Clinical Investigator Portal Innovation and Support Profile

Clinical Investigator Portal Innovation and Support Profile

Tom Staada, Account Director, C3i

Kevin Shea, Senior Director, Clinical Solutions, C3i

Monte Carlo, Monaco November 2012

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Overview

» Clinical Investigator Portals can be an innovative, consistent, and useful entry point for study trial participants to access systems they require to complete their tasks.

» Portals vary in robustness and complexity

» In attempting to determine the correct level of functionality and complexity, we sought to determine the presence of a correlation:

Complexity of a Client Investigator Portal

and

The number and type of Support Requests

Focus of Presentation

» Evaluate several Clinical Investigator Portals

» Assess the associated technology related issues

» Determine if correlations can be drawn

» Propose opinions information collected

» Propose recommendations for best practices

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Definitions

» Presentation makes these assumptions:

» Definition: an Investigator Portal is a Web-based access interface provided to study participants and hosted by CRO or Sponsor

» Qualification of the assessed portal �  Must be classified an investigator portal

�  Must provide access to OC/RDC

» Measurements �  Support Profile compiled using 3 months of data.

�  May – July of 2012

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The Customer and its Oracle Environment

» Evaluated three organizations’ portals that we currently support

�  One CRO

�  Two Sponsors

» All three customers are utilize RDC Onsite

» Data comes from:

�  12000+ Active Sites

�  1100+ Active Studies

�  3000+ Support Tickets over 3 Months

» Profile of Complexity of Investigator Profiles

�  1 – Low Complexity Portal

�  1 – Medium Complexity Portal

�  1 – High Complexity Portal

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Client # 1 – Client Investigator Profile

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»  International CRO

�  30 Active Studies utilizing OC/RDC

�  730 Active Sites

» Features

�  Access to OC RDC

�  OC RDC training

�  Read study related news and documents

�  Links to external study related websites

�  Read study related reports

�  Read study related documents

» Complexity: Low

Client # 1 – Support Profile

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Category Support  Tickets PercentageUser  Admin   125 42.37%Training 102 34.58%Access  to  OC-­‐RDC 23 7.80%Problem/Error 23 7.80%Navigation 22 7.45%Total 295

Client # 2 – Client Investigator Profile

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» Major Pharmaceutical Company �  995 Active Studies using OC-RDC

�  6198 Active Sites

» Main Features

» Complexity: High

Access to OC-RDC

Alerts

View Outstanding Tasks

Trial Events

Enrollment Metrics

Trial Library

Drug Inventory Log

Reports

Financial Data

Supply Ordering

Client # 2 – Support Profile

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Category Support  TicketsPercentageUser  Admin   1076 91.81%Navigation 72 6.14%Problem/Error 22 1.88%Access  to  OC-­‐RDC 2 0.17%Training 0 0.00%Total 1172

Client # 3 – Client Investigator Profile

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» Major Pharmaceutical Company

�  90 Active Studies using OC-RDC

�  5806 Active Sites

» Features

�  Access to OC-RDC

�  Data Entry

�  User Administration

�  CRA Monitoring

�  Protocol Specific Files

�  Patient Enrollment and Randomization System

�  Training Modules

» Complexity: Medium

Client # 3 – Support Profile

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Category Support  Tickets PercentageUser  Admin   1181 81.06%Navigation 128 8.79%Access  to  OC-­‐RDC 99 6.79%Problem/Error 42 2.88%Training 7 0.48%Total 1457

Comparisons

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Category Sppt  Tickets Pct. Sppt  Tickets Pct. Sppt  Tickets Pct. Sppt  Tickets Pct.User  Admin   125 42.37% 1076 91.81% 1181 81.06% 2382 81.46%Navigation 22 7.46% 72 6.14% 128 8.79% 222 7.59%Access  to  OC-­‐RDC 23 7.80% 2 0.17% 99 6.79% 124 4.24%Training 102 34.58% 0 0.00% 7 0.48% 109 3.73%Problem/Error 23 7.80% 22 1.88% 42 2.88% 87 2.98%Total 295 1172 1457 2924

Client  #  1 Client  #  2   Client  #  3 Totals

»  Client # 1 has a higher volume of training related support tickets, as training modules are embedded into support portal

»  Client # 2 and # 3 see a much higher percentage of User Admin, but the other areas remain close in pct of support tickets

Comparisons (cont.)

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Category Metric Metric MetricClient #1 #2 #3Portal  Complexity Low High Medium#  of  Support  Tickets   295 1172 1457#  of  Active  Sites 730 6198 5806Tickets/Sites 0.40 0.19 0.25

» With low complexity of features, Client # 1 has the highest ratio of tickets per site.

�  Self paced training modules generate 35% of tickets

»  Although Client # 2 has the most complexity and feature offerings, it has the lowest amount of tickets per site.

�  User Adoption of Features – unknown?

�  Could be that portal is well organized and supported

�  End User Survey – or Survey Data to back analysis could be helpful

»  Client # 3 falls closer to # 2 in support volume, and complexity

Summary

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»  Clinical Investigator Portals are used for a variety of reasons, including: »  Access Point to OC-RDC

»  Embedding Training Modules

»  Reporting

»  Financial Data

»  Requesting Supplies

»  In our review, user administration issues were the primary driver of help desk tickets across the three portal types

»  Complexity does not appear to drive help desk call volume »  Portal with the Most complexity had the lowest ratio of support issues

»  Portal with the least complexity had the highest ratio of support issues

»  Fuller assessment of differences in training modules should be considered

» Our review did not ascertain if complex portals are used more extensively by portal users. »  End User Surveys could be held to determine what features are favored, and what

features have not had the user adoption

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Presenter’s Bios

»  Tom Staada ([email protected], +1 973-401-4623) is an Account Director at C3i, Inc. At C3i, Tom manages the day-to-day relationship between a large CRO and the C3i Support Desk. He has over 8 years of Operations experience, including 6 years in clinical support operations. Tom has presented at OHSUG for the last 3 years (2009-2011) and is experienced in a wide array of support-related areas, such as forecasting, knowledge base development, call avoidance, and software upgrade. Tom graduated from the University of Delaware where he received his Bachelors of Science in Health and Exercise Science.

»  Kevin Shea ([email protected]), Senior Director, Clinical Solutions, C3i, has been involved in the Pharmaceutical/Life Science industry for 12 years, with an emphasis on clinical technology, clinical data management, clinical operations, and associated business processes. He has account director responsibilities for a number of C3i’s clients and leads C3i’s BPO services offering, which is a set of solutions providing hosting and services for OC/RDC, TMS, and CTMS.