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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.


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

August 18, 2020

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.   

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

Thursday 23 July 2020

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.

Bird-of-a-Feather Webinar: Agile Development for Clinical Research Software
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Bird-of-a-Feather Webinar: Agile Development for Clinical Research Software

Wednesday, June 17, 2020

Agile computing methods and tools are used in almost all software development today. Alan Yeomans, Quality Manager at Viedoc Technologies AB, will address some of the key issues involved when using agile methods and tools for the development of clinical research software. The theory behind how agile software development can be used for clinical research software will be followed with an example of a working development methodology incorporating agile methods and tools – how does a real software development organisation implement these methods and tools while maintaining regulatory compliance?

Birds-of-a-Feather Webinar:  Tufts-eClinical Solutions "Data Strategy and Transformation Study Results"
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Birds-of-a-Feather Webinar: Tufts-eClinical Solutions "Data Strategy and Transformation Study Results"

Thursday April 30 2020

eClinical Solutions, a member of the eClinical Forum, has collaborated with the Tufts Center for the Study of Drug Development in 2019 to survey pharmaceutical companies about their evolving clinical data demands and the tactics they are employing to manage and leverage their data. Highlights reveal new strategies and digital transformation initiatives being taken. This webinar will share key results from the survey as well as insights and opportunities to use this data to further clinical data architectures. 

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.

This is a round-table discussion and participants are encouraged to share their experiences, ideas and questions on this topic.

The following questions will be discussed:

  • How many subject/patient dispositions do you collect (i.e. Subject completed treatment and follow-up, Subject discontinued treatment and dropped follow-up, Subject discontinued treatment and completed follow-up, etc.)
  • How does subject status get updated in your clinical trial management system?  Automated calculation using a datahub or manual update by monitoring or other personnel?
  • Is monitoring done internally or is there a third party organization performing this task?  If TPO, do they use their own system or your system?  If they use their own system, how does the data get back into your system?
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.

Release: Requirements for Electronic Data for Regulated Clinical Trials "eCF Requirements" V2019 Members Only
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Release: Requirements for Electronic Data for Regulated Clinical Trials "eCF Requirements" V2019 Members Only

eCF Members Release 25-March-2019

The eClinical Forum is happy to announce the V2019 Members-Only release of the “eCF Requirements”. 

The eCF Requirements 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 data which will become part of a regulated clinical trial are consistent with regulatory requirements. The V2019 Members Release has 21 documents mapped.

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Birds-of-a-Feather and Tech Showcase Recordings

Selected events are recorded and are available un-edited for member use only within the "BoF & TS Recordings" folder below.  Not all events will be recorded or released. Recordings are un-edited and are provided for eCF member use only.  Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services, and by necessity are not technology or vendor neutral. The eClinical Forum does not promote nor endorse any particular technology vendors.

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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.   

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Upcoming events Events RSSiCalendar export

  • 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!

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