Rethinking Clinical Trials

Grand Rounds November 6: Appendectomy vs Antibiotics for Appendicitis-Early Results from the CODA trial
2020-11-06 13:00 - 14:00 (America/New_York)
Speaker:

David R. Flum, MD, MPH
Professor, Surgery, Health Services, and Pharmacy
Associate Chair for Research, Department of Surgery
University of Washington
Topic: Appendectomy vs Antibiotics for Appendicitis-Early Results from the CODA trial
Date: Friday, November 6, 2020, 1:00-2:00 p.m. ET
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Grand Rounds October 30: Lessons from Virtual Trials in Time of a Pandemic: Minnesota Hydroxychloroquine Experience
2020-10-30 13:00 - 14:00
Speaker:

David R. Boulware MD, MPH
Professor of Medicine
Infectious Disease & International Medicine
Department of Medicine
University of Minnesota
Topic: Lessons from Virtual Trials in Time of a Pandemic: Minnesota Hydroxychloroquine Experience
Date: Friday, October 30, 2020, 1:00-2:00 p.m. ET
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October 27-30: Simplifying Informed Consent - OHRP Virtual Workshop at the NIH Office of Extramural Research Fall Regional Seminar
2020-10-27 08:00 - 2020-10-30 17:00
The NIH Office of Extramural Research (OER) will host its semi-annual regional seminar virtually this fall from October 27-30. Registration is required, and the event is free.
Mark your calendars to join OHRP on Friday, October 30, 1:00-2:45pm EDT for an extended session about informed consent, including practical tips on integrating the revised Common Rule requirements into your consenting processes.
And don’t miss a special Q&A with OHRP session on Tuesday, October 27, 3:00-4:00pm. Once registered for the regional seminar, find the link to attend the Q&A session under the NIH Human Subjects, Clinical Trials, and Inclusion Booth Events.
Registration and more information as is it available at: nihvirtualseminar2020.vfairs.com/

Grand Rounds October 23: Outpatient Clinical Decision Support - An Evidence-Based Implementation Framework
2020-10-23 13:00 - 14:00
Speakers:

Patrick O’Connor, MD, MA, MPH
Senior Clinical Investigator
HealthPartners Institute
JoAnn Sperl-Hillen, MD
Senior Clinical Investigator
HealthPartners Institute
Topic: Outpatient Clinical Decision Support – An Evidence Based Implementation Framework
Date: Friday, October 23, 2020, 1:00-2:00 p.m. ET
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Grand Rounds October 16: Back to School, It’s More Than Just a Trip to Target This Year: The ABC Science Collaborative
2020-10-16 13:00 - 14:00
Speakers:

Danny Benjamin, MD, PhD
Kiser-Arena Distinguished Professor of Pediatrics, Duke University
Chair, Pediatric Trials Network
Deputy Director, Duke Clinical Research Institute
Topic: Back to School, It’s More Than Just a Trip to Target This Year: The ABC Science Collaborative
Date: Friday, October 16, 2020, 1:00-2:00 p.m. ET
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October 15, 2020: NIA IMPACT Collaboratory Grand Rounds: The AHRQ and Lancet Reports on Dementia Interventions: Interpretation and Implications for Embedded Pragmatic Trials
2020-10-15 12:00 - 13:00
Presenters:
Joe Gaugler, PhD
Robert L. Kane Endowed Chair in Long-Term Care and Aging
Professor, University of Minnesota
Associate Core Leader, IMPACT Implementation Core
Eric Larson, MD, MPH
Vice President, Research and Health Care Innovation
Kaiser Foundation Health Plan of Washington
Executive Director and Senior Investigator
Kaiser Washington Health Research Institute
Core Leader, IMPACT Health Care Systems Core
Lisbeth Nielsen, PhD
Director, Division of Behavioral and Social Research
National Institute on Aging
Zoom Details:
Please click the link below to join the webinar:
https://hebrewseniorlife.zoom.us/j/97344810673
Webinar ID: 973 4481 0673
International numbers available: https://hebrewseniorlife.zoom.us/u/ac4bYFtynq

Grand Rounds October 9: Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo)
2020-10-09 13:00 - 14:00
Speaker:

Myles Wolf, MD, MMSc
Division of Nephrology, Department of Medicine
Duke Clinical Research Institute
Duke University School of Medicine
Topic: Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo)
Date: Friday, October 9, 2020, 1:00-2:00 p.m. ET
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Grand Rounds October 2: Driving Toward Health Impact: Our Journey and Path Forward
2020-10-02 13:00 - 14:00
Speaker:

