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 April 7, 2023© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.

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

© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.

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 (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.