Cambridge Healthtech Institute’s 6th Annual

Improving Site-Study Activation and Performance

Strategically Implementing Process and Systems for Rapid Study Start-Up and Improved Site-CRO-Sponsor Interactions

February 20-21, 2019


Clinical trial site activation and efficient study start-up are critical to drug development programs, in terms of time, cost and quality of data. To improve start-up times and outcomes, one needs an experienced clinical research investigator, motivated and capable team members and efficient communication by all. Everyone (Sponsor, CRO, Site) must communicate and execute effectively in order to improve: the study feasibility process, contract and budget negotiations, standardization of source documents and other study-related materials, development of patient and staff educational materials, and development of patient recruitment and retention programs. CHI’s 6th Annual “Improving Site-Study Activation and Performance” will cover the topics one should consider when strategically implementing a process for rapid study start-up.


Arrive early and attend Part 1 (Tues-Wed): Protocol Development, Global Site Selection, Feasibility and Site Management


Wednesday, February 20 - Thursday, February 21 (Part 2 of SCOPE)

BRIDGING LUNCHEON: Metrics, Standards & Technology: How to Harness Digital to Transform Protocol Creation

Bob Brindle, Venture Leader, Life Sciences, Cognizant

UNDERSTANDING THE LATEST CHALLENGES FOR STUDY START-UP AND SITE ACTIVATION IN US, EU AND ROW

New EU-Clinical Trials Regulation: Industry Preparation via Pilot Procedures

Thorsten Ruppert, MD, Senior Manager, Research, Development and Innovation, Association of Research-Based Pharmaceutical Companies (vfa)

Study Start-up Practices and Cycle Times Among Sponsors and CROs

Mary Jo Lamberti, PhD, Professor, Associate Director, Sponsored Research, Tufts CSDD

Accurate Patient Enrollment Forecasting Using EnForeSys®: Case Studies and Lessons Learned

Charles Liu, Senior Product Manager, Cytel

Site Activation, a Balancing Act between Time and Quality: How to Avoid Paying the Price Later On

Valérie Reynaert, Head, In-Country Clinical Operations for the Americas, R&D Projects Clinical Platform & Sciences, GlaxoSmithKline

IMPROVING START-UP TIMES: UNDERSTANDING SITE INVESTIGATORS’ EXPERIENCE, INFORMED CONSENT, PAYMENTS

Re-defining the Site Investigator Experience: Understanding Investigator Needs and Improving Start-up Times

Lisa Moneymaker, CTMS Process Architect, Amgen

Site Management Approaches in Gene Therapy & Rare Disease Clinical Trials: A Collaborative Approach to be a Sponsor of Choice

John Makowski, Head, Clinical Operations, Audentes Therapeutics

Transforming Informed Consent: Current Landscape and Tools to Enable the Future of eConsent

Cassandra Smith, MBA, Associate Director, Investigator and Patient Engagement, Janssen

CO-PRESENTATION: Improving Site-Study Activation and Study Timelines through Harmonizing Budgeting, Contracts, Data, and Payments

Bill Karich, Strategic Business Operations, CSL Behring

Trent Farmer, Contract Manager, Attorney, CSL Behring

BUILDING CAPABILITIES FOR IMPROVED SITE ACTIVATION AND CYCLE TIMES

CASE STUDY: GSK’s Journey of Launching a Formal Study Start-up Department

Christine Crandall, Head of Strategic Clinical Planning, Study Start Up, R&D Projects Clinical Platforms & Sciences, GSK

OPTIMIZING SITE-CRO-SPONSOR INTERACTIONS: UNDERSTANDING PATIENTS, SITES, PROCESS & TECHNOLOGY TO IMPROVE TRIALS
(Shared Session)

CASE STUDY: The Sites First Initiative: Understanding Patients and Site Relationships to Improve Trials

Marisa Rackley, Director, Clinical Development Execution, Vertex Pharmaceuticals

INTERACTIVE PANEL: Moving from Technology Indigestion to Workable Solutions

Moderator: David Vulcano, LCSW, MBA, CIP, RAC, Vice President Research Compliance & Development, HCA

Panelists: Stephanie Abbott, PharmD, Clinical Research Program Director, Western Washington Medical Group

Jeewa Perera, CEO, Champ IT Solutions

Additional Panelists to be Announced

Luncheon Presentation (Sponsorship Opportunity Available)

PLENARY KEYNOTES


Monday Evening, Tuesday Morning, Wednesday Afternoon Plenary Keynotes Featuring:
 
SCOPE’s 2019 Participant Engagement Award, in Memory of Jerry Matczak
Empowering Humans to Own Their Own Data
Digital Trends That Are Changing the Healthcare Experience
Why Do We Need Caregivers in Clinical Trials; Exploring Real-life Applications in Engagement and Retention
Welcome, Pharma, to AI. Here’s What You Have Been Missing.
 
For more details on the Plenary Keynotes: www.scopesummit.com/keynotes
For more details on the Participant Engagement Award: www.scopesummit.com/participant-engagement-award


Arrive early and attend Part 1 (Tues-Wed): Protocol Development, Global Site Selection, Feasibility and Site Management


For more details on the conference, please contact:
Micah Lieberman

Executive Director, Conferences

Cambridge Healthtech Institute (CHI)

Phone: 541.482.4709
Email: mlieberman@healthtech.com

For partnering and sponsorship information, please contact:

Companies A-O

Ilana Quigley

Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: 781.972.5457

Email: iquigley@healthtech.com

Companies P-Z

Patty Rose
Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781.972.1349
Email: prose@healthtech.com 


Signature Sponsor

IQVIA


Premier Sponsors

Appian

Bioclinica_new

ClinicalInk

Covance

DrugDev

ERT

PRA Health Sciences

Praxis

Syneos Health

UBC

Veeva