Nakela L. Cook, MD, MPH
Executive Director
PCORI
Topic: Driving Toward Health Impact: Our Journey and Path Forward
Date: Friday, October 2, 2020, 1:00-2:00 p.m. ET
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Grand Rounds September 25: Accelerating the Nation’s COVID-19 Testing Capacity: An Update from the NIH’s RADx Program
2020-09-25 13:00 - 14:00
Speakers:

Rick Bright, PhD
Senior Advisor to the NIH Director
Rachael Fleurence, PhD
Special Assistant to the NIH Director for COVID-19 Diagnostics
Topic: Accelerating the Nation’s COVID-19 Testing Capacity: An Update from the NIH’s RADx Program
Date: Friday, September 25, 2020, 1:00-2:00 p.m. ET
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Grand Rounds September 18: The Trauma Survivors Outcomes and Support (TSOS) Pragmatic Clinical Trial: Effectiveness and Implementation Process Assessment Results
2020-09-18 13:00 - 14:00
Speaker:

Douglas Zatzick, MD
Professor of Psychiatry and Behavioral Sciences
Harborview Medical Center, University of Washington School of Medicine
Topic: The Trauma Survivors Outcomes and Support (TSOS) Pragmatic Clinical Trial: Effectiveness and Implementation Process Assessment Results
Date: Friday, September 18, 2020, 1:00-2:00 p.m. ET
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September 17, 2020: NIA IMPACT Grand Rounds: Not All Approaches to Data Are Created Equal: Data-related Challenges for Pragmatic Trials Involving Patients Living With Dementia
2020-09-17 12:00 - 13:00
Presenters:
David Dorr, MD, MS
Professor & Vice-Chair of Medical Informatics and Clinical Epidemiology
Professor of Medicine, Division of General Internal Medicine and Geriatrics
Chief Research Information Officer, Biomedical Informatics Graduate Program
Oregon Health and Science University School of Medicine
V.G. Vinod Vydiswaran, PhD
Assistant Professor of Learning Health Systems
Assistant Professor of Information
University of Michigan
Zoom details:
Please click the link below to join the webinar:
https://hebrewseniorlife.zoom.us/j/97344810673
Registration is not required, and we will have a recording of the webinar as well as a companion podcast available after the event on our website, impactcollaboratory.org

September 16-17: PCORI 2020 Virtual Annual Meeting - Accelerating Impact on Care and Patient-Centered Outcomes
2020-09-16 - 2020-09-17
Registration is now open for PCORI’s sixth Annual Meeting, Accelerating Impact on Care and Patient-Centered Outcomes, being held virtually September 16-17. Join this FREE event celebrating PCORI’s 10-year anniversary and discuss how to answer the research questions of the future.
The meeting will highlight results from several PCORI-funded studies and explore how we can shorten the time from research to improved health for patients. During the meeting, attendees will:

Learn about our efforts to disseminate research findings
Network with others
Examine PCORI’s emphasis on engagement
Explore participation in developing our research agenda
Listen to powerful, inspiring keynote speakers

REGISTER NOW for one session or the entire meeting.
For more information, visit the PCORI Virtual Annual Meeting website and follow #PCORI2020.

Grand Rounds September 11: Launching CONNECTS: Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies
2020-09-11 13:00 - 14:00
Speakers:

Gordon R. Bernard, MD
CONNECTS ACC Science Unit P
Professor of Medicine
Executive Vice President for Research
Senior Associate Dean for Clinical Science
Vanderbilt University Medical Center
Sonia Thomas, DrPH
CONNECTS ACC Principal Investigator
Senior Research Statistician
RTI International
Topic: Launching CONNECTS (Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies): A Partnership Between Research Triangle Institute, Vanderbilt University Medical Center, and the NHLBI
Date: Friday, September 11, 2020, 1:00-2:00 p.m. ET
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Grand Rounds September 4: No Presentation (Labor Day Holiday)
2020-09-04 13:00 - 14:00

Grand Rounds August 28: Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Clinical Trials: Proceedings from a Multi-Stakeholder Think Tank Meeting
2020-08-28 13:00 - 14:00
Speakers:

