en-USen-GB
  • Virtual Global Workshop 11-13 May 2020
    Virtual Global Workshop 11-13 May 2020
  • Tokyo 2-3 December 2019
    Tokyo 2-3 December 2019
  • Zurich 28-30 October 2019
    Zurich 28-30 October 2019
  • Peapack 14-16 October 2019
    Peapack 14-16 October 2019
  • Brussels 15-17 May 2019
    Brussels 15-17 May 2019
  • Danbury 8-10 April 2019
    Danbury 8-10 April 2019

WHO WE ARE

The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.


News from the eCF

Login to also view news for Members.

Electronic Data Capture

Free Public Webinar: Sponsor responsibility to Assess Investigator Site Systems that may originate source for clinical trials & the free eSRA tool
  • 1459
  • Article rating: 5.0

Free Public Webinar: Sponsor responsibility to Assess Investigator Site Systems that may originate source for clinical trials & the free eSRA tool

Offered 2 times on either Feb 25 or Feb 26 2020

Presenter:  Kelley Olree, Study Manager – Pfizer, and eClinical Forum eSRA Team

This webinar will discuss:

  • What the Sponsor’s responsibility is regarding using data that has originated in an Investigator Site system (Electronic Health Records (EHR) or Electronic Medical Records (EMR) according to different health authorities
  • Benefits of all sites and all sponsors and all CROs using a common assessment tool
  • The eClinical Forum, a non-profit, non-commercial discussion/action group comprised of members of the Pharmaceutical and Clinical Research Services industry, along with sites and academia, have developed a regulatory-based assessment tool for clinical research sites to determine if their computer system (EHR, EMR, etc) is appropriate to hold regulated clinical trial data. It has been available for free for over 4 years and is currently being used around the globe by many sponsors and thousands of sites.
  • The eClinical Forum’s free “eSource-Readiness Assessment” (eSRA) that assists the sponsor/site in determining if the site system is appropriate for sourcing clinical research records
  • How a Sponsor/CRO can incorporate eSRA into their processes
eCF Birds-of-a-Feather Webinar: Use of eCOA Metadata to Detect Fraud, Develop Risk Indices and More
  • 1487
  • Article rating: No rating

eCF Birds-of-a-Feather Webinar: Use of eCOA Metadata to Detect Fraud, Develop Risk Indices and More

Sept 25, 2019 presented by Jill Platko and Miko Pietila of Signant Health

Electronic solutions for patient-reported and clinician-reported outcomes provide rich metadata that can be mined for additional insights describing trial performance and driving risk-based monitoring. We will explore the use of this eCOA meta data in fraud detection, and other analytics insights and how these data might translate to risk indices to inform risk-based monitoring activities.

Prominent Industry Magazines address the need for investigator site systems assessment and eSRA
  • 3634
  • Article rating: No rating

Prominent Industry Magazines address the need for investigator site systems assessment and eSRA

Applied Clinical Trials (English), PHARMSTAGE (Japanese)

Electronic Health Record (EHR) systems are being used increasingly by clinical investigative sites; and there is a growing expectation, by regulatory agencies, for clinical trial sponsors to verify that EHR systems comply with requirements to protect confidentiality and provide accurate and reliable data for the use in a regulated research environment. eClinical Forum provides a free tool to assist sponsors and sites in deternining if their EHR systems are appropriate to source clinical research data.

This very important topic has been featured in 2 prominent industry magazines:

Applied Clinical Trials (English, December 2018)

PHARMSTAGE (Japanese, October 2019)

eCF Webinar: Tufts Research: Strategies from Data Management Leaders to Speed Clinical Trials
  • 4299
  • Article rating: No rating

eCF Webinar: Tufts Research: Strategies from Data Management Leaders to Speed Clinical Trials

10-January-2019 at UTC 1600

Facilitator:Hugo Cervantes, Vice President Vault CDMS, Veeva

Learn how top pharmaceutical companies and CROs plan to speed database build and data collection, as well as their top challenges and future priorities. This in-depth research from Tufts follows their industry-wide eClinical Landscape Study, examining the major cause of database build delays and their impact on trial cycle times.

