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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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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:
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.
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.
Birds-of-a-Feather Round-Table Webinar Discussion: Subject Status Calculations
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 firstname.lastname@example.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.
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.