Name: Clinical Quality Oversight
Start: 22/05/2024 10:00 AM +00:00
End: 23/05/2024 11:00 PM +00:00

inSeption Group is a leading global outsourcing company renowned for its exceptional service and commitment to quality. In today&rsquo;s rapidly changing industry, those values mean more than ever before.
At the core of inSeption Group&rsquo;s success is its ability to identify, engage, and retain experienced individuals dedicated to establishing quality structures and streamlined approaches for managing critical trial documents. Teams hold themselves to a high degree of excellence, efficiency, and strategic stewardship, and this unique culture means your records are complete, accessible, and inspection-ready at all times.

inSeption Group

ZS is a management consulting and technology firm focused on transforming global healthcare and beyond. We leverage our leading-edge analytics, plus the power of data, science and products, to help our clients make more intelligent decisions, deliver innovative solutions and improve outcomes for all. Founded in 1983, ZS has more than 12,000 employees in 35 offices worldwide. To learn more, visit https://www.zs.com/or follow us on Twitter and LinkedIn.

Welcome to Clinical Trial Vanguard, the premier platform for in-depth insights, current news, and thorough analysis in the world of clinical trials.
What Sets Us Apart
<ul>
<li>Expert Analysis: Spearheaded by industry luminaries, we provide a unique perspective on clinical trials, ensuring our readers are always a step ahead.</li>
<li>Timely News: Our dedicated team ensures you&rsquo;re updated with the latest happenings and breakthroughs in clinical trials.</li>
<li>In-depth Insights: Dive deep into topics ranging from the latest technologies in healthcare to the evolving methodologies in clinical research.</li>
<li>Comprehensive Analysis: Beyond just reporting, we dissect and interpret the implications of new developments, providing a 360-degree view of the clinical trial landscape.</li>
<li>Conference Coverage: Be at the forefront of innovation with our real-time coverage of major clinical trial conferences, ensuring you never miss out on key insights and developments.</li>
</ul>
At Clinical Trial Vanguard, our commitment is to empower professionals with the most accurate news, detailed analysis, and profound in-depth insights related to clinical trials. Whether you&rsquo;re a seasoned researcher, industry professional, or an enthusiast, we&rsquo;re here to be your trusted companion in navigating the intricate world of clinical research.
Join our community as we delve deep, analyze, and bring to you the very essence of clinical trials.

The Clinical Trial Vanguard - Clinical Trial News

Achieve confidence that your company is GCP inspection ready by walking through every step of the inspection preparation and execution process. Leave having heard directly rom the regulators themselves about inspection trends, what you need to implement to ensure you are prepared, and understand how technology and effective training can be utilized to drive a culture of quality, and a continued state of GCP inspection readiness.

Let Momentum Virtualize Your Retreat, Recruitment, Training or Client Event - As most industries continue to adjust to life with limited to no live meetings or events, the need to create a valuable and impactful experience has never been greater. Whether it is a firm retreat, recruitment effort or client event, Momentum can virtualize your program and deliver a seamlessly executed program that removes any delivery risks and enhances the digital experience, all for the fraction of the cost of a traditional venue and without any subscriptions or long-term commitments.&nbsp;
vCaaS&trade;, virtual Conference as a Service, leverages our best in class technology platform, an assortment of virtual event provider relationships, and the meticulous nature of our event planning mindset to create a customized virtual event and social interaction platform that can seamlessly deliver content to an audience of your choosing. Our services can be used for:
<ul>
<li>Law firm and company retreats</li>
<li>Client events</li>
<li>Training courses</li>
<li>Recruitment activities</li>
<li>Expert roundtables</li>
<li>Bespoke conferences</li>
</ul>
As a full-service events company, we will also consult on session design and timing for the virtual environment, leveraging best practices, and provide complete end to end project management, acting as an extension of your team and &ldquo;general contractor&rdquo; for your retreat.
We can incorporate any or all of the following elements into your event:
<ul>
<li>Keynote addresses</li>
<li>Professionally produced video content (pre-recorded or live)</li>
<li>Multiple roundtables &amp; breakouts</li>
<li>Private meeting rooms</li>
<li>Virtual cocktail receptions</li>
<li>Embedded video chat</li>
<li>1:1 Matchmaking</li>
<li>Content delivery</li>
<li>Brand activation</li>
<li>Exhibition activation</li>
<li>Social events</li>
<li>and much more&hellip;</li>
</ul>
By working with Momentum, you can sit back and rest assured that your next event will be in safe hands with an events company that has 100+ combined years of executive leadership experience and 10+ years of working with dozens of virtual event platforms.
Don&rsquo;t waste your time evaluating the hundreds of virtual event platforms currently on market or stress of how to execute your digital event at the high standard your company expects, let Momentum take all the hassle off your plate and allow you and your team to focus on your core responsibilities.&nbsp;

