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Case Study: Enhancing Sponsor Value through the Extension of Vendor-provided Support Services for OC/RDC

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Kevin Shea
Kevin Shea

This case study examines how a pharmaceutical sponsor enhanced value from a vendor-provided clinical trial support service by expanding the services over time. The initial services focused on technical site support and help desk functions. Tracking service quality metrics allowed the identification of areas for improved knowledge bases and processes. Based on the initial success, the sponsor worked with the vendor to take over additional tasks like training and account management, freeing internal resources for more strategic work. Close communication and a commitment to continuous improvement were keys to success.

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Andrew Ware, UCB Kevin Shea, C3i Case Study: Enhancing Sponsor Value through the Extension of Vendor-provided Support Services for OC/RDC September 2013
Agenda » Overview » Vendor Selection » Initial Project Parameters » Communication Channels » Tracking Vendor Quality » Add-on Services » Operational Improvements » Conclusions » Questions 2 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
Overview This case study: »Examines the key drivers for vendor selection »Describes the initial set of services »Discusses how a limited set of support services provided initial value and triggered the extension of services »Examines how service delivery quality was tracked and managed »Describes a key end result – freeing the sponsor’s team to focus on complex and strategic tasks 3 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
Client’s Vendor Selection Process »Established in business sector »Existing client base »Size »Global extent, 24x7x365 »Multi-lingual »Technology platform supporting operations »Familiarization with clinical, GCP, etc. »Experience supporting clinical investigative sites »Capabilities in supported technology 4 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
Project Start-up and Initial Services »Implementation started in June 2009 »One study with five sites »Completed in two months Configure call tracking system Establish Knowledge Objects (KOs) Build call scripts and escalation paths Train agents Establish per country telephony »Initial focus on support services: Technical Site Assessment OCRDC 4.5.3 site support 5 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
Communication Channels »Documentation Call and Escalation Scripts Knowledge Objects Metrics SLAs Weekly/Monthly Reports »Meetings Weekly Status Quarterly Dashboard Semi-annual Governance 6 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
77 October 2, 2013 Help Desk Handled Volume Activity Volume © 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc. Tracking volume by category over time identifies trends
Volume per Study 8 October 2, 2013© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc. Study events can drive spikes in volume
Volume per Country 9 October 2, 2013© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc. Monitoring ensures proper coverage of language and business hours
1010 October 2, 2013 Assistance Requests - Analysis by Category © 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc. AR Category assessment can identify KO improvement areas and escalation path changes
Assistance Requests - Analysis by Sub-category 11 October 2, 2013© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
Assistance Requests – Analysis by Sub-Category (p.2) 12 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
1313 October 2, 2013 Help Desk Performance SLA Summary © 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc. SLAs are monitored daily and calculated monthly
Tracking Vendor Quality »Vendor-provided standard reports Derived from call-tracking system Documented SLA performance »Reports allowed client and vendor a common source to identify issues »Client was able to initiate customization to reports to facilitate visibility to specific service areas »Customer-satisfaction surveys of clinical site personnel »Client-generated user surveys 14 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
Extension into New Services » End User RDC Training – e-learning training for five different roles created and Hosted by Vendor » Multiple languages added European Languages - 5 with live agent and another 14 with live agent/Translation service Asian Languages– Japanese, Korean, and Mandarin » RDC account request processing » User Administration » ISP and HW Provisioning » Image Engineering – laptop image creation and application 15 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
Operational Improvements Service Areas Description UA Turnaround Time Optimized the operation to allow 24-hour or less Reporting More flexible reporting tool – allows YTD review and easier configuration UA Reviewer Accounts Took ownership of the Reviewer account cases – previously Client Tier 2 task CTA Escalation Reports Implemented report to reduce the time to follow up on individual cases UA Data Management Accts Decreased the turnaround time for DM accounts via new report implemented for Tier 2 needs Automated Call- Tracker Follow-up Replaced manual workflow with automated follow up notifications – reduce time for end user feedback eLearning Updates Performed several Updates on the ELearning Modules and Assessments. 16 October 13© 2013C3i, Inc. Confidential and Proprietary to C3i, Inc.
Conclusions I Global, multi-lingual help desk can add significant value to clinical operations and data management by improving data quality, timeliness, and site satisfaction. Key factors in successfully engaging, implementing, and improving the help desk are: 1. The client should plan, analyze, and establish a robust vendor selection process 2. The vendor should establish early management oversight, initiate project management, and develop analyst training as early as possible 17 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
Conclusions II Client and Vendor should collaborate and work toward: 1. Clear and comprehensive contractual framework 2. Transparent Quality Control / Compliance 3. Multi-level Communications 4. Engage in a Team-approach, with a focus on shared success 5. Actively participate in continual process/service improvements 18 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
Questions Contact Information Andrew Ware (andrew.ware@ucb.com), Assoc. Dir, Data Management, UCB Andy has over 18 years of experience in the CRO/pharmaceutical industry and has been with UCB for 11 years in a variety of roles within the Clinical Data Management group. Recent years have seen him focus on RDC including chairing a cross-departmental task force charged with broadening the use of RDC within the company. Currently he oversees all aspects of the data management for one of UCB's major clinical development programs. His other duties include maintenance of departmental resourcing models and management of several aspects of the departmental budget. Kevin Shea (kshea@c3i-inc.com), Senior Director, Clinical Solutions, C3i. Kevin has been involved in the Pharmaceutical/Life Science industry for 13 years, with an emphasis on clinical technology, clinical data management, clinical operations, and associated business processes. He has Account Director responsibilities for multinational Help Desk clients and leads C3i’s Business Process Services offering, which is a set of Business Process and Application SaaS solutions in CDMS, EDC, Terminology Management, Safety, and CTMS. 19 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.

