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
Thursday, February 20
11:30 am Registration Open (Regency Rotunda)
12:30 BRIDGING LUNCHEON PRESENTATION: Humanizing Patient Engagement through Behavioral Sciences
David Kiger, Chief Commercial Officer, Datacubed Health
During this presentation, we will describe the advantages of modern design and UX (user experience) concepts, like those used in consumer apps. We will show how these standard modern approaches yield a more rewarding patient-centric experience. We
will describe several innovative concepts used to nudge and track patients, to create a 360-degree experience for participants, clinical sites, and primary care physicians.
1:00 Coffee and Dessert Break in the Exhibit Hall (Windermere Ballroom)
2:00 Afternoon Plenary Keynotes (Regency Ballroom S)
3:10 Booth Crawl & Refreshment Break in the Exhibit Hall. Last Chance for Exhibit Viewing (Windermere Ballroom)
4:10 Chairperson’s Remarks
Rick Arlow, Founder, CEO, Complion
4:15 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
This presentation will look into the impact of insourcing site intelligence and site engagement for site feasibility from a sponsor point of view. It will examine the impacts of site relationships on study start-up timelines and success. It will
also highlight approaches with respect to site architecture, therapeutic alignment, and methods of approach.
4:45 CO-PRESENTATION: Avoid Your Next Horror Story - Innovative Solutions to Prepare Sites for Study Execution
Michael Brooks, President,
Clinical Development and Commercialization Services, Covance Drug Development,
Wael Abouelkheir, MBA,
Global Studies Leader, Global Product Development, Neuroscience, Roche
Increases in clinical trial complexity have introduced new risks for delayed site activation, protocol deviations, costly remonitoring, and compromised data quality. Commiserate with our panel of industry leaders about inadequately prepared sites.
Our panel will discuss innovative solutions to operational risk assessments and share advice on how to proactively equip your site staff to prevent critical mistakes before they happen.
5:15 Avoid Rescue Studies,
Reduce Costs and Timelines, and Accelerate Clinical Operations with Metrics
Elvin Thalund, Director,
Industry Strategy, Oracle Health Sciences, Oracle, Inc
You can’t manage what you don’t measure. Granular real-time metrics provide operational insights allowing you to take control of your studies by being proactive instead of reactive. Drive competitive performance and operational excellence
by focusing your resources on bottlenecks and processes ripe for optimization. Introduce efficient resource allocation and parallelization of operational activities that can significantly compress operational timelines, improve downstream
quality and regulatory compliance, while speeding entry to market.
5:45 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
Carol Miller, Senior Director, Business Development, Spaulding Clinical Research
Phase 1 doesn’t fit into the late Phase mold. Start-up is much quicker and procedures differ for these studies. Study enrollment goals and duration are much shorter than most late phase studies. Discussions pertaining specifically to Phase
1 are lacking and there is a need for discussion on these topics within the clinical operations community. This panel is an open dialogue between Sponsor representatives and site representatives sharing “what works” and the lessons
are relevant to those working in both early and late phases:
- Site selection process from the sponsor point of view
- Meeting recruitment and retention goals: How Phase 1 centers distinguish themselves to retain a healthy volunteer database, and how do we find the special patient populations?
- Maintaining strong sponsor and site relations: How does contracting play a role?
6:15 Networking Reception (Regency Rotunda)
7:15 Close of Day
Friday, February 21
7:15 am Registration Open (Regency Rotunda)
7:45 BREAKFAST PRESENTATION: Breaking
Down the Roadblocks to Site Activation (Regency Ballroom T)
Johnston President, Study Planning & Site Optimization, WCG
8:15 Session Break
8:20 Chairperson’s Remarks
Gen Li, PhD, MBA, President & Founder, Phesi
8:25 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
Boehringer Ingelheim took a major step and insourced their consent process with a SaaS technology so they could create, manage, distribute, control and report on consent documents all in-house. BI will discuss their journey, including why they
decided to go this direction, managing change within their organization, reactions from sites and ethics committees, the successes and struggles of their implementation and pilot trials, and the importance of early adopters in driving transformational
8:55 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
In 2019 AstraZeneca began to explore how to make smarter site selection decisions by leveraging electronic health record systems capability to pre-identify potential participant clusters. We discovered that the success of this strategy is rooted
in three primary drivers: technology platform capabilities, data access across multiple institutional platforms and institutional line-of site across the patient care delivery system. Our findings suggest that although the technology capabilities
are important the drivers are the human factors: leadership support of cross institutional database access and institutional line of site into patient care access points. Successful implementation of an EMR strategy is achievable but awareness
of an individual site’s commitment to this process is essential to converting the numeral data to patient lives impacted by clinical research.
