OHSUG 2013 – Miami, FL

Kevin Shea, C3i

SPOC: The logical choice for supporting your investigative sites

September 2013

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

Key Points

» Sites are required to utilize a variety of technologies as part of clinical trials

» Help Desks are integral to high quality site performance in clinical trials

» A Single Point of Contact help desk supporting all technologies utilized by your clinical sites provides tactical and strategic advantages:

Efficiently monitor all technical issues at sites

Enhance site satisfaction

Realize economic benefits

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

Agenda

» Overview

» Sites and Clinical Trial Technology

» Overview of Help Desk for Investigative Sites

» Help Desk Basics

» Conclusion

» Questions

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

Overview

» Investigative site users are challenged: Focus on clinical practice

Maintain proficiency on all technologies

Perform clinical trial tasks with efficiency and quality

» Each technology required by investigative site users must be supported

» Help desks agents must be able to: Triage calls from site personnel

Address/Resolve as many issues as possible

Escalate more complex issues

Track all issues

Follow-up with user to ensure resolution

» Trials have become: More complex

More reliant on technology

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

Sites and Clinical Trial Technology

» Sites are required to manage more complex trials and maintain proficiency on an increasing categories of technology solutions

» Typical technology solutions: EDC

IVR

ePRO

Portals

» Global aspect of trials means language and cultural barriers across the participating sites

» More sites participate in multiple trials, for more than one sponsor/CRO

» Multiple vendors used for same purpose: Difficult for site personnel to establish and maintain proficiency

Use of given type of system driven by enrollment, number of studies, etc.

» Attrition/turnover at sites complicates training and knowledge of proper use of technology

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

Help Desk Services for Investigative Sites

» Help Desk (Tier 1) Initial line of contact

Triage the issue

Resolve if possible > Focus is on first-call resolution

Escalate as needed (Tier 2/3)

» Help Desk Agents Establish rapport with user – empathy, patience

Follow-up on escalated issues – consistency

Report back to user

Ensure closure/satisfaction

» Users Different types of users at sites – PIs to Data Entry

Focus is on completing tasks, not learning new systems

Site satisfaction is critical metric

Support for technology required by sites to complete tasks

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

Help Desk Basics

» Help Desk team can be dedicate or shared – volume, economics driven

» Interfaces for user interaction Email

Telephone

Chat

» Call Scripts Consistent Messaging

Accurate escalation

» Knowledge Objects Common knowledge across Help Desk

Up to date information

» Call logging and issue tracking

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

Help Desk Implementation

» Provisioning of interfaces Telephony – per country toll-free numbers

Email – common email address

Chat – distribute client

» Script development IVR

Call

Escalation

» Knowledge Object creation Information development

Coordination with sponsor/CRO and/or vendor

Agent training

» Configuration of call-tracking system

Initial setup most time-consuming – additional support incremental

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

Help Desk Management

»Service Level Agreements Contractual

Phased approach w/ new service

Abandon Rate, CSAT, 1st Call Resolution, Resolution Time, Escalation Rate

»Communications Meetings

Reports

»Subject Matter Expertise Knowledge Object

management

Back-up agents and QA

»Quality Assurance

Sampling

Compliance/Remediation

»Resource Management

Languages

Hours of operation

Training

»Metrics Tracking and Forecasting

Historical data

Trending

Forecast

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

Help Desk Economics

» Implementation phase costs Generally one-time only

Number of countries, number of languages

Largely independent of technology(s) supported

Similar effort for large and small user bases

Management effort is dependent on number of agents required (languages and anticipated call volume)

Templates allow for efficiency

»On-going costs Telephony and related system recurring costs

Agent desk – call volume, languages

Translation

Management

Reporting

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

Help Desk Re-Utilization for New Systems

» Establishment of a Single-Point of Contact Help Desk to handle site-generated issues across technologies

One contact point for site personnel

Consistent language capabilities

Maintenance of agent-site rapport

» Consolidation Agent desk – buffers against per technology volume fluctuations

Reporting – comprehensive - insights into site performance, issues, training

» Financial benefits Lower escalations over time

Single implementation can be extended as new technologies are added

Languages can be added or removed as site roster changes

Solution can be used across multiple trials, indications, phases

» Management Benefits One vendor, one cost model

Governance and control

Strategic partnership

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

Conclusions – SPOC Help Desk Benefits

» Sites are required to utilize a variety of technologies as part of clinical trials

» Help Desks are integral to high quality site performance in clinical trials

» A SPOC Help Desk that supports all technologies utilized by clinical sites provides:

Strategic value

Enhances site satisfaction

Economic benefits

» Logical choice

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

Questions

Contact Information:

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.