eSource data

eSource data

In a clinical trial, source data that is captured initially into a permanent electronic record used for the construction and evaluation of a clinical study. Any changes made in a permanent record can be assessed via an audit trail.
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The company's eSource data has been accepted by both the Food and Drug Administration and the European Medicines Agency in successful regulatory submissions.
WIRB-Copernicus Group Acquires Clinical Research Technology Firms MedAvante and ProPhase
Accessed on-site or via the Instem Cloud, the Alphadas software solution suite is a proactive early phase CTMS, eSource data capture and reporting system.
Instem's Alphadas Software Suite Goes Live at BioKinetic Europe's N. Ireland Unit
These publications provide clarity around strategies and approaches which can be taken to ensure regulatory confidence in eSource data.
SGS began the process of implementing an eSource data capture system in its Antwerp, Belgium clinical pharmacology unit.
Switzerland : Introducing an eSource system in a Phase I Unit
An early-phase eSource data capture, trial management and clinical site automation specialist, Logos leveraged Medidata's Web Services API to integrate data from its ALPHADAS([R]) Phase I solution with Medidata Rave([R]), an industry-leading system for capturing, managing and reporting clinical research data.
Logos Technologies Joins Medidata Solutions Technology Partner Program
The combination of Cogstate's scientific and adult learning expertise with Clinical Ink's eSource data capture platform will deliver a single solution for sponsors looking to transcend traditional paper-and-pencil assessment scales in clinical trials.
Cogstate and Clinical Ink form strategic alliance to deliver enhanced tablet-based neuropsychological assessments for CNS clinical trials
Study Archive - PHT's Study Archive provides trial documentation in PDF format and eSource data in XML format, on media that is guaranteed by the manufacturer to be readable for 100 years.
PHT Sets ePRO Industry Milestone with 400th Electronic Clinical Trial
This thought-provoking session will debate current esource data definitions and delve into scenarios that demonstrate the use of multiple electronic sources, along with regulatory hurdles.
INC Research Reinforces Commitment to Manage Clinical Trials More Effectively at DIA 2009
Steve Wilson, FDA CDER Deputy Director of Biometrics, emphasized his perspective of "pro-science, pro-standards, pro-technology, and pro-critical path," and the need to ensure the collection of quality data, with the mention of several relevant initiatives, including the CDISC Operational Data Model (ODM), CDISC eSource Data Interchange document, CDISC/HL7 Protocol Representation Group, and standard data collection.
FDA Announces CDISC Will Lead Industry Collaborators to Define Standards for Clinical Data Collection
Kubick will participate in an eSource panel that focuses on industry issues and the development of recommendations relevant to the eSource Data Interchange (eSDI) for clinical trials, as detailed by the group's previously issued whitepaper.
Phase Forward Executives to Present in Key Panels at DIA's 42nd Annual Meeting; To Share Insights on the Benefits of EDC and the Power of Innovative Safety Management Solutions
The high quality of timestamped eSource data and the simple, intuitive user interface of the LogPad are especially important for respiratory trials where frequent assessments are critical to supporting efficacy.
PHT's LogPad System Selected by Asthmatx to Collect Endpoint Data in Pivotal Asthma Trial; Innovative Market-Leading eDiary Solution Features Automated Eligibility Requirement Criteria Calculations
eSource data, or data captured initially into a persistent electronic form, optimizes the clinical trial process by eliminating transcription errors and in the end, shortening the length of the trial.
ADVISORY/PHT Corporation Discusses Ways to Improve eclinical Trials by Incorporating New Technologies and Strategies

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