SOCRA 2023 Annual Conference Brochure - Flipbook - Page 11
FRIDAY, SEPTEMBER 29, 2023
BREAKOUT SESSIONS
TRACK 2: DEVICE RESEARCH
Time: 1:15 to 2:50
Track: Device
Developing a Quality Management System at a Clinical
Site: A Case Study
With the release of the ICH E6(R2) GCP guideline in
November of 2016 and regulatory agencies' expectations
of a quality management system (QMS) approach to the
conduct of regulated clinical trials, many sponsors are
quickly adapting such an approach. At this time, the same
cannot be said of many clinical research sites. This
presentation will describe a clinical site that chose to
apply a QMS approach, along with the trials and
tribulations it faced along the way. We will describe the
actual process, including the difficulties and challenges
faced. The presentation will also outline the positive
outcomes experienced since applying such an approach
and what future activities will be needed to ensure
maintenance of the QMS approach. 209 / 211
Presenters: Marcus Stone, PhD, ACRP-CP, Director of
Clinical Research, Spine Institute of Louisiana Foundation
Lee Truax-Bellows, MS, FNP, CCRA, RQAP-GCP, TIACR,
President and CEO, Norwich Clinical Research Assoc., Ltd.
Time: 3:25 to 4:10
Track: Device
The Transition from GLP to GCP: The Benefits of
Designing Pivotal Large Animal Studies to Better Reflect
the Design of Future Clinical Trials in Humans
Good Laboratory Practice (GLP) studies can be more than
just one of the boxes you need to check off in order to
receive regulatory approval to initiate a human clinical
trial with your company's new medical device. Large
animal GLP studies are mainly used to support the filing of
IDE/ITAs, but they can be designed to provide additional
valuable information that can increase the chances of
human trial success. GLP studies are traditionally designed
to provide safety and efficacy data with an emphasis on
safety, on the use of a medical device, but these studies
can also be designed to collect information for areas such
as reimbursement, clinical adoption, human factors, risk
evaluation and mitigation, and transportation and storage
logistics; all important factors in the successful
development of any new medical device. It is all about
making sure that you maximize every opportunity to
collect information related to your company’s new medical
device. 213
Presenter: Michael Jamieson, DRSc, Advisor, Research &
Innovation Partnerships, Queens University
TRACK 3: INVESTIGATORINITIATED RESEARCH
1:15 to 2:00
Track: IIR
Setting Up Your IIS Program for Success – From
Ideation to Dissemination
Investigator-initiated studies (IISes) are clinical
investigations that are developed by physicians. A
successful IIS program requires certain elements to
ensure that studies are well-designed, scientifically
sound, address an important knowledge gap, and
provide reliable, high-quality data on which to draw
conclusions and insight. The right team will work
collaboratively with the physician investigator to take a
concept from ideation to study startup and from data
analysis to dissemination. 309
Presenter: Amy Starosciak, PhD, Director of Research
Concept & Protocol Development, Miami Cancer
Institute
Time: 2:05 to 2:50
Track: IIR
Why does it have to be so complicated? How a crossfunctional Feasibility Review carves a pathway to study
success.
In a competitive research environment, it is critical to
get a study through the startup process efficiently with a
strong, feasible and well-written protocol. The University
of Minnesota’s Clinical Research Support Center
designed and implemented a structured Feasibility
Review process that addresses startup challenges and
efficiently helps investigators develop protocols ready
for IRB submission and successful execution. The
Feasibility Review is a valuable, cross-functional
program providing timely expert guidance for study
teams to efficiently and successfully launch and execute
clinical research studies. Feasibility Review can be
easily replicated, adapted, and implemented at other
institutions to increase the quality and efficacy of
academic research. 311
Presenter: Nicole Tosun, MS, CCRP, Senior Clinical
Research Specialist, University of Minnesota
Time: 4:15 to 5:00
Track: Device
Metal Hypersensitivity Reactions to Implantable Devices
This presentation will provide an overview of
hypersensitivity reactions to metal, review of the evidence
and findings from a recent qualitative study on the
experiences of people with metal hypersensitivity. 215
Presenter: Dzifa Dordunoo, PhD, MSN, BSN, RN, Assistant
Professor, University of Victoria
SOCRA ANNUAL CONFERENCE BROCHURE
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