SPOC: The logical choice for supporting your investigative sites
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SPOC: The logical choice for supporting your investigative sites
- 1. OHSUG 2013 – Miami, FL Kevin Shea, C3i SPOC: The logical choice for supporting your investigative sites September 2013
- 2. 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 2 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
- 3. Agenda » Overview » Sites and Clinical Trial Technology » Overview of Help Desk for Investigative Sites » Help Desk Basics » Conclusion » Questions 3 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
- 4. 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 4 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
- 5. 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 5 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
- 6. 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 6 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc. Support for technology required by sites to complete tasks
- 7. 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 7 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
- 8. 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 8 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc. Initial setup most time-consuming – additional support incremental
- 9. 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 9 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
- 10. 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 10 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
- 11. 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 11 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
- 12. 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 12 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
- 13. 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. 13 October 13© 2013 C3i, Inc. Confidential and Proprietary to C3i, Inc.
Notes de l'éditeur
- Most investigative sites that participate in clinical trials are not dedicated to that practice. Typically, an site will have a very small percentage of its patients that participate in trials. The focus of site personnel, from a resource allocation, tats priority, and overall financial focus is not on the protocol but on managing the care of the majority of patients who are not in a trial. As a result, the time that site personnel can dedicate to the technology needed to participate in a trial is extremely limited. Anything that impairs the use of those tools – such as log in issues, unexpected system behavior, or the inability to enter clinical data – severely impacts the overall efficiency of all operations at the clinical site. Because well-run and high-quality sites are increasingly in demand, anything that reflects negatively on a sponsor or its trial can have detrimental effects that extend to future studies. A professionally run Help Desk, that is expertly set up and supported by a global, mule-lingual staff, well-versed in both the technology and the workflow processes in place at sites can alleviate these issues. In particular, a SPOC – or Single Point of Contact – Help Desk substantially eases the confusion and frustration that can arise among site personnel faced with multiple technologies, with separate log in credentials, ineffective system documentation, harried schedules, and confusing protocol instructions. By establishing a SPOC Help Desk to collect and appropriately triage all issues that arise at all investigative sites, sponsors and CROs can remove a primary source of clinical site dissatisfaction, poor data quality, and timeline slippage.Our presentation will outline how to plan, provision, deploy, and operate a SPOC Help Desk for a large, multinational, phase III clinical trial. We will identify the major deliverables associated with such an effort, including: technology review, site assessment, knowledge object creation, help desk training, site user training, rollout, reporting, and change management. We will also discuss how new technologies, new studies, and new user groups can be added to the Help Desk coverage without impacting operation performance or user satisfaction.