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.

Final Agenda


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

Wednesday, February 20

11:30 am Registration Open (Convention Level)

12:30 pm BRIDGING LUNCHEON PRESENTATION: Metrics, Standards & Technology: How to Harness Digital to Transform Protocol Creation

Brindle_Bob_SSG&SSUBob Brindle, Venture Leader, Life Sciences, Cognizant

How much effort do you waste during clinical trial protocol creation? How do you know? How do you fix it? In this increasingly digital world, it’s frustrating to be constrained by traditional word processing tools, but making the shift to a digital process can be daunting. Join this session to discover the practical steps that will set you up to transform your process – and get a peek at what a digital protocol will enable.

1:10 Coffee and Dessert Break in the Exhibit Hall (Plaza International Ballroom)

2:10 Plenary Keynotes (Regency PQ)

3:20 Booth Crawl & Refreshment Break in the Exhibit Hall, Last Chance for Exhibit Viewing (Plaza International Ballroom)

Orlando N

4:05 Chairperson’s Remarks

John Makowski, Head, Clinical Operations, Audentes Therapeutics

4:10 New EU-Clinical Trials Regulation: Industry Preparation via Pilot Procedures

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

The Regulation (EU) No 536/2014 on clinical trials in medicinal products for human use (EU-CTR), which will apply from 2020, will fundamentally change the procedures for approving and evaluating applications for clinical trials in Europe – e.g. a purely electronic application via an EU portal or a joint assessment between EU-Member State with involvement of national-level authorities and ethics committees. In preparation for the approach introduced by the EU-CTR, different pilot phases have been started in Europe with the aim of fundamentally testing this new process. The presentation will describe the experience of industry and learnings made for the preparation for the new authorization system in Europe.

4:40 Study Start Up Practices and Cycle Times among Sponsors and CROs

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

Tufts CSDD conducted a comprehensive survey among over 400 pharmaceutical and biotechnology companies and contract research organizations examining the processes of site identification, site selection and study start up. The survey examined site selection practices and decision-making, study start up timelines, and site feasibility, and also explored the implementation of specific tools and resources that impact cycle time, cost, and performance. Tufts also assessed those factors contributing to poor site selection; and improvements made to the site selection and start up processes. Key performance metrics (e.g. cycle time) were gathered for site selection, site identification and study start up activities, and comparisons were made between those companies using new vs. repeat sites, sponsors and CROs, and those companies with varying investment levels in technology.

5:10 Disassembling Endemic Silos in Pharma Pivotal to Improving the Clinical Trial Continuum

Chung_Jae_SSUJae Chung, President & Founder, goBalto

Workflow-based technology coupled with executive authoritative power encourages process optimization in the clinical trial continuum, helping to break down silos, enhance operational performance and ensure quality in the electronic trial master file.

5:25 EnForeSys – A Simulation Tool for Enrollment Planning

Kulkarni_HrishikeshHrishikesh Kulkarni, Principal Statistician, QA and Pre-Sales Support, Cytel

A majority of clinical trials experience delays in enrollment, which can lead to discontinuation and loss of revenue. EnForeSys, a sophisticated tool for enrollment planning, makes this task more manageable. In this talk, we will explore useful options to incorporate a trial planner’s experience into a simulation based approach.

5:40 CASE STUDY: The Sites First Initiative: Understanding Patients and Site Relationships to Improve Trials

Rackley_MarisaMarisa Rackley, Director, Clinical Development Execution, Vertex Pharmaceuticals

This presentation will share Vertex’s site-focused initiatives and our journey to put sites first. How did the initiative start? What were the obstacles? In addition to describing the other parts of the initiative, the talk will focus on the installation of our new Regional Site Advocate group and share data from the sites on how this role has helped to bring value to the sites.


DrFirst 6:107:10 Networking Reception (Regency Foyer)


Thursday, February 21

7:15 am Registration Open (Convention Level)

Medidata 7:45 BREAKFAST PRESENTATION: A User's Perspective into a Unified Imaging and EDC Approach (Regency P)

Troy SchneiderTroy Schneider, Director, Imaging Strategy, Medidata

Halek_SarahSarah Halek, Head, Innovation Design, ICON Medical Imaging

Come hear from a client on how using an imaging management technology on a unified platform considers the entire clinical trial process, providing configurable, intelligent workflows that complements the users and aligns to protocols, automating de-identification, edit checks, and workflow management, thereby reducing clinical trial timeline, cost, and risk. The platform ensures that correct data is presented to the right users at the right time, eliminating data reconciliation tasks and bringing visibility and access.

8:15 Session Break

Orlando N 

8:20 Chairperson’s Remarks

Chris Crucitti, Chief Commercial Officer, CRF Bracket

8:25 Re-Defining the Site Investigator Experience

Moneymaker_LisaLisa Moneymaker, CTMS Process Architect, Amgen

Imagine a world where Site Investigators could use a centralized point of access for all study-related tasks and study information, rather than many portals and platforms, to access studies with every Sponsor they work with. Imagine if Sponsors could quickly search for and download their latest study documents, and easily access a registry of Investigator profiles to assess feasibility for new studies. The Shared Investigator Platform (SIP) was launched with these goals in mind and continues to evolve with new functionality. This session will provide real-world observations and learnings from the SIP’s first major wave of adoption.

