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  • 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

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2020 is our 20th Anniversary Year!
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2020 is our 20th Anniversary Year!

A lot has happened in electronic support for clinical research in the last 20 years ... and eClinical Forum has been there discussing it all!  We are pleased to be celebrating our 20th anniversary year, stronger than ever with 45+ member companies (and growing), meetings on 3 continents, global webinars that have been attended by members in over 25 countries, very active project teams, meetings with regulators, and freely adding to the knowledge base of the industry. Any organization working in this space is welcome to join. Please see the membership tab on our website (www.eclinicalforum.org) or contact us for more information!  info@eclinicalforum.org

REGISTRATION OPEN: eClinical Forum 2020 Spring Meetings replaced with Virtual Global Workshop 11-13 May 2020
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REGISTRATION OPEN: eClinical Forum 2020 Spring Meetings replaced with Virtual Global Workshop 11-13 May 2020

Getting our members together to talk out the current issues and do creative problem-solving is what we do best. Sadly, due to the Covid-19 Pandemic, the following meetings are cancelled:

April 27-29 2020:  Helsinki Finland, hosted by Signant Health

May 11-13 2020:  New Jersey, USA hosted by Diligent Pharma

But that doesn't mean we won't be "getting together"! We are announcing our "Virtual Global Workshop" for 11-13 May 2020.

Expand the article for the workshop agenda and registration details.

Birds-of-a-Feather Round-Table Webinar Discussion:  Subject Status Calculations
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Birds-of-a-Feather Round-Table Webinar Discussion: Subject Status Calculations

Date: Tuesday, April 21 2020 Duration: One hour

Facilitator: Lisa Jones-Moore, Clinical Systems & Supplies Planning, Eli Lilly & Co.

Open To: Staff from eClinical Forum member companies  (If you are not an eCF member, please review our website www.eclinicalforum.org for membership information or contact info@eclinicalforum.org )

Background: eClinical Forum webinar sessions focus on the details of a specific topic.  All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.

eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials"
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eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials"

V2019PR March 2020

The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2019PR”.

ABOUT THE ECF REQUIREMENTSThe eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial.  We have reviewed regulatory documents from the FDA, EMA, PMDA, and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if systems that data which will become part of a regulated clinical trial are consistent with regulatory requirements and if systems and process that manage these data have the necessary features.

eCF Webinar: Industry Standard HL7 FHIR as used to integrate Sponsor’s EDC system with Site’s EHR System
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eCF Webinar: Industry Standard HL7 FHIR as used to integrate Sponsor’s EDC system with Site’s EHR System

March 24 2020

This presentation will focus on how to reduce the amount of manual data entry for Site users by leveraging Health Level 7 (HL7) Fast Health Interoperable Resources (FHIR) standard.  Some sponsors are using FHIR to automate data entry of the EDC System’s Case Report Forms by integrating with their Site’s EHR System. This is an exciting trend that is in very early stages of adoption across the industry. We will hear from a site regarding how they send data (local labs, vitals, demographics, EKG, etc. ) directly to their sponsors and CROs via data file extracts and FHIR. We will hear from a technology vendor who has adopted the FHIR standard.

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

This document is written specifically for Sponsors to assist them in determining how to fit eCF's eSource-Readiness Assessment (eSRA) into their procedures for determining if data which originated on a  site's electronic health record system is suitable for use in their clinical trial. It shows the benefits of using a common assessment tool, provides suggestions for implementing eSRA, and shows a mapping of eSRA questions to regulatory authority statements/expectations.

Birds-of-a-Feather Webinar & Discussion:  Investigator Oversight on eCOA data - what is a good evidence?
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Birds-of-a-Feather Webinar & Discussion: Investigator Oversight on eCOA data - what is a good evidence?

January 29 2020; facilitated by Cinzia Piccini of Eli Lilly

As there are no regulatory detailed expectations on oversight by investigators on eCOA data, multiple approaches have been adopted across the industry (from log-in as evidence to notification/alerts or investigator signature on eCOA data). In general, as per other data sources, oversight for eCOA data should be continual and not once at the end of the study. In addition, oversight activities should be right-sized according to the criticality of the data and protocol requirements for compliance. Evidence of the oversight should be available during the conduct of the trial and enduring for the entire retention period.  The aim of this webinar is to allow participants to share different approaches and any knowledge of current expectations by regulatory inspectors.

 

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«March 2020»
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2/25/2020 - 2/26/2020 UTC
93

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

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
Read more
26
2/25/2020 - 2/26/2020 UTC
93

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

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
Read more
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79

eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials"

The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2019PR”.

ABOUT THE ECF REQUIREMENTSThe eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial.  We have reviewed regulatory documents from the FDA, EMA, PMDA, and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if systems that data which will become part of a regulated clinical trial are consistent with regulatory requirements and if systems and process that manage these data have the necessary features.

Read more
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16171819202122
2324
3/24/2020 UTC
95

eCF Webinar: Industry Standard HL7 FHIR as used to integrate Sponsor’s EDC system with Site’s EHR System

This presentation will focus on how to reduce the amount of manual data entry for Site users by leveraging Health Level 7 (HL7) Fast Health Interoperable Resources (FHIR) standard.  Some sponsors are using FHIR to automate data entry of the EDC System’s Case Report Forms by integrating with their Site’s EHR System. This is an exciting trend that is in very early stages of adoption across the industry. We will hear from a site regarding how they send data (local labs, vitals, demographics, EKG, etc. ) directly to their sponsors and CROs via data file extracts and FHIR. We will hear from a technology vendor who has adopted the FHIR standard.

Read more
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