, biometrics, medical monitoring, pharmacovigilance and regulatory consultancy. We are committed to our sponsors’ satisfaction and we will leverage the full strength of our more than 1,600 employee organization and global experience to make your projects a success. BIOMETRICS SCOPE OF SERVICES SGS Life Science Services biometrics data management, secure data office, be provided within full project service group is a European leader in Biometrics biostatistics, PK/PD analysis, clinical outsourcing but can also be provided as with over 35 years experience. SGS of- study report (CSR) development, as well standalone services. fers full biometrics services encompass- as pharmacovigilance and drug safety ing protocol development, (e)CRF design, services. Each of these services can COMPLETE BIOMETRIC SERVICES THROUGH THE CLINICAL DEVELOPMENT PROCESS PROTOCOL (e)CRF DATA PK / PD CLINICAL DEVELOPMENT DESIGN MANAGEMENT BIOSTATISTICS ANALYSIS REPORT CDISC – CDASH CDISC – SDTM CDISC – ADAM ICH – E3 RANDOMIZATION AND UNBLINDED SUPPORT BY SECURE DATA OFFICE PHARMACOVIGILANCE AND DRUG SAFETY All SGS biometrics services are per- During the last 10 years we delivered pages per year, allowing for economies formed in accordance with international optimized functional services for over of scale. regulatory standards, Food & Drug Ad- 800 trials, for small, medium and large ministration (FDA), European Medicines pharma companies, ranging from phase Agency (EMA), and ICH- GCP. I to IV and processed over 1 million CRF CDISC REGISTERED SOLUTION PROVIDER SGS has used the SDTM structure for In December 2010, SGS succeeded ■ Developed our own implementation many years, and all trials are processed in obtaining qualification as an official guide for SDTM using CDISC standards. This complete CDISC Registered Solution Provider for ■ Implemented CDISC ADaM in the CDISC compliance results in efficiency, the following standards: Pharmacokinetics department time saving, process improvement, ■ Advised multiple sponsors on reduced time for regulatory submissions, ■ Submission Data Tabulation Model CDISC implementation guides for and better communication among team (SDTM) SDTM and ADaM members without delays in reporting ■ Analysis Data Model (ADaM) ■ Successfully supported multiple final data. ■ Define.xml FDA submissions ■ Become a member of the CDISC Since then, we have continued to Advisory Board progress and strengthen our CDISC ■ Devoted a registered European experience. We have: ADaM trainer for CDISC in the Biostatistics team ■ Reached CDISC Platinum ■ Trained employees on Standard for membership the Exchange of Nonclinical Data (SEND) CLIENT DEDICATED BIOMETRICS PROJECT MANAGEMENT On a project level, cross functional or sponsor to facilitate the communi- operate under the umbrella of a single teams are managed by a dedicated SGS cation and assure consistency across business unit. Biometrics Project Manager who is different trials. To gain efficiencies, our allocated to a specific project, compound biometrics and pharmacovigilance team MUN COM ICATION ION IZAT PEO AN PL RG E M O A SPONSOR N AG G E IN M V EN L T O S - M E L PROJECT A B C O C R MANAGER U P R A BIOMETRICS C MEDICAL Y PHARMACOVIGILANCE Y WRITING T I L A I F L T EDC TEAM PK/PD ANALYSIS E N X E I B D I I F L I N T O DATA Y C SECURE DATA OFFICE BIOSTATISTICS MANAGEMENT QUALITY AND CLIENT ORIENTED ACCREDITED PROJECT MANAGERS With such a comprehensive and experi- with the line managers, is able to antici- services from full package projects to enced Biometrics group, SGS is capable pate upcoming resource needs when- stand alone activities, providing full end- of working on a large volume of trials ever the workload of a project increases to-end project solutions with integrated while still remaining very flexible. The or timelines shift. With this approach project teams. Biometrics Project Manager, together SGS can handle every client request for SGS KEY ADVANTAGES AS LEADER IN BIOMETRIC ACTIVITIES FLEXIBILITY, REACH & • Customized