The Association of Clinical Research Professionals

ACRP – Avoca Quality Congress

Join Executive Leadership for this Virtual Program Exploring Patient Centricity in Clinical Trials

Part I – Thursday, September 10, 11:00am-2:00pm
Part II – Tuesday, September 15, 11:00am-2:00pm

Confirmed Participation From — AstraZeneca, IQVIA, Merck, Pfizer, PPD, Syneos Health, Clinical Trials of Texas, IACT Health, Javara Research, Starfish Harbor LLC, Advanced Clinical, Seattle Genetics, BMS, Swedish Cancer Institute, Western Washington Medical Group, and More (View Speaker Listing >)

Program Description

Adding Electricity to Patient Centricity: Energizing Solutions

Join executives and other key leaders from sites, sponsors, CROs, and tech providers as we examine recent trends for the use of patient-centric tools and technology and the associated successes, challenges, and barriers for integrating adoption across sponsors, CROs, tech providers, sites, and patients.

During this online, interactive symposium, participants will develop specific action plans to strategically align stakeholders and ensure appropriate implementation of these tools via all stakeholders in the clinical research environment.

Program Schedule —Thursday, September 10

11:00 – 11:10 am
Welcome and Introductions 

  • Jim Kremidas: Executive Director, ACRP

  • Janice Hutt, Vice President, The Avoca Group

11:10 – 11:40 am
Survey Says: Clinical Trials in the Digital Age Impact All Stakeholders More than Originally Imagined

As the clinical research industry adopts technologies that are carving new pathways for study operation and execution, it is crucial that we consider the impact and reality of implementation on sites, sponsors, CROs, and patients alike. There is a lot of anticipation regarding what this future will look like. Join ACRP and Avoca as we share data from several recent ACRP and Avoca surveys that shine a light on industry trends, technologies to keep an eye on, the status of site education and implementation, and the concerns of and advantages to sites globally.  We will examine research trends as it relates to technology and the decentralization of studies and the associated successes, challenges, and barriers for integration across sponsors, CROs, tech providers, sites and ultimately – patients.

  • Beth Harper, Workforce Innovation Officer, ACRP LinkedIn Profile Link

  • Cristin MacDonald, Vice President Client Delivery, The Avoca Group LinkedIn Profile Link

This session is generously sponsored by Complion

11:40 am – 12:50 pm
Panel Discussion

How could sponsors, providers, sites, technology companies, and patients collaborate to overcome challenges or barriers and capitalize on benefits identified within the survey for decentralized trials?

  • Steve Whittaker: President, PharmaPM Consulting (Facilitator) LinkedIn Profile Link

  • Andy Lee, SVP, Head Global Clinical Trial Operations, Merck LinkedIn Profile Link

  • Chris Frega, Vice President, Study Operations Head, Syneos Health LinkedIn Profile Link

  • Craig Lipset, Managing Partner, Clinical Innovation Partners LinkedIn Profile Link

  • Kay Scroggins, RN, President/CEO, Clinical Trials of Texas LinkedIn Profile Link

  • Kristin Smedley, Founder of Curing Retinal Blindness Foundation LinkedIn Profile Link

This session is generously sponsored by Schlesinger Group

12:50 – 1:50 pm
Panel Discussion

How can the clinical trial ecosystem proactively prepare each stakeholder group (sponsors, providers, sites, technology companies, and patients) to rapidly and effectively adopt these changing technologies?

  • Steve Whittaker: President, PharmaPM Consulting (Facilitator)

  • Jeremy Price, Director, Clinical Innovation & Strategic Partnerships, Pfizer LinkedIn Profile Link

  • Amy Klawitter, Director, Integrated Clinical Management, Evotec LinkedIn Profile Link

  • Christine Senn, Chief Operations Officer, IACT Health LinkedIn Profile Link
  • T. J. Sharpe, Patient Engagement Program Manager, Medidata  LinkedIn Profile Link

1:50 – 2:00 pm
Day One Wrap Up

  • Steve Whittaker: President, PharmaPM Consulting

Program Schedule — Tuesday, September 15

11:00 – 11:10 am
Welcome and Introductions 

  • Jim Kremidas: Executive Director, ACRP

  • Patricia Leuchten: CEO and Founder, The Avoca Group

11:10 am – 12:10 pm
Review of Avoca Quality Consortium® Tools Roundtable

Get an overview of the Avoca Quality Consortium®’s set of Patient-Centric/Site-Centric tools and engage in an online discussion and review of the tools. The audience will have opportunities to respond to polling questions as each tool is reviewed, ask questions, and make suggestions using the Chat feature on the viewing platform. Attendees will be able to keep the tools and implement them as appropriate.

Roundtable Facilitators:

  • Steve Whittaker: President, PharmaPM Consulting

  • Brigid Flanagan, BA, RN, CCRC, MSB, Senior Consultant, The Avoca Group LinkedIn Profile Link

Panel Members:

  • Susan Donahue, Senior Director, Operational Quality, Javara Inc. LinkedIn Profile Link(Tool: Clinical Site Source Document Management Standards)

  • Jeri Burr, Executive Director, Utah Trial Innovation Center LinkedIn Profile Link(Tool: Clinical Site Investigator Trial Oversight Supervision Standards)

  • Joshua Petersen, Manager, Clinical Quality Consultants, Sarah Cannon LinkedIn Profile Link(Tool: Clinical Site Protocol Deviation Management Standards)

  • Fatemeh Jami, Director of Quality, The Medical Research Network LinkedIn Profile Link(Tool: Introduction to Quality Management Systems for the Clinical Investigator Site)

12:10 – 1:30 pm
Leadership Roundtable: A Look at the News; Facts or Fiction?