Birds-of-a-Feather Discussion: Considerations When Running Paperless Clinical Trials
  • 3594
  • Article rating: No rating

Birds-of-a-Feather Discussion: Considerations When Running Paperless Clinical Trials

11-October-2018 via webinar (one hour)

Facilitator:    Dr. Jules Mitchel, Target Health

With drug and device manufacturers and the U.S. Food and Drug Administration (FDA) supplying much of the push, so-called paperless clinical trials are gaining momentum. We will discuss the future landscape and regulatory concerns of paperless clinical trials and clinical trial design incorporating mobile tools.

Birds-of-a-Feather Discussion:  Principal Investigator signature / approval on eCOA Data
  • 2608
  • Article rating: No rating

Birds-of-a-Feather Discussion:  Principal Investigator signature / approval on eCOA Data

Date:  Wed, 25 July 2018     Duration: One hour

Facilitator: Shelby Abel, Bioverativ a Sanofi Company

For This Topic:   “Experience with exceptions of PI signature/Approval on eCOA Data. Please bring your experience and thoughts.”  This is a facilitated discussion with the content coming from the sharing of participants experiences, comments, and questions on this topic.

ECF REPRESENTATIVES MEET WITH EMA GCP IWG
  • 10683
  • Article rating: 5.0

ECF REPRESENTATIVES MEET WITH EMA GCP IWG

Meeting With Interested Parties On Topics Related To E-Source Data/ EDC Tools In Clinical Trials

Representatives from the eClinical Forum participated in the meeting with inspectors and observers in London 12th June to discuss challenges and trends in Clinical Research. We presented the work of the eClinical Forum in the areas of contractual requirements and risk-based software validation…  Expand article to read more...

Technology Showcase Webinar: "Developing Your eConsent Strategy - Best Practices "
  • 7068
  • Article rating: No rating

Technology Showcase Webinar: "Developing Your eConsent Strategy - Best Practices "

5 July 2017: Registration Required

Presented by:  Michael Tucker, Senior Product Solutions Specialist, Medidata Solutions

 

Open To: Staff from eClinical Forum member companies

Date : Wed, 5-July-2017         Duration: One hour

Time: UTC 1300:   (09:00 AM EDT, 15:00 CEST, 9:00 PM Singapore)  We apologize for the inconvenient time in some regions.

Click on title for more information

RSS

Theme picker

Not a member?
Visit the Membership page to learn 
How To Become a Member
(Join the eClinical Forum and learn how to leverage existing and emerging technologies for electronic clinical trials. Access an eClinical community, member-only knowledge, events and forums)

«July 2020»
MonTueWedThuFriSatSun
293012345
678
7/8/2020 UTC
102

Birds-of-a-Feather Webinar: Real-world data (RWD) and real-world evidence (RWE)

According to the FDA’s website, “Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions.”  And a recent survey by the eClinical Forum showed that most respondents believe that RWD and RWE will become much more important in clinical research over the next few years.  As a result, many questions have arisen regarding the use cases, data sources, quality of these sources, regulatory guidance documents and so on. The goal of this “Birds of a Feather” session is to present some basic information on these topics and to present a few case examples to illustrate how RWD and RWE are playing an increasingly important role in research. 

Read more
9101112
13141516171819
20212223
7/23/2020 UTC
105

Technology Showcase: eClinical Solutions -- Automating the Clinical Data Pipeline for Enhanced Data Review & Analytics

There has been a dramatic increase in clinical data types, sources and systems in recent years enabling new insights into patient experiences while also presenting challenges in consolidating, standardizing and analyzing these new data streams.  The tools for centralizing, integrating, mapping and analyzing data have not kept pace with research and are causing cycle time delays and require numerous manual processes.  This technology showcase will describe how new platforms like the elluminate Clinical Data Platform are automating the ingestion of data from numerous eClinical systems and sources, enabling faster data mapping and standardization, supporting risk based data review and advancing both clinical and operational analytics.  