sponsor approach for each project SCALABILITY • Biometrics support for projects across all regions of the world • A core team organized for flexible allocation and easy scale-up of resources • Over 35 years experience SUSTAINABILITY • Continuous investment: infrastructure, operations, and talent recruitment • Robust and standardized processes proven consistency over a decade • CDISC registred solution provider for SDTM, ADaM and define.xml EXPERTISE • Dedicated teams with expertise across a wide range of therapeutic areas • Official partner of the major EDC providers (Oracle, Medidata, Merge) SGS MEANS • Shorter data processing & reporting timelines due to use of CDISC standards QUALITY & ON TIME • Tools allowing reuse of validated database structures, rules and macros DELIVERY • Ongoing review and monitoring of patients safety (eg; for IDMC/DSMBs) ELECTRONIC DATA CAPTURE Our Data Management team has signifi- cant experience managing EDC trials for all types of early and late phase projects. We began building our EDC experience in 2002 in collaboration with several EDC providers. TAILORED eCRF DESIGN IN INFORMTM, RAVE®, AND eCLINICAL OSTM The SGS project team guides the spon- phases and therapeutic areas allow us to sor in making the best choice to fit trial efficiently translate your specific clinical and program specific needs. Years of data requirements into a well designed experience in building trials across all trial eCRF. … WITHIN CHALLENGING TIMELINES With the efficiency that comes with including additional study features such experience, our highly skilled EDC team as IWRS/IVRS integration and validate members can set up your EDC trial these in a limited time frame thanks within 6-10 weeks while still delivering to the large pool of experienced UAT- a high quality end product. SGS is able testers. The timelines are even sharper to design EDC applications from scratch when starting from library eCRF screens. AVERAGE STUDY START UP TIMELINES GO-LIVE EDC DRAFT STABLE DRAFT eCRF & FINAL + PROTOCOL PROTOCOL START CLEANING ACTIVITIES eCRF EDIT CHECKS AND UAT 10 DAYS 30 DAYS >15 DAYS CRF ANNOTATION AND DATABASE SET-UP 1ST SDTM DATASETS DELIVERED TO SPONSOR ELECTRONIC PATIENT DIARIES AND QUESTIONNAIRES (eCOA/ePRO) Today, collection of information reported SGS partners with leading industry’s at home using their own devices, by the patient himself through electronic eCOA vendors to provide you with the including smartphones, tablets and patient reported outcomes (ePROs), also right eCOA solution for your clinical trial. computers/laptops. referred to as electronic clinical outcome Based on the client’s preferences, we assessments (eCOAs), has become in- can offer device-based solutions for both creasingly important for drug efficacy and home and site use, or we can offer a safety information, quality of life device independent approach, enabling assessment and compliance monitoring. patients to complete the questionnaires INTEGRATING EDC TRIALS TO BECOME eCLINICAL SOLUTIONS EDC applications are not necessar- Our team takes the lead in: ■ Designing electronic Serious ily stand-alone systems. To efficiently Adverse Events forms for standard- manage patient randomization, drug ■ Writing the integration requirements ized documentation of the adverse dispensation, study blinding, local lab ■ Defining a solution for all technical events in collaboration with our data, follow-up on (Serious) adverse challenges to enable a seamless Pharmacovigilance department event reporting etc., the EDC application implementation might require one-way or even two-way ■ Setting up cost-efficient integrated data integrations with other electronic IWRS solutions in collaboration with applications. secure data office eCRF DESIGN & LIBRARY MANAGEMENT RANDOMIZATION & DRUG SUPPLY MANAGEMENT ORACLE INFORMTM + IRT ELECTRONIC SAE FORM eCOA/ePRO SOLUTIONS MERGE eCLINICALOSTM USER ACCEPTANCE TESTING LAB NORMAL RANGE MANAGEMENT MEDIDATA RAVE®
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