Leaders from Sponsors, Sites, CROs, Advocacy Groups, and Technology Providers will take part in a roundtable focused on challenges and opportunities resulting from emerging trends (e.g. the impact of COVID-19 and continuity of trials) that impact patients and sites as the industry moves towards more “virtual” or “decentralized” clinical trials (i.e.: BYOD, Telemedicine, eCOA, eSource, eConsent, Home Nursing, UP Home Delivery, and New Players including Google, Apple, and Walmart.)

  • Steve Whittaker: President, PharmaPM Consulting (Facilitator)

  • Stephanie Abbott, Research Director at Western Washington Medical Group LinkedIn Profile Link

  • Jennifer Byrne, CEO Javara Research LinkedIn Profile Link

  • Grace Crawford, Global Head of Clinical Quality and Compliance, AstraZeneca LinkedIn Profile Link

  • Betsy Fallen, RN, Consultant with the FDA Group; MasterControl Strategic Partner LinkedIn Profile Link

  • Sharon Hanlon, Head, Clinical Trial Engagement & Contract Management, BMS LinkedIn Profile Link

  • Evonne Lackey, BA, CCRP, Director of Clinical Research, Swedish Cancer Institute LinkedIn Profile Link

  • Andy Lee, SVP, Head Global Clinical Trial Operations, Merck

  • Tim Rich, Executive Director, Innovation and virtual trial operations, PPD LinkedIn Profile Link

  • Ana Santos Alejandro, Director, Corporate Quality Relationships, Syneos Health LinkedIn Profile Link

  • T. J. Sharpe, Patient Advisor, Starfish Harbor

This session is generously sponsored by Wake Forest University and the Wake Forest School of Medicine.

1:30 – 1:40 pm
Meeting Close: Wrap up, Review of Potential Solutions, and Next Steps

  • Steve Whittaker: President, PharmaPM Consulting, LLC

1:40 – 2:00 pm
ACRP-Avoca Quality Awards

Join us as we recognize Sponsors and CROs who provide high-quality support to streamline clinical trial operations at the site level.  Finalists were chosen by investigational sites through a research study conducted by The Avoca Group.

  • Caryn Laermer, Executive Director, Client Engagement, The Avoca Group

Finalists for the ACRP-Avoca CRO Quality Award include:

  • Covance Inc.
  • ICON plc
  • PRA Health Sciences

Finalists for the ACRP-Avoca Sponsor Quality Award include:

  • AstraZeneca plc
  • GlaxoSmithKline plc
  • Novo Nordisk A/S

This session is generously sponsored by Javara.

Speakers

Jim Kremidas, ACRP

Jim Kremidas, ACRP Executive Director

Patricia Leuchten, The Avoca Group

Patricia Leuchten: CEO and Founder, The Avoca Group

Steve Whittaker, Facilitator

Steve Whittaker: President, PharmaPM Consulting

Beth Harper, Workforce Innovation Officer, ACRP

Cristin MacDonald, Vice President Client Delivery, The Avoca Group

Andy Lee, SVP, Head Global Clinical Trial Operations, Merck

Chris Frega, Syneos Health

Chris Frega, Vice President, Study Operations Head, Syneos Health

Craig Lipset, Managing Partner, Clinical Innovation Partners

Kay Scroggins, RN, Clinical Trials of Texas

Kay Scroggins, RN, President/CEO, Clinical Trials of Texas

Kristin Smedley, Founder of Curing Retinal Blindness Foundation

Jeremy Price, Director, Clinical Innovation & Strategic Partnerships, Pfizer

Amy Klawitter, Director, Integrated Clinical Management, Evotec

Christine Senn, IACT Health

Christine Senn, Chief Operations Officer, IACT Health

TJ Sharpe, Starfish Harbor

T. J. Sharpe, Patient Engagement Program Manager, Medidata

Brigid Flanagan, BA, RN, CCRC, MSB, Senior Consultant, The Avoca Group

Janice Hutt, The Avoca Group

Janice Hutt, Vice President, Client Engagement, The Avoca Group

Caryn Laermer, The Avoca Group

Caryn Laermer, Executive Director, Client Engagement, The Avoca Group

Susan Donahue, Senior Director, Operational Quality, Javara Inc.

Jeri Burr, Executive Director, Utah Trial Innovation Center

Fatemeh Jami, Director of Quality, The Medical Research Network

Stephanie Abbott, Western Washington Medical Group

Stephanie Abbott, Research Director at Western Washington Medical Group

Jennifer Byrne, Javara Research

Jennifer Byrne, CEO Javara Research

Grace Crawford, AstraZeneca

Grace Crawford, Global Head of Clinical Quality and Compliance, AstraZeneca

Betsy Fallen, Consultant with the FDA Group

Betsy Fallen, RN, Consultant with the FDA Group; MasterControl Strategic Partner

Sharon Hanlon, BMS

Sharon Hanlon, Head, Clinical Trial Engagement & Contract Management, BMS

Evonne Lackey, BA, CCRP, Director of Clinical Research, Swedish Cancer Institute

Tim Rich, PPD

Tim Rich, Executive Director, Innovation and virtual trial operations, PPD

Ana Santos Alejandro, Syneos Health

Ana Santos Alejandro, Director, Corporate Quality Relationships, Syneos Health

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