8:45 Site Management Approaches in Gene Therapy & Rare Disease Clinical Trials: A Collaborative Approach to be a Sponsor of Choice

Makowski_JohnJohn Makowski, Head, Clinical Operations, Audentes Therapeutics

There is significant complexity, sensitivity and timely logistics to most effectively execute gene therapy, rare disease clinical trials. The importance of a Clinical Operations organization to have a well-established collaborative approach with Investigators, Internal Medical Science Liaisons and Advocacy Groups is key to successful execution of these complex studies. The ability to simplify and innovate around a sponsor’s Site Management approaches can increase your ability to be a sponsor of choice in this competitive and exciting area of drug development. We will review several different approaches and strategies to consider to position a team for success in this space.

9:05 Transforming Informed Consent: Current Landscape and Tools to Enable the Future of eConsent

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

While the shift to digital technologies is pervasive across multiple industries, the informed consent process for clinical trials remains primarily paper-based. Further, the increasing complexity in clinical trial-informed consent language and longer paper consent forms are increasing the importance of efforts to enhance patient comprehension, which may in turn contribute to increased study compliance, and fewer withdrawals from a study. TransCelerate’s eConsent initiative stands to transform the informed consent process by using an array of patient-focused, multi-media components to improve understanding of a study and create process efficiencies for sites and sponsors. This session will share how the initiative has created the first cross-industry perspective, developed over a period of 2 years with input from over 14 global pharmaceutical companies.

9:25 Improving Site-Study Activation and Study Timelines through Harmonizing Budgeting, Contracts, Data, and Payments

Farmer_TrentonTrent Farmer, Contract Manager, Attorney, CSL Behring

Site activation timelines and site payments both remain key industry issues. Simplifying and streamlining processes provides benefits for both sites and sponsors. This session covers how approaching the budgeting and contracting phases with both data and payments in mind can improve site activation timelines while creating a better foundation for prompt, accurate, and timely site payments.

9:55 AI Augmentation of Site Selection and Patient Prescreening

Galil_KarimKarim Galil, PhD, CEO & Co-Founder, Mendel Health

Healthcare professionals collectively bemoan the inefficiencies endemic to standard pretrial practices, but divide on to what extent AI can assist them. Dr. Karim Galil maintains that AI will be an integral part of future pretrial practices and supports his claim with recent findings from a first-of-its-kind study comparing AI-augmented patient prescreening to standard practices.

10:25 Networking Coffee Break (Sponsorship Opportunity Available) (Regency Foyer)

Orlando N

11:10 Chairperson’s Remarks

Chris Crucitti, Chief Commercial Officer, CRF Bracket

11:15 CASE STUDY: GSK’s Journey of Launching a Formal Study Start-Up Department

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

In mid-2018, GSK established a Study Start Up Department bringing together core functions: Clinical Planning, Investigator Contracts & Benchmarking, Technology & Innovation and Study Start-up Leads. This Case Study will provide insight to our vision, capabilities and delivery methodology of providing subject matter expertise to enable quicker and more efficient study start-ups in a complex, global environment.

11:45 Transforming Study Start-Up

Davidson_AshleyAshley Davidson, Director, Vault Study Startup, Strategy, Veeva

The industry sees tremendous opportunity to simplify and streamline study start-up processes. In a recent survey, 83% of respondents said their organizations have an initiative underway to do so. Join Veeva to learn how a unified clinical operating model eliminates costly study start-up delays and speeds execution. Explore what other organizations are doing to streamline study start-up processes from site identification to site activation. Identify and quantify the value of improvements for your organization.

12:15 pm Transition to Shared Sessions

Regency P

Chairperson’s Remarks

Kyle Hogan, Director, eClinical Solutions, Clinical Ink

12:20 Focus on the Worst? A Weak-link Approach to Improving Site Performance and Accelerating Clinical Trials

Hopkins_AngeliqueAngelique 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 depends 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.

12:50 INTERACTIVE PANEL: Moving from Technology Indigestion to Workable Solutions

Vulcano_DavidModerator: David Vulcano, MBA, Vice President, Research Compliance & Development, HCA

Abbott_StephanieStephanie Abbott, PharmD, Clinical Research Program Director, Western Washington Medical Group

Yanak_BrendaBrenda Yanak, Former Global Head, Specimen Strategy and Innovation, Q2 Solutions a Quintiles Quest Joint Venture; Former Precision Medicine Lead, Pfizer

Moyer_MattMatt Moyer, MBA, Director, Clinical Supply Technology, Merck

Multiple technologies are advancing healthcare delivery each and every day. This not only pertains to better utilizing both data at rest and data in motion, but also pertains to communication technologies breaking down the traditional boundaries of medicine. As clinical trial site operations are often dwarfed by the larger healthcare delivery ecosystem, how can pharma leverage that already-developing ecosystem so that they don’t have to recreate the wheel?

  • What technologies are out there right now that are underutilized by pharma in clinical trials?
  • What regulatory or operational issues need to be either “myth busted” or challenged to make this happen?

1:20 Transition to Lunch


1:25 LUNCHEON PRESENTATION: The Secret to Unlock Adoption of eClinical Solutions

Lee_JeffJeff Lee, President, eCOA & Patient Engagement, CRF Bracket

Technologies such as eConsent and ePRO are well-known by many researchers and have many case studies demonstrating their value. And yet, they are still used by a minority of studies. Why is this? This session will explore some hidden opportunities that lead to higher adoption of eClinical technologies. This session includes an open discussion format, so please bring all your thoughts and concerns on this topic!

1:55 Closing Remarks

2:00 SCOPE Summit 2019 Adjourns

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

video recap

SCOPE 2019 is dedicated to the life and memory

Christine K. Pierre
September 8, 1958 - October 23, 2018

Read More…

“SCOPE Featured Author”
Emmanuel Fombu, MD, MBA
Global Commercial Strategy and
Digital Innovation, Johnson & Johnson

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Mendel Health

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