CDM Capability Slides

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  • 1. Full Service 25 CRO YEARS Accelerating Pharma time-to-market, cost effectively Track RecordClinical data management Asia Europe Americas Clinical data management capability 1
  • 2. Full Service 25 CROOverview of CDM services YEARS Track Record • Project management • Protocol review • CRF design • Database design • CRF tracking • Data entry • Data management plan • Data validation specifications • Discrepancy management • Query generation • Laboratory data management • SAE reconciliation • Electronic data transfer 2
  • 3. Full Service 25 CRO IT Infrastructure YEARS Track Record High quality Service High quality Service Compliance to SOP and Delivery Support Delivery regulation CDM Central Lab Medical Writing Services Pharmacovigilance BA/BE Statistical Analysis Clinone/ OC OC RDC MedDRA WHO DD DMS SAS STARLIMS Application ARK Business Applications are in 3 tier architecture & deployed in test and production environment separately Cisco Routers/ Scalable & High capacity Qualified & Windows Oracle / SQL SANInfrastructure Switches/ Structured B/W internet & Trained OS Database Storage Firewall Network WAN links People Quality & Standards ISO 9001, ISO 27001, CSV, 21 CFR PART 11 Compliance, IT Policies & SOPs 3
  • 4. Full Service 25 CRO CDSM platform deployed by Infosys YEARS Track Record • Oracle 4.5.3 with RDC • TMS 4.6 integrated with WHO-DDE and MedDRA dictionaries • SAS 9.2• Deployed in 3 environments, test, development and production with 3 tier architecture• Database server is on UNIX OS for high availability• Sized to take high volumes• Validated as per CSV lifecycle with IQ, OQ and PQ• System compliant to 21 CFR PART 11 and audited by Lachman Associates• Annotations are done as per CDISC convention/sponsor specific• SOPs in line with GCDMP and ICH GCP standards and recommendations• Stability is time tested with 54 projects handled through current system Mature CDM system with proven performance 4
  • 5. Full Service 25 CRO Data Security Policy & Disaster Recovery Plan 21 CFR Part 11 compliant, security controls follow ISO 27001 standards YEARS Track RecordData Security Policy Disaster Recovery Plan• Secure data center with biometric access control & Enterprise wide disaster recovery plan (SOP) to surveillance camera take care of business continuity in case of natural• IT policies for password management, shared calamities and disasters resources, end-point security BCPs to take care of any circumstance of non• Antivirus, content /URL/spam filtering system, and availability of business critical applications network monitoring systems Replication of database archival logs to different• Perimeter firewall prevents unauthorized access. location for restoring data up to latest transaction High level encryption compatible Backup & restore policies with written RPO and• Data transfer of secure FTP, secure email thru site- RTO to-site VPN/Internet• Role based access for all the applications Mock testing of backup restore procedures on regular basisData Backup Online backup system with tape library Daily incremental backup and weekly full backup Onsite storage of data tapes in fireproof data safe and offsite storage with archival agency 5
  • 6. Full Service 25 CRO Experience and resources YEARS Track RecordFUNCTION EXPERIENCE STAFF IN STAFF IN Σ EUROPE INDIAData management Up to 8 years 1 6 7programmerData manager Up to 15 years 3 12 15Clinical data associate Up to 3 years 5 6 11Database administrator Up to 8 years 2 1 3Biostatistician Up to 28 years 2 8 10Statistical programmer Up to 15 years 4 5 9Medical writer / coder Up to 20 years 2 13 15 Σ 19 51 70 Deep domain experience both in Europe and India 6
  • 7. Full Service 25 CRO CDM Team YEARS Track Record Data managers Database administrator Database programmers Clinical data associates Medical coder Biostatistician / SAS programmer This team is led by highly qualified leaders with deep domain experienceQualified in medicine, pharmacy, biotech or IT & experience in CDM
  • 8. Full Service 25 CROProject management –Communication channel YEARSCan set up project management between Europe, Asia and USA Track Record STAT SITES CRL DM Programmer PDM PM Data Manager Clin Data Assoc Medical CodersSPONSOR QA 8
  • 9. Full Service 25 CRO CDM workflow YEARS Workflow & process built around globally accepted practice Track RecordStudy setup CRF annotation •CDISC compatible• Resource allocation CRF Designing DB design & validation •Sponsor specific• Project plan• Training Data management plan Prg of validation checks DATABASE LIVE BV CRF data Data entry Data validation •Receipt and tracking •Control and storage Paper -CRF • Discrepancy management Non- CRF data Query generation & Medical coding Database lock resolution Quality control Statistical analysis SAE reconciliation 9