Lesley Curtis, PhD
Chair and Professor, Department of Population Health Sciences
Duke University School of Medicine
Trevor Lentz, PT, PhD, MHA
Assistant Professor in Orthopaedic Surgery
Duke Clinical Research Institute
Frank Rockhold, PhD, ScM, FASA, FSCT
Professor of Biostatistics and Bioinformatics
Duke Clinical Research Institute
Topic: Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Clinical Trials: Proceedings from a Multi-Stakeholder Think Tank Meeting
Date: Friday, August 28, 2020, 1:00-2:00 p.m. ET
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Grand Rounds August 21: Adaptive Platform Trials: Scalable from Breast Cancer to COVID
2020-08-21 13:00 - 14:00
Speaker:

Laura Esserman, MD, MBA
Director, UCSF Carol Franc Buck Breast Care Center
Alfred A. de Lorimier Endowed Chair in General Surgery
Professor of Surgery and Radiology, UCSF
Topic: Adaptive Platform Trials: Scalable from Breast Cancer to COVID
Date: Friday, August 21, 2020, 1:00-2:00 p.m. ET
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Grand Rounds August 14: Learning While Sprinting: A One-Year Retrospective from the NOHARM Pragmatic Trial
2020-08-14 13:00 - 14:00
Speakers:

Jon Tilburt, MD
Professor of Medicine and Biomedical Ethics
Mayo Clinic
Andrea Cheville, MD
Professor of Physical Medicine and Rehabilitation
Mayo Clinic
Topic: Learning While Sprinting: A One-Year Retrospective from the NOHARM Pragmatic Trial
Date: Friday, August 14, 2020, 1:00-2:00 p.m. ET
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August 11-12, 2020: Colorado Pragmatic Research in Health 2020 Virtual Conference
2020-08-11 - 2020-08-12
The Colorado Pragmatic Research in Health (COPRH) announces its inaugural conference, offering more than 26 hours of presentations with real-time Q&A and focused discussions about methods, models, and measures for planning pragmatic research. Designed for clinical and translational investigators, including statisticians, dissemination and implementation scientists, health services and public health researchers, and program evaluators, COPRH Con sessions incorporate pragmatic trial planning using PRECIS-2, pragmatic research approaches and study design, rapid qualitative and mixed methods, and stakeholder engagement.
Date: August 11-12
For details and registration, visit http://coprhcon.com/Register/

Grand Rounds August 7: The Democratization of Medicine: Open Access, Social Media, AI, Apps, and Empowering the Patient as the Future of Clinical Research
2020-08-07 13:00 - 14:00
Speaker:

C. Michael Gibson, MS, MD
Professor of Medicine
Harvard Medical School
President and CEO
Baim and PERFUSE Research Institutes
Topic: The Democratization of Medicine: Open Access, Social Media, AI, Apps, and Empowering the Patient as the Future of Clinical Research
Date: Friday, August 7, 2020, 1:00-2:00 p.m. ET
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July 31, 2020: NIA IMPACT Collaboratory to Present at Alzheimer's Association International Conference
2020-07-31 14:00 - 16:00
The IMPACT Collaboratory will have a strong presence at the upcoming Alzheimer’s Association International Conference (AAIC). NIA IMPACT Embedded Pragmatic Clinical Trials (ePCTs) for the Improvement of Care for People Living with Dementia (PLWD) and their Care Partners features IMPACT members: Vince Mor, PhD, Laura Hanson, MD, MPH, Jason Karlawish, MD, and Fan Li, PhD, presenting key considerations in the design and conduct of embedded PCTs for PLWD.
Virtual modules July 27-July 31. Live panel session July 31 at 2pm EST. Learn more about the live panel session. Registration is free at alz.org/aaic. AAIC will provide instructions on how to join the live panel through their platform closer to the date of the event.
Pre-recorded materials will become available on-demand beginning Monday, July 27. A live session will be held on Friday, July 31. All pre-recorded content will be available for 30 days after the conference.

Grand Rounds July 31: Using Real-World Data to Plan Eligibility Criteria and Enhance Recruitment: Actionable Recommendations and Resources from the Clinical Trials Transformation Initiative
2020-07-31 13:00 - 14:00
Speakers:

Sudha Raman, PhD, MA
Assistant Professor
Department of Population Health Sciences
Duke University
John Sheehan, PhD, MBA, RPh
Senior Director, Value and Evidence (HEOR) Neuroscience
Janssen Scientific Affairs, LLC
Topic: Using Real-World Data to Plan Eligibility Criteria and Enhance Recruitment: Actionable Recommendations and Resources from the Clinical Trials Transformation Initiative
Date: Friday, July 31, 2020, 1:00-2:00 p.m. ET
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Grand Rounds July 24: TENS in Fibromyalgia: From Fundamental Neurobiology to Pragmatic Trial
2020-07-24 13:00 - 14:00
Speaker:

