Cambridge Healthtech Institute’s 7th Annual

Improving Study Start-Up, Site Activation and Trial Performance  

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

February 20-21, 2020


Clinical trial site activation and efficient study start-up for both site-based and remote/de-centralized trials 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 to improve: the study feasibility process, site investigator’s experience, consent process, rollout and implementation of technologies across a study, contract and budget negotiations, payments, and development of patient recruitment and retention programs. Understanding and planning for the challenges faced by your study participants, investigators, sites and industry partners is the key to improving trial efficiencies and outcomes. Knowing when and where to use and to effectively scale technology is now a must in the age of digital trials. CHI’s 7th Annual “Improving Study Start-Up, Site Activation and Trial Performance” will cover the topics one should consider when strategically implementing a process for rapid study start-up, whether with sites or for de-centralized trials.

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

Preliminary Agenda

SITE ENGAGEMENT DURING FEASIBILITY PROCESS & IMPROVING START-UP TIMELINES WITH ADVANCED PLANNING FOR EARLY AND LATE-STAGE TRIALS

Site Engagement During the Site Feasibility Process and Impact on Study Start-Up Timelines

Mary-Anne Tomas, Director, Site Intelligence & Selection, Study Optimization, Global Product Development, Pfizer

INTERACTIVE PANEL: Sponsor and Site Interactions in Phase 1 Site Selection, Recruitment and Contract Negotiations

Kristi Womack, Director, Clinical Pharmacology Operations, Allergan
Mark Scheetz, Associate Director, Program Lead for Phase I Studies, Allergan
Site Panelists TBD

IMPROVING SITE SELECTION, ENGAGEMENT AND PROCESS: CONSENT, EHR PLATFORMS, CONTRACTING & DATA-DRIVEN COURSE CORRECTION

CASE STUDY CO-PRESENTATION: Create and Control: BI's move to a DIY Consent Process

Kristen Signs, Senior Associate Director, Clinical Operations, Boehringer Ingelheim

Eric Delente, Head, Patient Consent, IQVIA Technologies

CO-PRESENTATION: Lessons Learned in Site Selection and Site Engagement Using EHR Platforms

Doug Schantz, Executive Director, Clinical Operations, AstraZeneca
Chrystal Oley, Associate Director, Site Partnerships, AstraZeneca

Navigating the Study Start-up Labyrinth: Is Site Activation a Hostage to Contracting?...and How to Avoid It

Ivana Matic, MD, Global Site Agreements Director, Global Clinical Trial Operations, Merck & Co.

When Data Drives Intervention…An Analytics Approach to Site Level Acceleration and Trial Course-Correction

Angelique Hopkins, Director, Clinical Trial Analytics, Business Insights and Analytics, Bristol-Myers Squibb Company

FACILITATING THE TRIALS OF THE FUTURE NOW VIA THE CONNECTED PATIENT & DECENTRALIZED TRIALS

The Connected Patient: A "One Stop Shop" for Trial Information and Data

Megan McBride, MPH, Associate Director, Janssen Clinical Innovation, GCDO, R&D, Janssen, The Pharmaceutical Companies of Johnson & Johnson

INTERACTIVE PANEL: Translating Virtual to Reality: Decentralized Trial Transformation

Moderator: Jane Myles, Head, Operational Intelligence and Innovation, Roche
Bardia Akbari, PharmD, Senior Vice President, Clinical Operations, Science37
FDA Representative to be Confirmed

PLENARY KEYNOTES

Tuesday Evening, Wednesday Morning, Wednesday Afternoon Plenary Keynotes Featuring:

SCOPE’s 2020 Participant Engagement Award, in Memory of Jerry Matczak
Patient Perspectives as an Input to Feasibility and Clinical Trial Design
Digital Trends that Are Changing Clinical Research
Health Literacy Throughout Drug Development – Why It Matters to Pharma and to Patients
Implementing an Innovation Methodology to Accelerate Clinical Trial Innovation within Your Organization

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

INTERACTIVE BREAKOUT DISCUSSION GROUPS

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing: www.scopesummit.com/breakouts

 

Arrive early and attend Part 1 (Wed - Thurs): 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: (+1) 541. 482.4709
Email: mlieberman@healthtech.com

 

For partnering and sponsorship information, please contact:

Companies A-K

Ilana Quigley

Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781.972.5457

Email: iquigley@healthtech.com

 

Companies L-Z

Patty Rose
Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

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