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

Investigator Site File (ISF Assessment)

Investigator Site File (ISF Assessment)

Developing a questionnaire to assist sites in evaluating their e-Investigator Site File systems against clinical research regulatory regulations and recommendations.

Agenda Available: eClinical Forum Americas Workshop

14-16 November 2022

Agenda Available: eClinical Forum Americas Workshop

This meeting is kindly hosted by Merck at their Training Facility in North Wales, PA.  We are currently accepting suggestions for agenda topics and/or presenters in the areas of  Decentralized Clinical Trials, Real World Evidence, Digital Health Technologies, Trends in Clinical Research, AI/ML case studies, Regulatory Updates, and Emerging Roles/Responsibilities.

eCF Technology Showcase: Clinical ink - "Tying Passive Data Collection to Active Mobile Measurements"

Wed, 7-Sep-22 at UTC 1400

eCF Technology Showcase: Clinical ink - "Tying Passive Data Collection to Active Mobile Measurements"

This technology showcase will present how to unlock the value of passive data collection in clinical research by tying the rich, voluminous patient data compiled by mobile sensors and wearables to active mobile measurements.

eCF Focus Session on "Using RWD and RWE in Clinical Trials"

Wed, 13-July-2022 at UTC 1400

eCF Focus Session on "Using RWD and RWE in Clinical Trials"

This is a Panel Discussion "Using RWD and RWE in Clinical Trials" - Explore challenges and opportunities to leverage real world data to accelerate and optimize clinical trial decision making.

Birds-of-a-Feather Round Table Discussion: Measuring Clinical Trial Data Quality

Wednesday, 10-Aug-2 at UTC 1400

Birds-of-a-Feather Round Table Discussion:  Measuring Clinical Trial Data Quality

We will be discussing the general GCP expectations to perform “Quality control” to each stage of trial data handling to ensure that all data are reliable and has been processed correctly. This single statement has very broad interpretations and in this session we can enable the discuss focused the application over Clinical Data Management.

REGISTRATION OPEN: eClinical Forum Hybrid Workshop, New Jersey June 8-10 2022

Old York Cellars Winery, Ringoes New Jersey USA

REGISTRATION OPEN: eClinical Forum Hybrid Workshop, New Jersey June 8-10 2022

We are pleased to announce that registration is open for our hybrid workshop at the Old York Cellars in Ringoes, NJ on June 8-10 2022. We are very excited that we can offer this safe and fun venue as we will be meeting in an open-air event tent amidst their beautiful vineyard. Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange, contribution to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A as well as evening networking events.  For those who cannot join in person, some of the sessions will be live-streamed and recorded.

eCF BoF Webinar: Principal Investigator's Signature: Best Practices

Wed, 27-April-2022

eCF BoF Webinar: Principal Investigator's Signature: Best Practices

 The eCF’s PI Signature Working Group have updated their 3-year-old document which is released to eCF Members in early April.  They will introduce the 2022 changes to the best practice document for Investigator’s signature on electronic Case Report Forms (eCRFs).  Participants are encouraged to share their thoughts on:

- how to provide continuous monitoring of regulatory expectations;

- sharing members’ experience on implementation and regulatory findings (if any);

- brainstorming for an industry definition of the “meaning” of signature on data reported to sponsors during both traditional and non-traditional clinical trials.

Presenters:   eCF PI Signature Team Leaders:  Cinzia Piccinia (Eli Lilly) and Babette von Hagen (CSL Behring)

eCF Technology Showcase: eClinical Solutions - "Leveraging a Digital Accelerator

5-April-2022 at UTC 14:00

eCF Technology Showcase: eClinical Solutions - "Leveraging a Digital Accelerator

eClinical Solutions Technology Showcase: As the volume, variety and velocity of data sources available for use in clinical research have grown, the need has arisen for a modern data infrastructure that automates data processes from ingestion through submissions.  75% of Life Sciences companies are still using Excel and SAS to integrate data sources slowing time to insight for data review teams, reducing collaboration and extending traditional cycle time metrics like LPLV to DBL.