9:25 Navigating the Study Start-Up Labyrinth: The Importance of Upfront Planning and Cross-Functional Alignment to Efficient Site Contracting
Christina Greene, Esq., Associate Director, Global Site Agreements, Merck Sharp & Dohme Corp.
CTA execution is an essential element to activating an industry-sponsored clinical trial at a clinical site, yet site contracting and budgeting remain one of the top reasons for delayed site activation. What are the root causes and how can it
be avoided? Which techniques and approaches should we apply to avoid excessive delays in study start-up? What are we (sponsors, CROs, sites) doing together to avoid unnecessary delays and what are we missing? Learn about efficiency improvement
opportunities in contracting aspects of study start-up.
9:55 Reducing the Administrative Burden on Sites
Larissa Comis, Product Lead, Shared Investigator Platform Life Sciences
Products & Platforms, Cognizant
Every sponsor wants to make life easier for investigators, but what are the initiatives that are delivering measurable benefits today? This session will share the practices that are truly making a difference. Use cases of solutions that have
proven to reduce investigator frustration, burnout, and drop-out will be explored.
10:25 Networking Coffee Break (Session Room Foyer)
10:55 Chairperson’s Remarks
Linda Glaser, MD, PhD, Medical Director, Coastal Biomedical Research
11:00 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
There are weak link sports (soccer) and strong link sports (basketball), the best method for improving performance in each situation depending on whether investing in the worst component of a team or the greatest strength on a team makes the biggest
difference. For years the preferred method for accelerating clinical trials and improving site performance has been to focus on the highest performing sites. Using trial simulation and modeling techniques, we can see how a “weak link”
approach to site performance (focusing middle and lower tier sites) may be a better although less intuitive method for increasing performance and accelerating timelines.
11:30 Why Effective Site Regulatory Doc Oversight is the Key to Stress-Free Inspection Readiness
JT Tan, Pharma/CRO Innovation Lead, Complion
At its core, Inspection Readiness is straightforward: everyone's been doing what they should be doing, so there's nothing wrong with taking a look, right? Yet that pit in your stomach tells a different story - why? In this talk, we
will unpack the challenges behind effective regulatory document oversight and introduce a new, pro-active approach to TMF quality through automation.
12:00 pm Transition to Shared Sessions
Neil Weisman, President, Continuum Clinical
12:05 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
Learn how we are creating a connected experience for trial participants before, during and after the trial where patients can access meaningful information, their individual data to share with their EHR, aggregate study results and provide ongoing
feedback and insights to ensure a better experience for patients, caregivers and the site teams. Explore the possibilities to remain connected via communities to raise awareness around trials. The audience can gain insights as to the ins and
outs of how we managed to create a platform to share data directly with patients–from legal, privacy, regulatory and other key stakeholder hurdles to our vision for broadening the scope of data sharing across industry.
12:35 INTERACTIVE PANEL: Translating Virtual to Reality: Decentralized Trial Transformation
Moderator: Jane Myles, Head, Operational Intelligence and Innovation, Roche
Darcy Forman,Vice President, Clinical Operations, Science37
Hassan Kadhim, Director, Clinical Trial Business Capabilities, GCO, Bristol-Myers Squibb
Carrie Melvin, Vice President, Global Clinical Sciences and Delivery TA Head of Oncology, GSK/TESARO
Megan McBride, MPH, Associate Director, Janssen Clinical Innovation, GCDO, R&D, Janssen, The Pharmaceutical Companies of Johnson &
Our expert panel will include a variety of perspectives and the aim is to provide pragmatic solutions and actionable advice to make virtual trials a realistic option for your study needs. We’ll discuss strategic and tactical needs to help
you determine how to navigate and implement virtual and decentralized options to drive your pipeline goals. Topics to be discussed include:
- Discuss the settings for virtual trials and help define best fit options for study needs.
- How and when does the regulatory strategy get set to enable a successful filing?
- What are the challenges to drive both site and patient participation in virtual trials?
- What are the timeline and cost differences in planning for and executing virtual trial components?
- What are the key lessons learned from those who have been early adopters and champions?
1:05 Transition to Lunch
1:10 SCOPE Send Off Luncheon Presentation: Is Your Paper Protocol
Really Fit for Purpose?
Brendan Buckley, MD, DPhil,
Chief Medical Officer, Teckro
When did you last use a telephone directory for a restaurant booking? It might seem absurd to flip through a dated paper directory when the latest information is always searchable online. Why, then, are we still using paper protocols to manage
clinical trials? It’s time we bring clinical trials into the digital era. Join this session to find out how to transform your protocol into actionable data for research staff, study teams and CROs.
1:40 Closing Remarks
1:45 SCOPE Summit 2020 Adjourns