Andrew Ware, UCB
Kevin Shea, C3i
Case Study: Enhancing Sponsor Value through the Extension of Vendor-provided Support Services for OC/RDC
September 2013
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Agenda
» Overview
» Vendor Selection
» Initial Project Parameters
» Communication Channels
» Tracking Vendor Quality
» Add-on Services
» Operational Improvements
» Conclusions
» Questions
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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
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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
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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
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Communication Channels
»Documentation
Call and Escalation Scripts
Knowledge Objects
Metrics
SLAs
Weekly/Monthly Reports
»Meetings
Weekly Status
Quarterly Dashboard
Semi-annual Governance
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Help Desk Handled VolumeActivity Volume
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Tracking volume by category over time identifies trends
Volume per Study
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Study events can drive spikes in volume
Volume per Country
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Monitoring ensures proper coverage of language and business hours
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Assistance Requests - Analysis by Category
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AR Category assessment can identify KO improvement areas and escalation path changes
Assistance Requests - Analysis by Sub-category
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Assistance Requests – Analysis by Sub-Category (p.2)
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Help Desk PerformanceSLA Summary
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SLAs are monitored daily and calculated monthly
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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
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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
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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.
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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
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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
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Questions
Contact Information
Andrew Ware ([email protected]), 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 ([email protected]), 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.