Slide 1: Practical Strategies for Taking on New Studies Post COVID-19
Practical Strategies for Taking on New Studies Post COVID-19
Slide 2: Table of Contents
Table of Contents 1 Introductions 2 Ensuring readiness when opening your doors 3 Establishing your competitive advantage 4 Tips for working with sponsors and CROs 5 Best practices for deciding which studies to accept 6 The future of study feasibility and how to expedite Copyright © Veeva Systems 202
Slide 3: Speakers
Speakers Melissa Holbrook MSN, NP Mindy Muenich Bree Burks, MSN, RN Vice President, Operations Senior Director VP Strategy, Site Solutions Velocity Clinical Research Huron Consulting Group Veeva Systems Copyright © Veeva Systems 2020. Veeva Confidential. 3
Slide 4: Polling Question 1 of 3
Polling Question 1 of 3 Copyright © Veeva Systems 2020. Veeva Confidential. 4
Slide 5: Polling Question 2 of 3
Polling Question 2 of 3 Copyright © Veeva Systems 2020. Veeva Confidential. 5
Slide 6: Polling Question 3 of 3
Polling Question 3 of 3 Copyright © Veeva Systems 2020. Veeva Confidential. 6
Slide 7: What should sites consider to ensure readiness when opening their doors?
What should sites consider to ensure readiness when opening their doors? Copyright © Veeva Systems 2020. Veeva Confidential. 7
Slide 8: What should sites consider to ensure readiness when opening their doors?
What should sites consider to ensure readiness when opening their doors? Consider the safety for staff, participants and monitors: • Staff: − Some sites had to reduce staff: do you have the staff to restart? − Do you have PPE in order to protect the staff from potential exposure? − Are you screening
Slide 9: What should sites consider to ensure readiness when opening their doors?
What should sites consider to ensure readiness when opening their doors? • Communicate and share with your sponsors and CROs how you are preparing for their safety: • Do you have monitoring space that is outside of a patient care area? • Are you able to manage remote monitoring visits? • Have you be
Slide 10: How can sites establish their competitive advantage?
How can sites establish their competitive advantage? Copyright © Veeva Systems 2020. Veeva Confidential. 10
Slide 11: Establishing your competitive advantage
Establishing your competitive advantage 1 2 3 4 Establish your Gather information Confirm your Bring your own credibility from sponsor/CRO resources and ability data to the table to run study Copyright © Veeva Systems 2020. Veeva Confidential. 11
Slide 12: Establishing your competitive advantage
Establishing your competitive advantage 1 2 3 4 Establish your Gather information Confirm your Bring your own data credibility from sponsor/CRO resources and ability to the table Establish a baseline • Project nuances, timelines, • PI availability, and • What does the sponsor/CRO understanding of wh
Slide 13: What are some best practices for determining which studies to accept?
What are some best practices for determining which studies to accept? Copyright © Veeva Systems 2020. Veeva Confidential. 13
Slide 14: What are some best practices for determining which studies to accept?
What are some best practices for determining which studies to accept? Feasibility is a two-way street Equipment/ supplies Resources Technology Data and Evidence Complexity Competing Authority Strategy Studies and ROI Access to Patients Better Insights Copyright © Veeva Systems 2020. Veeva Confidenti
Slide 15: What does the future of study feasibility look like and how can we expedite the process?
What does the future of study feasibility look like and how can we expedite the process? Copyright © Veeva Systems 2020. Veeva Confidential. 15
Slide 16: What does the future of study feasibility look like and how can we expedite the process?
What does the future of study feasibility look like and how can we expedite the process? Internal External Response Mounting Increasing 00 Demand Need for Better Data Driven Development Process Technology for Safety Data, Approaches to Pressure Feasibility Safety Management Product Knowledge • Proto
Slide 17: The Future of Feasibility: What can sites do to expedite the process?
The Future of Feasibility: What can sites do to expedite the process? Develop a Site Profile • Eliminates the need to answer the same sponsor questions over and over Site Profile Data Collection Tool • Only complete study specific Category Question questions for sponsor Computer and Internet Are the
Slide 18: The Future of Feasibility
The Future of Feasibility Connect sites and sponsor operations Feasibility Surveys Site Profiles Sponsors and Communications Research Sites CRO’s Study Characteristics Payment Terms Visit Schedule Sponsor and CROs REDUCE ADMINISTRATIVE SPEED STUDY STARTUP BURDEN IMPROVE QUALITY Learn more during a w
Slide 19: Additional Resources
Additional Resources Click to access each resource On-demand recording Site profile template Sponsor Survey List of questions to ask your sponsor Copyright © Veeva Systems 2020. Veeva Confidential. 19
Slide 20: Questions?
Questions? Melissa Holbrook MSN, NP Mindy Muenich Bree Burks, MSN, RN Vice President, Operations Senior Director VP Strategy, Site Solutions Velocity Clinical Research Huron Consulting Group Veeva Systems Ph: 919-417-8384 Ph: 513-207-0626 Bree.burks@Veeva.com mholbrook@velocityclinical.com mmuenich@
Slide 21: Thank you
V Thank you