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Case Study: Enhancing Sponsor Value through the Extension of Vendor-provided Support Services for OC/RDC

  • 1. Andrew Ware, UCB Kevin Shea, C3i Case Study: Enhancing Sponsor Value through the Extension of Vendor-provided Support Services for OC/RDC September 2013
  • 2. Agenda » Overview » Vendor Selection » Initial Project Parameters » Communication Channels » Tracking Vendor Quality » Add-on Services » Operational Improvements » Conclusions » Questions 2 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
  • 3. Overview This case study: »Examines the key drivers for vendor selection »Describes the initial set of services »Discusses how a limited set of support services provided initial value and triggered the extension of services »Examines how service delivery quality was tracked and managed »Describes a key end result – freeing the sponsor’s team to focus on complex and strategic tasks 3 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
  • 4. Client’s Vendor Selection Process »Established in business sector »Existing client base »Size »Global extent, 24x7x365 »Multi-lingual »Technology platform supporting operations »Familiarization with clinical, GCP, etc. »Experience supporting clinical investigative sites »Capabilities in supported technology 4 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
  • 5. Project Start-up and Initial Services »Implementation started in June 2009 »One study with five sites »Completed in two months Configure call tracking system Establish Knowledge Objects (KOs) Build call scripts and escalation paths Train agents Establish per country telephony »Initial focus on support services: Technical Site Assessment OCRDC 4.5.3 site support 5 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
  • 6. Communication Channels »Documentation Call and Escalation Scripts Knowledge Objects Metrics SLAs Weekly/Monthly Reports »Meetings Weekly Status Quarterly Dashboard Semi-annual Governance 6 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
  • 7. 77 October 2, 2013 Help Desk Handled Volume Activity Volume © 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc. Tracking volume by category over time identifies trends
  • 8. Volume per Study 8 October 2, 2013© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc. Study events can drive spikes in volume
  • 9. Volume per Country 9 October 2, 2013© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc. Monitoring ensures proper coverage of language and business hours
  • 10. 1010 October 2, 2013 Assistance Requests - Analysis by Category © 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc. AR Category assessment can identify KO improvement areas and escalation path changes
  • 11. Assistance Requests - Analysis by Sub-category 11 October 2, 2013© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
  • 12. Assistance Requests – Analysis by Sub-Category (p.2) 12 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
  • 13. 1313 October 2, 2013 Help Desk Performance SLA Summary © 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc. SLAs are monitored daily and calculated monthly
  • 14. Tracking Vendor Quality »Vendor-provided standard reports Derived from call-tracking system Documented SLA performance »Reports allowed client and vendor a common source to identify issues »Client was able to initiate customization to reports to facilitate visibility to specific service areas »Customer-satisfaction surveys of clinical site personnel »Client-generated user surveys 14 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
  • 15. Extension into New Services » End User RDC Training – e-learning training for five different roles created and Hosted by Vendor » Multiple languages added European Languages - 5 with live agent and another 14 with live agent/Translation service Asian Languages– Japanese, Korean, and Mandarin » RDC account request processing » User Administration » ISP and HW Provisioning » Image Engineering – laptop image creation and application 15 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
  • 16. Operational Improvements Service Areas Description UA Turnaround Time Optimized the operation to allow 24-hour or less Reporting More flexible reporting tool – allows YTD review and easier configuration UA Reviewer Accounts Took ownership of the Reviewer account cases – previously Client Tier 2 task CTA Escalation Reports Implemented report to reduce the time to follow up on individual cases UA Data Management Accts Decreased the turnaround time for DM accounts via new report implemented for Tier 2 needs Automated Call- Tracker Follow-up Replaced manual workflow with automated follow up notifications – reduce time for end user feedback eLearning Updates Performed several Updates on the ELearning Modules and Assessments. 16 October 13© 2013C3i, Inc. Confidential and Proprietary to C3i, Inc.
  • 17. Conclusions I Global, multi-lingual help desk can add significant value to clinical operations and data management by improving data quality, timeliness, and site satisfaction. Key factors in successfully engaging, implementing, and improving the help desk are: 1. The client should plan, analyze, and establish a robust vendor selection process 2. The vendor should establish early management oversight, initiate project management, and develop analyst training as early as possible 17 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
  • 18. Conclusions II Client and Vendor should collaborate and work toward: 1. Clear and comprehensive contractual framework 2. Transparent Quality Control / Compliance 3. Multi-level Communications 4. Engage in a Team-approach, with a focus on shared success 5. Actively participate in continual process/service improvements 18 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
  • 19. Questions Contact Information Andrew Ware (andrew.ware@ucb.com), Assoc. Dir, Data Management, UCB Andy has over 18 years of experience in the CRO/pharmaceutical industry and has been with UCB for 11 years in a variety of roles within the Clinical Data Management group. Recent years have seen him focus on RDC including chairing a cross-departmental task force charged with broadening the use of RDC within the company. Currently he oversees all aspects of the data management for one of UCB's major clinical development programs. His other duties include maintenance of departmental resourcing models and management of several aspects of the departmental budget. Kevin Shea (kshea@c3i-inc.com), Senior Director, Clinical Solutions, C3i. Kevin has been involved in the Pharmaceutical/Life Science industry for 13 years, with an emphasis on clinical technology, clinical data management, clinical operations, and associated business processes. He has Account Director responsibilities for multinational Help Desk clients and leads C3i’s Business Process Services offering, which is a set of Business Process and Application SaaS solutions in CDMS, EDC, Terminology Management, Safety, and CTMS. 19 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.