Conference as a Service v(CaaS™) by Momentum

Learn from a Small Company's Experience Uncovering Multiple Misconduct Issues at the CRO and Site Levels and what Actions Could Prevent a Similar Situation
<ul>
<li>Establish case study background and the heavy reliance on the CRO/CRA</li>
<li>Discuss how issues were uncovered and what could have been done differently&nbsp;</li>
<li>Outline the decision to bring monitoring in-house and what that entailed&nbsp;</li>
<li>Evaluate the outcome, impact to trial integrity, and what actions/processes are now in place as a result&nbsp; &nbsp;</li>
</ul>
Elizabeth Polvent Senior Director, Clinical Operations, ARTHROSI THERAPEUTICS, INC
Pamela Mundell Clinical Trial Manager, ARTHROSI THERAPEUTICS, INC

Elizabeth Polvent

Pamela Mundell

SMALL COMPANY CASE STUDY: A RETROSPECTIVE VIEW OF A FAILED PARTNERSHIP

Examine a Mid-Study Shift from Traditional Monitoring to a Holistic Risk-Based Approach and the Hidden Cultural Barriers to Compliance that it Uncovered
<ul>
<li>Detail the background for a Decentralized Malaria trial in Mozambique and Kenya</li>
<li>Discuss observed quality concerns and what actions needed to take place</li>
<li>Identify the elements of oversight that were missing and required to result in usable data</li>
<li>Outline cultural biases unique to certain communities impacting the quality of the data</li>
<li>Redesign the trial applying a holistic and adaptable risk-based approach to monitoring that resulted in proactive issue identification&nbsp; </li>
</ul>
Leslie Sam President, LESLIE SAM, AND ASSOCIATES, LLC
Lisa Collins CLINICAL OPERATIONS EXPERT IN NIGERIA

Leslie Sam

Lisa Collins

CASE STUDY: TRADITIONAL TO RISK-BASED

Elizabeth Polvent Senior Director, Clinical Operations, ARTHROSI THERAPEUTICS, INC
Pamela Mundell Clinical Trial Manager, ARTHROSI THERAPEUTICS, INC
Leslie Sam President, LESLIE SAM, AND ASSOCIATES, LLC
Lisa Collins CLINICAL OPERATIONS EXPERT IN NIGERIA

AUDIENCE COMMENTS AND Q&A FOR PREVIOUS SPEAKERS

Fine Tune your Quality Oversight Plan with Insight from Recent GCP Inspection Experiences and Communication with Varying Regulatory Authorities
<ul>
<li>Learn the latest inspection gossip and what this might mean for your oversight practices</li>
<li>Identify trends from recent experiences to determine the regulatory focus of different agencies</li>
</ul>
Sharon Reinhard Clinical Quality Expert, INDEPENDENT CONSULTANT
Dawn Niccum Executive Vice President, QA &amp; Compliance, INSEPTION GROUP
Reetu Dandora Vice President, AVEO PHARMACEUTICALS
Paul Houri Vice President, R&amp;D Quality, BRISTOL MYERS SQUIBB
&nbsp;
CLOSING REMARKS
Sharon Reinhard Clinical Quality Expert, INDEPENDENT CONSULTANT
&nbsp;

Agenda

Speakers16 Speakers

Cheryl McCarthy, RQAP-GCP, CQA, CMDA.

Dawn Niccum

Jolie Weintraub

Kerstin Koenig

Leslie Sam

Lisa Collins

Michael Torok

Misha Abraham

Niloy Shah

Paul Houri

Jonathan Rowe

Elizabeth Polvent

Pamela Mundell

Sharon Reinhard

Priya Chaturvedi

Reetu Dandora

Booth5 Booth

inSeption Group

ZS

The Clinical Trial Vanguard - Clinical Trial News

GCP

Conference as a Service v(CaaS™) by Momentum

Agenda

Speakers.css-2zwi6c{margin:0;font-size:1.4rem;font-weight:500;line-height:1.5;color:#494949;font-family:'Poppins',sans-serif;margin-left:0.8rem;}16 Speakers

Cheryl McCarthy, RQAP-GCP, CQA, CMDA.

Dawn Niccum

Jolie Weintraub

Kerstin Koenig

Leslie Sam

Lisa Collins

Michael Torok

Misha Abraham

Niloy Shah

Paul Houri

Jonathan Rowe

Elizabeth Polvent

Pamela Mundell

Sharon Reinhard

Priya Chaturvedi

Reetu Dandora

Booth.css-14sv5ey{margin:0;font-size:1.4rem;font-weight:500;line-height:1.5;color:#494949;font-family:'Poppins',sans-serif;color:#FFFFFF;margin-left:0.8rem;font-weight:400;}5 Booth

inSeption Group

ZS

The Clinical Trial Vanguard - Clinical Trial News

GCP

Conference as a Service v(CaaS™) by Momentum

Speakers16 Speakers

Booth5 Booth