Leslie J. Crofford, MD
Wilson Family Chair and Professor of Medicine
Vanderbilt University Medical Center
Topic: TENS in Fibromyalgia: From Fundamental Neurobiology to Pragmatic Trial
Date: Friday, July 24, 2020, 1:00-2:00 p.m. ET
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Living Textbook Grand Rounds Series July 17: Part 5-Choosing What to Measure and Making it Happen: Your Keys to Pragmatic Trial Success
2020-07-17 13:00 - 14:00
Speakers:
Rachel Richesson, PhD, MPH
Associate Professor, Informatics
Duke University School of Nursing
Devon Check, PhD
Assistant Professor, Population Health Sciences
Department of Population Health
Topic: Part 5-Choosing What to Measure and Making it Happen: Your Keys to Pragmatic Trial Success
Date: Friday, July 17, 2020, 1:00-2:00 p.m. ET
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Access code: 730 486 227
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IMPACT Collaboratory Grand Rounds July 16: Breaking the Cycle: Health Care Systems Interactions for Impactful Results
2020-07-16 12:00 - 13:00
Speakers:
Leah Hanson, PhD
Senior Research Investigator, Senior Director of Research at HealthPartners Neuroscience Center, Health Partners Institute
Co-Director of Research, HealthPartners Center for Memory and Aging
Eric Larson, MD, MPH
Vice President, Research and Health Care Innovation, Kaiser Foundation Health Plan of Washington
Executive Director and Senior Investigator, Kaiser Washington Health Research Institute
David Reuben, MD
Archstone Professor of Medicine, Director UCLA Multicampus Program in Geriatric Medicine and Gerontology,
David Geffen School of Medicine at UCLA
Jeff Williamson, MD, MHS
Professor, Chief of Geriatric Medicine, and Director for Center for Healthcare Innovation, Wake Forest School of Medicine
Topic: Breaking the Cycle: Health Care Systems Interactions for Impactful Results
Date: Thursday, July 16, 2020, 12:00-1:00 p.m. ET
To join the online meeting:
Go to: https://hebrewseniorlife.zoom.us/j/97344810673
Dial-In: +1 312 626 6799 or +1 470 250 9358 or +1 470 381 2552 or +1 646 518 9805
Meeting ID: 973 4481 0673

Methods: Mind the Gap Webinar July 14: Overview of Statistical Models for the Design and Analysis of Stepped Wedge Cluster Randomized Trials
2020-07-14 13:00 - 14:00 | https://dukemed.webex.com/dukemed/j.php?MTID=m4c6e3e4827442a92338a5649cee613e6
Speaker:
Fan Li, PhD
Yale University School of Public Health
Description:
The stepped-wedge cluster randomized design has received increasing attention in pragmatic clinical trials (PCTs) and implementation science research. Since the design’s introduction, a variety of mixed-effects model extensions have been proposed for the design and analysis of PCTs. In this talk, Dr. Fan Li of Yale University will provide a general model representation and regard various model extensions as alternative ways to characterize secular trends, intervention effects, and sources of heterogeneity. He will also review key model ingredients and clarify their implications for the design and analysis of stepped-wedge trials.
Registration required:
https://www.prevention.nih.gov/education-training/methods-mind-gap/overview-statistical-models-design-and-analysis-stepped-wedge-cluster-randomized-trials

Grand Rounds July 10: COVID Open Science Collaborative Analytics Platform: National COVID Cohort Collaborative (N3C)
2020-07-10 13:00 - 14:00
Speakers:

Ken Gersing, MD
Director of Informatics, NCATS
National Institutes of Health
Robert A. Star, MD
Director, Division of Kidney, Urologic, and Hematologic Disorders, NIDDK
Chief, Renal Diagnostics and Therapeutics Unit, NIDDK
National Institutes of Health
Topic: COVID Open Science Collaborative Analytics Platform: National COVID Cohort Collaborative (N3C)
Date: Friday, July 10, 2020, 1:00-2:00 p.m. ET
Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php.
To join the online meeting:
Go to https://dukemed.webex.com/dukemed/j.php?MTID=m7516d59dab184670d6fc892b1955b4eb
You must log in to the URL first.
Click ‘Audio Conference’
Choose ‘I will call in’, select the Toll number.
Dial in using the information from the dialog box that appears.
Be certain to use the Access Code AND the Attendee ID.
Troubleshooting:
If the URL above does not work, go to dukemed.webex.com and enter:
Meeting Number: 730 486 227
Meeting Password: [REDACTED]
For Audio ONLY:
Call-in toll number (US/Canada): 1-650-479-3207
Access code: 730 486 227
NOTE: For Toll-free users, the call-back (call me) services are also available.