eClinical Solutions, and eClinical Forum Member company, offer elluminate Clinical Data Cloud as a foundation of modern digital trials. This session will demonstrate the numerous capabilities in the platform that replace manual processes in the data lifecycle. They will share frequent uses cases and the business outcomes data management, medical monitoring, statistical analysis and clinical programming and clinical operations teams experience when using the elluminate Clinical Data Cloud.   

eCF BoF Round-Table: Suppliers/Vendors Oversight: Best Practices

Thurs, 17-March-2022 @UTC 1400

eCF BoF Round-Table: Suppliers/Vendors Oversight: Best Practices

Facilitator:           Manuela Hornberger, Boehringer Ingelheim   

Open To: Staff from eClinical Forum member companies gratis  (If you are not an eCF member, please review our website www.eclinicalforum.org/membership 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.

eCF Technology Showcase: Veeva CDB - Creating a Foundation for Digital Trial Data / Decentralized Trials

Wed 16-Feb-2022 @ UTC 16:00

eCF Technology Showcase: Veeva CDB - Creating a Foundation for Digital Trial Data / Decentralized Trials

Conducting decentralized trials is an important pathway to improving patient centricity, yet they create painful data management challenges that increase costs and delay access to reliable data. As companies move toward digital trials, the number and variety of data sources grows, and visibility into your data declines. Most modern trial designs, including adaptive trials, need interim analyses which require timely access to reliable data.  In this technology showcase, Veeva will share their clinical database, Veeva CDB, and demonstrate how it produces a complete and concurrent view of the clinical data. Decentralized trials run better with centralized data management that can speed database locks and support better decision-making during study conduct.

eCF 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.

eCF Round-table: Electronic Investigator Site Files (eISF)

Tues 25-Jan-2022 (UTC 16:00) or Wed 26-Jan-2022 (UTC 08:00)

eCF Round-table: Electronic Investigator Site Files (eISF)

This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. We will be discussing challenges Sponsor companies are having evaluating, monitoring and documenting a site’s eISF, and to share best practices, challenges, and ideas. 

Facilitators:   Ronit Elstein (Pfizer, US) Martijn Griep (Janssen, Belgium)

eCF Webinar: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials.

January 11, 2022

eCF Webinar: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials.

We will be discussing a recent eCF/EUCROF positions paper: 

The full history of a clinical trial describes the conduct of the trial and the quality of the data produced. Changes in technology and the evolution of regulatory expectations on electronic systems over the past two decades have resulted in a situation where additional supplementary documentation is needed to reconstruct some clinical trial activities. Many of the computerised systems used during a trial are only used during the active trial data collection stage. This period of use is shorter than the retention period required for the archiving of the essential documents of the trial. Furthermore, the documentation that makes up this history is distributed between sponsor, investigators and vendors. Data is stored locally, in the cloud, on patient devices, at vendors, and sub-vendors. Where the data is archived (sponsor, investigator, vendor), in what format (kept live or static), and for how long are issues discussed in the position paper.  You can download the position paper here: Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1 (eclinicalforum.org)

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eCF Views & News

eCF Views & News

We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.

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eCF Birds-of-a-Feather Webinar:  EHR-EDC Integration – Implementation Overview and Learnings

eCF Birds-of-a-Feather Webinar:  EHR-EDC Integration – Implementation Overview and Learnings

Implementing EHR-EDC integrations is an emerging area of focus in the pharma industry.  This presentation will share an overview of implementing an EHR-EDC integration on 2 studies and the associated lessons learned.   Following this overview will be a group discussion on such integrations and prospects for broader adoption within our clinical trials. 

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eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023

eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023

The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023"

ABOUT THE ECF REQUIREMENTS:  The 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, NMPA, MHRA 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 source or manage 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.

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