Rising to Excellence – How a China CRO Rising to Excellence How a China CRO Achieves International Standards Helen Yin, VP & GM Helen Yin, VP & GM Tigermed Tigermed- -MacroStat MacroStat Minzhi Liu, GM, MacroStat Minzhi Liu, GM, MacroStat th 2012 July 7 th July 7 th th , 2012 July 7 July 7 , 2012 2012 1
Outline Outline • Selecting excellent staff • Training staff to consistently meet customer requirements for quality and on time delivery requirements for quality and on-time delivery • Retaining staff in a hot labor market • Rapidly growing business while improving Rapidly growing business while improving customer satisfaction • Handling quick-turn projects 2
Selecting Excellent Staff Selecting Excellent Staff • Build relationships with universities. Identify top students for internships • • Sponsor education programs and events to Sponsor education programs and events to link universities with industry needs • Select only top 20% external recruiters y p • Screen and interview with written tests for technical, computer, communication and language skills language skills. Differentiate: Differentiate: • Entry level • Mid level • Managers and higher 3
Customized and Specialized Training Customized and Specialized Training • SOP and WPD • Industry standards and regulation training Industry standards and regulation training • Project training and experience sharing • Technical English • Technical seminars from local universities and subject matter experts • Internal journal and book club • Internal journal and book club • Shanghai and Beijing Biostat Forum, SAS Users Group, CDISC 4
Building the China Team Building the China Team • Identify candidates Id tif did t – With strong work ethic – Eager to learn and quick to learn Eager to learn and quick to learn • Challenges – Finding candidates with global experience and local – Finding candidates with global experience and local know-how – Different values and culture – High employee turnover rate • Achieve international standards by enforcing process and leadership 5
Retaining the China Team Retaining the China Team • Maintain backlog of projects • Competitive salary and benefits y • Support high-performers obtain further education • Short-term training at clients’ overseas sites • Performance driven evaluation system • Attractive training programs for career development 6
Expand Rapidly While Improving Quality Expand Rapidly While Improving Quality • Go extra mile to satisfy clients – Assign staff with high sense of urgency to quick turn g g g y q projects – Rapidly grow staff to meet urgent needs – Use Tigermed resources for back-up – Tightly watch and control quality for urgent studies • Clinical trial knowledge reinforces the quality of work • Flexibility for non-standard work 7
Continuously Improving Quality Continuously Improving Quality • Always follow SOP and Good Practice guidelines Always follow SOP and Good Practice guidelines. Check and audit. • Programming QC g g – Always double programming and peer review – Compare original and validation results. Complete WPD form for consistency check – QC documentation details in WPD forms – Review logs, run logcheck macro to ensure clean log Review logs run logcheck macro to ensure clean log – Sign PQRT – Quality control gate: Time sequence (e.g., TFL after ADS), Quality control gate: Time sequence (e.g., TFL after ADS), QC documents completed and signed 8
Continuously Improving Quality Continuously Improving Quality • Documentation QC – QC SAR (report) against SAP. Complete company WPD WPD. Review Comment Log R i C t L – QC ReadMe document versus SAP • External QC External QC • Follow clients’ QC process • “Trust but verify” 9
MacroStat as a Case Study MacroStat as a Case Study • Process driven • Align staff’s motivation to achieve business goals. Cascade goals through managers down to each Cascade goals through managers down to each employee. • Effectively evaluate each employee at least semi- annually ll • Communicate clear job expectations and promotion guidelines • Effective leadership by role models • After over 6 years of operation, MacroStat is the largest and strongest CRO in China and strongest CRO in China 10