Grand Rounds July 3: No Presentation (Independence Day Holiday)
2020-07-03 13:00 - 14:00

Grand Rounds EHR Workshop Series June 26: Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Keys to Success in the Evolving EHR Environment
2020-06-26 13:00 - 14:00
Speakers:

Guest Moderator
Keith Marsolo, PhD
Associate Professor, Population Health Sciences
Duke University
Panel
Teresa Zayas-Cabán, PhD
Chief Scientist
Office of the National Coordinator for Health Information Technology
Office of the Secretary, DHHS
George (Holt) Oliver, MD, PhD
Vice President Clinical Informatics
Parkland Center for Clinical Innovations
Christopher A. Longhurst, MD, MS
CIO and Associate CMO, Quality/Safety
Professor of Pediatrics and Medicine
UC San Diego Health
Rachel Richesson, PhD, MPH
Associate Professor
Duke University School of Nursing
Topic: Advances at the Intersection of Digital Health, Electronic Health Records and Pragmatic Clinical Trials: Keys to Success in the Evolving EHR Environment
Date: Friday, June 26, 2020, 1:00-2:00 p.m. ET
Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php.
To join the online meeting:
Go to https://dukemed.webex.com/dukemed/j.php?MTID=m7516d59dab184670d6fc892b1955b4eb
You must log in to the URL first.
Click ‘Audio Conference’
Choose ‘I will call in’, select the Toll number.
Dial in using the information from the dialog box that appears.
Be certain to use the Access Code AND the Attendee ID.
Troubleshooting:
If the URL above does not work, go to dukemed.webex.com and enter:
Meeting Number: 730 486 227
Meeting Password: [REDACTED]
For Audio ONLY:
Call-in toll number (US/Canada): 1-650-479-3207
Access code: 730 486 227
NOTE: For Toll-free users, the call-back (call me) services are also available.

Living Textbook Grand Rounds Series June 19: Part 4-Demystifying Biostatistical Concepts for Embedded Pragmatic Clinical Trials
2020-06-19 13:00 - 14:00
Speakers:

Elizabeth Turner, PhD
Associate Professor
Department of Biostatistics & Bioinformatics and Duke Global Health Institute
Duke University
Patrick Heagerty, PhD
Professor
Department of Biostatistics
University of Washington
David Murray, PhD
Associate Director for Prevention
Director, Office of Disease Prevention
National Institutes of Health
Topic: Part 4-Demystifying Biostatistical Concepts for Embedded Pragmatic Clinical Trials
Date: Friday, June 19, 2020, 1:00-2:00 p.m. ET
Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php.
To join the online meeting:
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Click ‘Audio Conference’
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Dial in using the information from the dialog box that appears.
Be certain to use the Access Code AND the Attendee ID.
Troubleshooting:
If the URL above does not work, go to dukemed.webex.com and enter:
Meeting Number: 730 486 227
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Call-in toll number (US/Canada): 1-650-479-3207
Access code: 730 486 227
NOTE: For Toll-free users, the call-back (call me) services are also available.

Grand Rounds June 12: A Cluster Randomized Pragmatic Trial of an Advance Care Planning Video Intervention in Long-Stay Nursing Home Residents: Main Findings from the PROVEN Trial
2020-06-12 13:00 - 14:00
Speaker:

Susan L. Mitchell MD, MPH
Senior Scientist
Hebrew SeniorLife
Hinda and Arthur Marcus Institute for Aging Research
Professor of Medicine
Harvard Medical School
Topic: A Cluster Randomized Pragmatic Trial of an Advance Care Planning Video Intervention in Long-Stay Nursing Home Residents: Main Findings from the PROVEN Trial
Date: Friday, June 12, 2020, 1:00-2:00 p.m. ET
Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php.
To join the online meeting:
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Click ‘Audio Conference’
Choose ‘I will call in’, select the Toll number.
Dial in using the information from the dialog box that appears.
Be certain to use the Access Code AND the Attendee ID.
Troubleshooting:
If the URL above does not work, go to dukemed.webex.com and enter:
Meeting Number: 730 486 227
Meeting Password: [REDACTED]
For Audio ONLY:
Call-in toll number (US/Canada): 1-650-479-3207
Access code: 730 486 227
NOTE: For Toll-free users, the call-back (call me) services are also available.
