Best Practices in IRT Implementation at a Trial Sponsor Practices in IRT Implementation at a Trial...

Copyright © 2015 Oracle and/or its affiliates. All rights reserved. |

Marc Weinberg, MBA, Consulting Practice Manager, Oracle Health SciencesChris Huang, Director, Product Strategy, Oracle Health Sciences Christy Jacobsen, Manager, Clinical Trial Materials Management, SunovionLeah Patterson, Senior Associate, Clinical Trial Material Management, Sunovion

Best Practices in IRT Implementation at a Trial SponsorWhy Domain Knowledge and Expertise are Critical


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The following is intended to outline our general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, or functionality, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functionality described for Oracle’s products remains at the sole discretion of Oracle.

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Agenda

Study Workflow Challenges

Five Critical Factors to a Successful IRT Study

Why Vendor IRT Experience and Expertise Is Critical

From Vendor to Trusted Partner: The Importance of Relationship

Success Stories: Reducing Time, Cost, and Effort

The Road Ahead: Where We See the IRT Industry Going

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Process Workflow Challenges

• Study Design

– Accelerating design and set up

• Study Initiation

– Deploying studies rapidly

• Data Collection

– Accelerating speed of data collection

• Analyzing Data

– Enabling actionable insights from data

All phases

– Driving down costs

– Ensuring quality

– Increasing efficiency

DesignStudy

Initiate Study

Collect Data AnalyzeData

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Accelerate study design and setup• Enable collaborative versus linear design

process

• Allow nonprogrammers to create complex rules and edit checks

• Provide ready access to existing study objects for easy reuse

• Apply internal or outsourced design best practices

Drive down costs• Free up technical resources for high-

value tasks

• Move repetitive tasks to low-cost roles/regions

• Increase reuse of study designs

Ensure quality• Implement standards with reuse of

validated study designs

• Increase transparency of design process

Key Challenges in Process Workflow: Study Design

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AnalyzeData

Collect Data

Initiate Study

DesignStudy

Study Development Production/Run Time

Key Challenges


Five Critical Factors to a Successful IRT Study

• Customer requirements – Knowing what is needed for success

• Domain expertise, product knowledge, and experience– Being able to operate and guide your customer to success using industry/product knowledge and experience

• Commitment from team members– Finding team member availability within everyday busy schedules

• Open and Clear Communication– More than just an email with questions and requests

• Technology– Product should allow for and encourage a seamless and flawless end-user experience

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Industry Experience and Domain Knowledge are Key

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• Success factors roll-up to experience and expertise

• Expertise helps move lifecycle from one step to the next

– Avoid “hang-ups” that can impact timelines and cost

• Guides final decisions toward “need” and away from “want

– We want everything, but do we actually need it?

• Experience and expertise provide short and long-term benefits to both parties

• Some benefits immediately realized while others come with time and exposure:

– Short-term

• Comfort in driving spec discussion which can be a challenging time for inexperienced team members

• “Translation” from protocol to IRT specification

• Adherence to established build timelines

– Long-term

• Knowing what works and what doesn’t

• Creation of standards/templates (possible reduction in timelines and cost without sacrificing quality)

• Growth of relationship

– What started as more than one now becomes one


From Vendor to Trusted Partner: The Importance of Relationship

• Sunovion and Oracle Health Sciences relationship built on trust, open communication, and service-oriented culture within IRT team and Oracle Health Sciences

• Successful partnership starts from day one

• Sunovion delivered a clear road map to build upon

• Oracle uses domain expertise to deliver high-quality IRT product

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Positive Partnership Built from the Ground-Up

• Preference to meet in-person for key milestones and activities

– Inclusion of relationship-building exercises

• Sunovion comfort and confidence in Oracle ability to successfully lead

– The base of our relationship is comfort and confidence

• Sunovion has developed a strong understanding of what is needed for IRT success

• Oracle-defined customer-specific design model used across multiple trials and programs

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Success Stories

• Ability to accommodate multi-trial programs with protocol unknowns (amendments)

– Many with exact or similar timelines

– Utilization of open communication channels from day one

– Implementation of best practices to successfully build trials simultaneously per established timeline

• In-person meetings versus virtual

– Team members meet in-person for key milestones including kick-off, spec reviews, and UAT

– Ability to hold direct requirement discussions with real-time feedback

• Removes delay of sending and responding to emails

– Beneficial for first-time IRT/Oracle product team members

• Overall continued growth as one team

– Oracle understanding of Sunovion needs for their trials

– Sunovion assurance of Oracle expertise for successful implementation

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The Road Ahead: Where We See the IRT Industry GoingChris HuangDirector, Product StrategyOracle Health Sciences

Oracle Confidential 11

Copyright © 2015 Oracle and/or its affiliates. All rights reserved. | Oracle Confidential 12

The Future of IRT

• Advanced Predictive Analytics and Integrations with Study Build tools

– Manage supply and cost real time

– Big Data integration for inputs

– Expanded drivers for Safety Analytics

• Drug supply forecasting across all protocols for a program and compound

• Auto Configuration from the Protocol and Site Contracts

• Supply Management will be a integral part as patient devices increase

• Drug supply may ship to pharmacies, direct to patient

– Continued expansion of integrations

– Complexity levels will increase

Copyright © 2015 Oracle and/or its affiliates. All rights reserved. | Oracle Confidential 13

The Future of IRT con’t

• Patient Views and Interfaces– Mobile interfaces and patient adherence

– Bi-directional EMR integrations for data updates

• Key part of Post Marketing Studies– Unified drug management from Phase 1 to 4

• Manufacturing and labeling become core modules or integrations

• Regulatory and Inspector interfaces


Summary

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• Industry pressures will only grow, presenting new demands on IRT systems and the people who build and manage them

• IRT will need to become a “proactive” vs. a reactive system

• IRT will need to support more of the regulatory and supply chain e.g. inspections and drug pedigree

• Next-gen IRT systems will need to integrate seamlessly into eClinicalplatforms from planning and initiation to post-marketing

• Regardless of the technology platform, domain knowledge and expertise, effective teamwork, and communication will remain critical components


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Best Practices in IRT Implementation at a Trial Sponsor Practices in IRT Implementation at a Trial...

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