techXpo hosted by SLOPE: Operational Overload: Tools to Manage Complexity and Reduce Stress

Apr 23, 2022 10:30am ‐ Apr 23, 2022 11:15am
Expiration Date: May 30, 2024

Identification: 5004

Credits: None available.


Rapid-Fire Sessions

Apr 23, 2022 2:15pm ‐ Apr 23, 2022 3:15pm
Expiration Date: May 30, 2024

Identification: 2000

Credits: None available.


FDA Inspections: Understand the Process and Manage the Consequences

Apr 23, 2022 2:15pm ‐ Apr 23, 2022 4:15pm
Expiration Date: May 30, 2024

Identification: 118

Credits: None available.

This very interactive session has been popular with attendees. Part 2 (the hands on piece) involves several actual FDA cases -- warning letters, NIDPOEs, 483s -- for the group to respond to on a provided CAPA form. The attendees will be divided into groups and given time to read their assigned case and use one of the root cause analysis tools to develop an appropriate CAPA. The groups will debrief with commentary from the other participants and facilitators.
Learning Objectives:
  • Describe at least 3 regulatory actions FDA can take following an inspection
  • Discuss appropriate strategies for responding to inspection findings
  • Implement realistic and appropriate Corrective and Preventive Actions to successfully resolve inspection findings

No More Boring Training Webinars-Virtual Classroom Training - The 6 Ps for Success!

Apr 23, 2022 2:15pm ‐ Apr 23, 2022 3:15pm
Expiration Date: May 30, 2024

Identification: 146

Credits: None available.

Core challenge: With the onslaught of the pandemic in 2021 - many CRPs have had to deliver their site training, team training, staff training and organizational training via the internet. And, many CRPs have identified 'they don't know, what they don't know' to develop and deliver engaging and efficient 'virtual classroom training'..that is not a 'one way lecture' with a few knowledge checks and chat box/Q&As. Liz and Barb are going to share the 6 TIPS for success - called the 6 Ps - that are the foundation for successful virtual classroom training- emulating an in-person training class! Our speakers' have expertise with virtual classroom training, and curating numerous references, and technology solutions and will equip the participants - that will WOW the attendee to say 'I can do this'...'I now have the roadmap'..and I don't have to spend thousands of dollars, hours reading and attending 'free webinars' that don't give a 'deep dive'. Liz and Barb are teaching the 6 Ps Presence Presentation Preparation Planning Platform Producer This is a critical skill/ability/behavior for CRPs to master because remote work and decentralized clinical trials are in the forefront right now - and CRPs need and want to know 'am I enaging the participant to learn, using their critical thinking' via course design, visual presentation and delivering the course in a manner that fosters building an online learning community. Participants will develop and deliver impactful, performance - based virtual classroom trainings with a WOW factor!

Learning Objectives:
  • Understand the landscape and components of simple and complex hybrid/decentralized trials
  • Prepare for operation of decentralized trials in start-up and on-going support
  • Recognize the future evolution towards regulatory approval of digital endpoints and patient-focused drug development

Risk, Results, and Regs: Managing a Clinical Strategy

Apr 23, 2022 2:15pm ‐ Apr 23, 2022 3:15pm
Expiration Date: May 30, 2024

Identification: 162

Credits: None available.

We are addressing how to develop and manage a clinical strategy for small to mid-size companies from a regulatory, risk, and results perspective. When working with smaller companies, members of a study team may have to serve in a number of roles, some of which may be new or unfamiliar. In addition, the outcomes of a trial may take on a greater importance if the medical device being studied is the primary product under development by a company. Our presentation will discuss the value of a drafting a regulatory/product development strategy early in clinical development, managing risk throughout a trial, and balancing clinical vs. non-clinical priorities related to outcomes. Although the focus of the presentation will be for medical device companies and CROs, the content will provide methods/practical tips sites can use when working on these studies.
Learning Objectives:
  • Understand the value of developing and implementing a regulatory strategy early in the clinical development process
  • Examine the importance of establishing and managing study risk
  • Learn how to balance study results from a clinical and non-clinical perspective

Strategies for Taking " Big Swings of Bold" in Research Ops

Apr 23, 2022 2:15pm ‐ Apr 23, 2022 4:15pm
Expiration Date: May 30, 2024

Identification: 104

Credits: None available.