Presented by Sheila Rocchio and Sam Parnell of eClinical Solutions.

Read more
242526
272829303112
3456789

Upcoming events Events RSSiCalendar export

  • Birds-of-a-Feather Webinar: Real-world data (RWD) and real-world evidence (RWE) (7/8/2020 UTC)
    7/8/2020 UTC
    102

    Birds-of-a-Feather Webinar: Real-world data (RWD) and real-world evidence (RWE)

    According to the FDA’s website, “Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions.”  And a recent survey by the eClinical Forum showed that most respondents believe that RWD and RWE will become much more important in clinical research over the next few years.  As a result, many questions have arisen regarding the use cases, data sources, quality of these sources, regulatory guidance documents and so on. The goal of this “Birds of a Feather” session is to present some basic information on these topics and to present a few case examples to illustrate how RWD and RWE are playing an increasingly important role in research. 

    Read more
  • Technology Showcase: eClinical Solutions -- Automating the Clinical Data Pipeline for Enhanced Data Review & Analytics (7/23/2020 UTC)
    7/23/2020 UTC
    105

    Technology Showcase: eClinical Solutions -- Automating the Clinical Data Pipeline for Enhanced Data Review & Analytics

    There has been a dramatic increase in clinical data types, sources and systems in recent years enabling new insights into patient experiences while also presenting challenges in consolidating, standardizing and analyzing these new data streams.  The tools for centralizing, integrating, mapping and analyzing data have not kept pace with research and are causing cycle time delays and require numerous manual processes.  This technology showcase will describe how new platforms like the elluminate Clinical Data Platform are automating the ingestion of data from numerous eClinical systems and sources, enabling faster data mapping and standardization, supporting risk based data review and advancing both clinical and operational analytics.  

    Presented by Sheila Rocchio and Sam Parnell of eClinical Solutions.

    Read more
  • Birds-of-a-Feather Round Table Discussion: U.S. National Patient Identifier (NPI) and its Impact to Clinical Trials (8/18/2020 UTC)
    8/18/2020 UTC
    106

    Birds-of-a-Feather Round Table Discussion: U.S. National Patient Identifier (NPI) and its Impact to Clinical Trials

    Presenter/Facilitator:  Ken Light, Clinscape

    In 1996, HIPAA legislation called for the development of a national patient identifier system that would give each person in the United States a permanently assigned, unique number to be used across the entire spectrum of the national healthcare system.   That project was never funded by congress, but just last year (June, 2019) Congress voted to appropriate $99 billion dollars to an HHS bill that included creation of a National Patient Identifier.

    Ken will review this topic, and oversee a group dialog around the benefits, challenges, and impact related to healthcare and clinical trials.   

    Read more
  • eCF Autumn 2020 Virtual Workshop Planned (10/12/2020 - 10/16/2020 UTC)
    10/12/2020 - 10/16/2020 UTC
    103

    eCF Autumn 2020 Virtual Workshop Planned

    Following the success of our Spring Virtual Workshop (see article below), we are now planning for an Autumn 2020 Virtual Workshop. This will replace face-to-face meetings in Asia, Europe and North America due to continued concern for our members safety during the Covid-19 pandemic. It is our hope that we will be able to resume face-to-face workshops in 2021 as our members have expressed their desire to get back to "getting together" in person once it is appropriate to do that, as they say "nothing can replace the networking and comeraderie of an eCF face-to-face meeting".

    The Autumn 2020 Virtual Workshop will build on our success, learnings, and suggestions for improvement from the Spring Virtual Workshop. We plan to have more interactive sessions, more sessions that are regional-based to allow a better time-of-day for most participants, have some global sessions to allow for the valuable global interaction, and spread it over a full week with a few hours/day. We are currently in the planning stage and welcome suggestions to discussion topics via info@eclinicalforum.org as well as considering all suggestions submitted with the Spring workshop evaluations.

    Please mark your calendars for Oct 12-16 2020 ... and stay tuned for more detailed information as we develop it!

    Read more

This form...