Protocol Protocol Protocol Protocol Statistics Process Statistics Process SAP SAP Sign Quality Control Gate Sign Quality Control Gate Document Review Document Review (WPD- (WPD -ST ST- -Form) Form) (WPD- (WPD -ST ST- -Form) Form) Sign SAP/Delivery Sign SAP/Delivery Sign SAP/Delivery Sign SAP/Delivery Log Log Sign Sign (WPD (WPD- -ST ST- -Form ) Form ) SAR/CSR SAR/CSR Double Programming Double Programming /Delivery Log /Delivery Log Document Review Document Review Validation Validation (WPD (WPD- -ST ST- -Form) Form) (WPD- (WPD -ST ST- -Form) Form) Peer Review Peer Review (WPD- (WPD -ST ST-Form ) Form ) SAR/CSR SAR/CSR Outputs Outputs Document Review Document Review (WPD (WPD- -ST ST- -Form ) Form ) Sign PQRT Sign PQRT (WPD (WPD- -ST ST- -Form) Form) 11
CDISC Work Process CDISC Work Process Raw data CRF TFL creation and QC CSR a CRF mapping Legacy transfer SDTM spec SDTM spec Yes Yes On going On-going TFL TFL creation ti (Peer review) Study? (Double Programming) SDTM creation ADaM creation ADaM spec (Double Programming) (Double Programming) (Peer review) 12
D D Data Management Process Data Management Process M M P P CRF DB lock Clinical database Final DB QC Q 1 st key entry 2 nd key entry 2 nd key entry 1 key entry Comparison Clean data Clean data Coding/SAE Data Entry complete reconciliation Data Validation (Electronic/Manual Issue query and DCF data review) resolution Central lab data reconciliation 13
DM Process (EDC) DM Process (EDC) DM Process (EDC) DM Process (EDC) Batch validation Batch validation Manually created Manually created EDC EDC Database Queries generated CRA INV Data Close Unreviewed DM EDC system Entry review review queries (SC) review set up Technical Study CRA Investigator DM person Coordinator Ongoing Data Validation Coding, SAE/Lab technical (Clinical/Listing review) (Clinical/Listing review) reconciliation reconciliation support 14
DM Document Development Process DM Document Development Process Not Pass Internal DVP CRF Final Modification review /DMP /DMP Pass Annotated CRF Not Pass External /Variable List review Pass DVP/DMP Final Database setup setup Edit check programming Not Pass Not Pass Programming g g Edit check DB DB DB testing testing modification modification Pass Pass Edit check Edit h k Database production production 15
St Standard Operating Procedures (I) Standard Operating Procedures (I) St d d d O d O ti ti P P d d (I) (I) SOP No. Titles SOP-GA-01 SOP of SOP SOP-GA-02 Deviations to SOPs SOP-GA-03 Protecting Patient Privacy SOP-GA-04 Physical Access Control SOP-GA-05 Electronic Data Transfer SOP-GA-06 SOP GA 06 Documentation and Archiving Documentation and Archiving SOP-GA-07 Final Deliverables SOP-IT-01 Security Of System SOP-IT-02 SOP IT 02 U User And Computer Setup A d C S SOP-IT-03 IT Helpdesk Request Process SOP-IT-04 Information Technology System Maintenance SOP-IT-05 Data backup and Restoration SOP-IT-06 Disaster Recovery Plan 16
Standard Operating Procedures (II) Standard Operating Procedures (II) SOP No. Titles SOP-IT-07 Computer System Validation SOP-IT-08 Validation Plan SOP IT 09 SOP-IT-09 Design Qualification Design Qualification SOP-IT-10 Installation Qualification SOP-IT-11 Change Control SOP-DM-01 DM Project Management SOP-DM-02 CRF Design SOP-DM-03 CRF Printing SOP-DM-04 Database Setup SOP-DM-05 Testing of Data Entry Interface SOP-DM-06 Data Management Plan SOP-DM-07 Data Validation Plan SOP-DM-08 Testing of Electronic Edit Checks 17
Standard Operating Procedures (III) S Standard Operating Procedures (III) S d d d O d O i i P P d d (III) (III) SOP No. Titles SOP-DM-09 CRF Receipt and Tracking SOP-DM-10 Data Entry and Comparison SOP-DM-11 Data Review and Data Editing SOP-DM-12 Query Generation, Tracking, and Resolution SOP-DM-13 Medical Coding SOP-DM-14 SAE Reconciliation SOP-DM-15 External Central Lab Data Handling SOP-DM-16 Database Quality Control SOP-DM-17 SOP DM 17 Database Locking and Unlocking Database Locking and Unlocking SOP-DM-18 DM Trial Master File SOP-DM-19 Local Lab Data Handling SOP-DM-20 Data Extraction from DM System SOP-ST-01 Statistical Project Management 18
S S Standard Operating Procedures (IV) Standard Operating Procedures (IV) d d d O d O i i P P d d (IV) (IV) SOP No. Titles SOP-ST-02 Statistical Analysis Plan (SAP) SOP-ST-03 Biostatistical Analytical Data Checks SOP-ST-04 Generation of Analytical Database y SOP-ST-05 SAS Programming SOP-ST-06 Quality Control SOP-ST-07 SOP-ST-07 Sample Size Calculation Sample Size Calculation SOP-ST-08 Randomization and Unblinding SOP-ST-09 Interim Analysis SOP-ST-10 SOP ST 10 A Analysis Not Prospectively Planned l i N t P ti l Pl d SOP-ST-11 Clinical Study Report SOP-ST-12 DMC Analysis y SOPQ-04 Quality Assurance SOPA-12 Translation Procedure 19
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