  • 10. Full Service 25 CRO RDC Project Execution & Delivery Process (1/2) YEARS Track Record EA Project Management Team Escalation Sponsor EDCCountry Project Manager 1 System; Country Project Manager 2 Other OC RDC Services --------- 4.5.3 ---------- Country Project Manager 9 Database Design Discrepancy Management Quality Control, Database Lock CDM Team Countries RDC Helpdesk Sites Patients 10
  • 11. Full Service 25 CRO RDC Project Execution & Delivery Process (2/2) YEARS Track Record• End-to-end clinical data management activities will be performed by trained and an experienced team. Each functional representative on a team brings a unique set of experiences, skills, and knowledge• Data management activities performed will be compliant to the SOPs. QC process is implemented to verify that processes and procedures have been followed including documentation• The data management system used is OC RDC tool which is stable, 21 CFR PART 11 Compliant and web based application hosted in MAL data center on high capacity servers.• The study database is validated prior to the start of live data entry.• A well defined Data Management Plan is prepared which defines the scope of work, responsibilities, communication plan, description of the various data management activities performed, timelines, Quality and regulatory standards to be met and how they will be achieved, Communication plan , Applicable processes and SOPs including project specific processes and procedures– Prior to database lock, the QC of all the critical data points is performed and a final inspection is performed on all the data points of the sample size subjects. The database is audited for accuracy and completeness• Regular updates is provided to the sponsors at regular intervals in the form of status reports• Communication channel between the sponsor and the CRO will be clearly defined at the beginning of the study 11
  • 12. Full Service 25 CROElectronic data capture system build workflow (including but not limited to) YEARS Track Record 12
  • 13. Full Service Data Entry and Discrepancy Management in in RDC 25 CRO YEARS Track RecordData entered by site staffSystem-generated Discrepancy closed Site staff correct by system, CRA or discrepancies eCRF DM Changes rejected Validation Site staff correct CRA reviews eCRF or comment changes or CRA performs SDV Checks on entered data comments Investigator approves eCRF CRA verifies eCRF Casebook 13
  • 14. Full Service 25 CRORDC Work Flow Diagram (for a complete study) YEARS Track Record FPI LPOProtocolReview CRF DB Design Edit Checks RDC Training for DB Maintenance DB Review & Validation programming Site Personnel Closure External Data Definition Discrepancy Management Site Provisioning 14
  • 15. Full Service 25 CRO Performance - Quality measures YEARS Track Record DB lock checklist Clinical DB lock study report 100% check Quality control is applied to each stage of Statistical of numbers, data handling driven by SOP to ensure that analysis: check of all data are reliable and have been Double pro- statements processed and reported correctly. gramming, Blind table check data QA- CRF to review Programmed & database manual checks, inspection clean and Double dirty dummies Finalize DB CRF data entry structure on trackingSystem full dummyvalidation extractby CSVteam GCDMP, ICH GCP & FDA 21CFR Part 11 followed in the process 15
  • 16. Full Service 25 CRO CDM experience- India since 2005 Wide therapeutic experience and consistent growth YEARS Track Record Oncology, 9, Respiratory, 13, 15% 21% NSAID, 1, 2% Neurology, 3, 4% Musculoskeletal, Nutrition, 1, 2% 3, 5% Gastroenterolog Ophthalmology, y, 4, 7% 7, 11% Endocrinology, 5, 8% N = 61 Dermatology, 3, Cardiology, 12, 5% 20%Year 2005 2006 2007 2008 2009 2010 2011No. of Studies 3 13 9 8 16 5 7No. of CRF pages 107 6589 57642 65214 31230 73003 24346handled 16
  • 17. Full Service 25 CRO Flexible service delivery models YEARS Track Record India EU Experience, India advantage 40No. of trials 30 PM in PM in PM in 38 Frankfurt Bangalore Frankfurt 20 23 Conduct Conduct in Conduct in 10 in FFM BLR BLR & FFM 0 Standalone End to end Europe Deliver quality data speedily at competitive cost & personalized service
  • 18. Full Service 25 CROContact us www.ecronacunova.com YEARS Track RecordWe accelerate Pharma time-to-market cost effectively ASIA EUROPE AMERICASSJR I Park, Mobius Hahnstrasse 70 502 Carnegie CenterEPIP, Whitefield D-60528 Suite # 100 PrincetonBangalore – 560 066 Frankfurt NJ 08540,India Germany USAbdasia@ecronacunova.com bdeurope@ecronacunova.com bdamericas@ecronacunova.com+91 80 6691 5787 +49 69 6680300 +1 973 396 2742 Thank You 18