SSU_Header

Improving Site-Study Activation and Performance


Clinical trial site activation and efficient study start up are critical to drug development programs, in terms of time, cost and quality of data. In order 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. Cambridge Healthtech Institute’s Third Annual “Improving Site-Study Activation and Performance” conference will cover the topics one should consider when strategically implementing a process for rapid study start-up.

Arrive early and attend Part 1: Global Site Selection
Keynotes | Monday Short Courses | Speaker Biographies

Wednesday, February 24 - Thursday, February 25

BRIDGING LUNCHEON PRESENTATION


AFTERNOON PLENARY KEYNOTES
ADVANCING CLINICAL RESEARCH WITH TECHNOLOGY AND INNOVATION  

CLN Best Practices

Plenary Keynote Chairperson’s Opening Remarks & Clinical Informatics News Best Practices Awards

Allison Proffitt, Editorial Director, Bio-IT World & Clinical Informatics News


Innovation, Technology and the Hype Cycle: What Is Real and Adaptable and What Is Not?

Craig Lipset, Head, Clinical Innovation, Pfizer

Adoption Of Technology Solutions In Clinical Trials: Are We Ready?

Margaretta Nyilas, M.D., Senior Vice President, Clinical & Business Operations, OTSUKA Pharmaceutical Development & Commercialization, Inc.


For more details on the Tuesday Opening Plenary Keynote and Wednesday Afternoon Plenary Keynote click here.


SITE-SPONSOR COLLABORATION AND DEEP TEAM INTEGRATION TO ACHIEVE SUCCESSFUL STUDY LAUNCH

Chairperson’s Remarks

Silvana Giustino, Vice President, Clinical Affairs, Amneal Pharmaceuticals

CO-PRESENTATION: The Social Experiment: Deep Team Integration with Sites and Providers Results in a Successful Study Launch

Deirdre BeVard, Vice President, Development Operations, Nektar Therapeutics
Eileen Daniel, Executive Director, Clinical Operations, Nektar Therapeutics

VeevaIntegrating TMF and Clinical Processes to Improve Study Operations

Kathryn King, Ph.D., Vice President, Vault Clinical, Veeva Systems

CO-PRESENTATION CASE STUDY: C-Diff Recruitment Challenges and How We Put the Brown in Jean Brown Research!: Site and Sponsor Collaboration to Achieve Success

Janet Christoff, Clinical Trial Manager, Study Management and Logistics, Sanofi Pasteur
Carol Minoughan, Vaccine Project Manager, Jean Brown Research

Mitigating Clinical Trial Risk and Operational Cycle Times through Cloud Based Workflow Technologies

Barry Milton, Director, Pre-Sales, goBalto, Inc.


SIMPLIFYING RESEARCH AND IMPROVING QUALITY: OPTIMIZING THE SITE EXPERIENCE TO BENEIFT PATIENTS, SITES AND SPONSORS

Chairperson’s Remarks

Speaker to be Determined

Optimizing the Site Experience in the Era of Patient-Centric Trials

Carol Seider, Sr. Director, Global Clinical Operations, Biogen

CASE STUDY: CTA Adoption: Collaboration to Simplify Research and Processes to Benefit Sponsors, Sites and Patients

Dex Bilkic, MBA, Leader, Business Support Group, Boehringer Ingelheim

CO-PRESENTATION: Creating a Culture of Quality in your Organization: New Ideas for Compliance Management

Deborah Guattery, Quality Systems, CAPA Manager, Clinical Quality Control and Compliance, CSL Behring

Sheri Kuss, Quality and Compliance Manager, Clinical Quality Control & Compliance, Clinical Operations, CSL Behring


INTEGRATING PATIENT INSIGHTS AND DATA ANALYTICS TO IMPROVE TRIAL PLANNING, CLIN OPS, INVESTIGATOR RETENTION AND PATIENT ENGAGEMENT
Special Shared Session

Chairperson’s Remarks

Speaker to be Determined

Implementing True Patient Centricity: How Understanding the Mission and the Burden on Patients Will Improve Trials

Christine Pierre, Founder and President, Society for Clinical Research Sites (SCRS)

CO-PRESENTATION: Integrating Data Science into Clinical Trial Planning and Operations

Debbie Profit, Ph.D., Director, Corporate Projects, Otsuka Pharmaceuticals Development and Commercialization

Shashank Rohatagi, Ph.D., Senior Director, Translational Medicine and Think Team, Otsuka Pharmaceuticals Development and Commercialization

CO-PRESENTATION: Implementing a Patient Centricity Platform to Better Engage Patients and Sites in Informed Consent Process

Jane Fang, Ph.D., Director, R&D IS Lead, Clinical Business Management & Analytics, AZ/MedImmune

Robert Allen, Senior Director, Digital Innovation Group, AstraZeneca

INTERACTIVE PANEL: Can We Shift Investigators from "1 and Done" to Repeat Performers?

Claire Sears, Ph.D., Director, Investigator Engagement, SiteStart, DrugDev

Kenneth Getz, MBA, Director, Sponsored Research Programs, Tufts CSDD; Chairman, CISCRP

Christine Pierre, Founder and President, Society for Clinical Research Sites (SCRS)

 

Arrive early and attend Part 1: Global Site Selection
Keynotes | Monday Short Courses | Speaker Biographies


Click on Image

SCOPE 2015 Wrap-Up

Held February 24-26, 2015, in Orlando, Florida, the 6th Annual SCOPE Summit gathered more than 900 industry leaders, an attendance increase of 30% from 2014, for three stimulating days of in-depth discussions covering important issues in clinical trial planning and management. With 12 different conference tracks, a Clinical Informatics News Best Practices Awards and three plenary keynote sessions, SCOPE offered advances and innovative solutions in all aspects of clinical trial management and operations, including Data Integration, Feasibility, Site Selection and Management, Patient Engagement, Recruitment and Retention, Mobile Tech, Project Management, Forecasting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Post-Marketing Studies, and Pharmacovigilance. The impressive executive audience at SCOPE came together for invaluable networking opportunities with more than 70% of the attendees titled as Executives from leading Pharma (24%), CRO (31%), and Biotech companies (20%). Industry leaders and key decision makers representing 13 different countries and more than 360 unique organizations shared case studies, collaborated on best practices and provided unique perspectives on poignant issues that the field currently faces.

For Further Information

For questions or suggestions about the meeting, please contact:

Micah Lieberman
Executive Director, Conferences
Cambridge Healthtech Institute (CHI)
T: (+1) 541.482.4709
E: mlieberman@healthtech.com

For partnering and sponsorship information, please contact:

Ilana Quigley
Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5457
E: iquigley@healthtech.com

For media and association partnerships, please contact:

Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456
E: rhandy@healthtech.com

Japan-Flag Korea-Flag China-Simplified-Flag China-Traditional-Flag  



Preliminary Agenda Available!


  Scope CAG 2016

 

> Premier Sponsors

 BBK

 ClinicalInk

Drug Dev

 IMS Health  

PRA Health Sciences

QUINTILES

> View All Sponsors

> View Media Partners

> View Attendee List

> Attendee Profile