The core challenge this course which I am open to being a Master Class or a one hour presentation or both, is to present the tools and for creating and implementing strategies across research administration that lead to improvements, greater efficiencies and the implementation of the innovation. Using the BOLD (Believe-Own-Learn-Design) Framework attendees will be able to apply the learnings to their roles in research across multiple strategic scenarios.
Learning Objectives:
  • Use the BOLD Framework to create their BOLD plan for the implementation/innovation of their choice using the learnings and tools from the presentation
  • Create new pathways and strategies for planning for efficiencies in research operations and administration through a new lens that encourages agile change
  • Apply the principles of design to innovate and plan for new strategic outcomes in research operations and administration

techXpo hosted by Verily: Research Rewired - Reimagining Clinical Evidence Generation for Precision Health

Apr 23, 2022 2:15pm ‐ Apr 23, 2022 3:15pm
Expiration Date: May 30, 2024

Identification: 5015

Credits: None available.

Amy Abernethy MD PhD is the President of Verilys Clinical Studies Platforms, where she oversees the companys clinical evidence generation platform product vision and related clinical research portfolio. In this session, Dr. Abernethy will draw upon her prior experiences as the Principal Deputy Commissioner at the FDA, the agency's acting Chief Information Officer, the former Chief Medical and Chief Scientific Officers of Flatiron Health, and as a research leader at Duke University, to discuss how clinical research needs are evolving and how Verily is building towards a superior evidence generation platform. She will discuss Verily's recent acquisition of SignalPath, how SignalPath's state-of-the-art clinical trial management system (CTMS) can improve the ease, quality and efficiency of conducting clinical research at study sites, and how Verily's growing Clinical Studies Platforms plans to set a new standard for clinical studies and evidence generation.


Investigator Oversight of External Parties (ICH GCP E6 R2): Compliance Tips and Tools for Sites!

Apr 23, 2022 3:30pm ‐ Apr 23, 2022 4:30pm
Expiration Date: May 30, 2024

Identification: 5057

Credits: None available.

Investigators/institutions might need to hire an external party (physician specialist, or laboratory, EKG facility) to execute a clinical trial. Regulatory authority inspections have noted that the Investigator/Institution's lack of systematic, and comprehensive assessments prior to trial start and during the clinical trial has impacted both participant safety and reliability of the data generated by the Investigator. Get the insight and tools needed to: Evaluate current organizational practices against industry practices for selection and oversight of external parties by the Investigator; Distinguish industry practices, procedures and tools needed for both external party selection and oversight; and Construct the framework for effective and compliance external party oversight program.

Oversight from a Distance: How to Set Site Leadership up for Success in Virtual and Hybrid Trials

Apr 23, 2022 3:30pm ‐ Apr 23, 2022 4:30pm
Expiration Date: May 30, 2024

Identification: 141

Credits: None available.

This presentation will address the hot topic of decentralized clinical trials, but from a view that is often underserved: the clinical trial site. Conducting virtual and hybrid trials requires the principal investigator (PI) and clinical research coordinator(s) to adopt new methods for managing a study team that might not be co-located. In order to remain competitive in this evolving landscape, it is a business necessity for sites to gain the requisite skills needed to communicate and manage a remote team, as well as maintain essential documents in a manner compliant with relevant regulations. Attendees of this session will walk away with practical knowledge for developing a site-level communication plan or PI oversight plan to ensure effective management of fully virtual and hybrid trials. In addition, attendees will understand the core aspects of how to remain in compliance when maintaining site-level documentation electronically.
Learning Objectives:
  • Create a plan for site-level oversight that meets the unique needs of virtual and hybrid trials.
  • Communicate and train site staff effectively in a remote environment.
  • Develop systems for electronic management of site-level documentation in compliance with regulatory requirements.

Sprinkle a Little Pixie Dust – Developing a Project Manager Training Program

Apr 23, 2022 3:30pm ‐ Apr 23, 2022 4:30pm
Expiration Date: May 30, 2024

Identification: 108

Credits: None available.

The challenge we are addressing is the establishment of adequate training programs for clinical research roles, specially the role of project management. Project management is such a unique field that it is essential for organizations to have a training toolkit to use to establish a good foundation and continue professional growth for project managers. The audience will be able to walk away with how to implement a training program for project managers and understand their return on investment.
Learning Objectives:
  • Describe the project management role in clinical research.
  • Review an established training program for project managers.
  • Apply the tools learned to brainstorm and create how best to implement at your site.