Event's package creation
Three ways for the event's creation can be combined and sequenced in the same study configuration:
interactive upload of one of more documents;
interactive data entry of key variables or patients narratives;
integration with patient's data source systems (e.g. Medidata Rave, Oracle Argus, DICOM Imaging, etc) through web services and integration API.
Management of events' info review
visualization / comparison of data or documents included in the package;
merging of documents and key variables in a single narrative doc;
event documentation update and versioning;
event package status tracking.
Management of the committee members
user profiles and roles management;
dynamic assignment of events to Members;
reviewers qualification assessment and training;
communication and alerting to reviewers.
Management of the assessment delivery
enforcement of workflows customized to map the Adjudication Charter;
assessment acquisition through EDC like online Case Report Forms (single or multi-page);
"more data" requests & query to site handling;
Minor and Major Disagreement management;
Consensus meeting management;
adjudication process tracking with Audit Trail.
Reporting & data export
smart real time reporting through Adjudication Coordinator Dashboard;
Quality Control real-time dashboard;
reporting to study Sponsor management;
multi-format data export (PDF, XML, SAS, Excel, etc);
adjudication key data direct export/integration with external Data Management systems.
Report & Compliance
Project Management Real Time Dashboard
Quality Control Real Time Dashboard
Medical records Management
Adjudication Committeee Management
Disagreement - Consensus Management
Data and Documents self-service Export
Hosting and Complete software Management
Credit card required: No
eAdjudication ® is provided as All Inclusive Cloud Software Service
eAdjudication software is provided as a service package bundled together with all the hosting, technical management, validation, training & support:
unlimited users Licenses of the software;
system configuration to map the Adjudication Charter and Workflows;
ISO 27001 cloud hosting for system and database;
server, database and study data complete technical management;
standard users support / integrated online Helpdesk;
standard users training / testing in a Clone "Stage" environment;
validation package documentation & support.
Does this service offer guides, tutorials and or customer support?
eAdjudication is a cloud software services and includes all the activities need to design, manage, train and GxP software validation
Does this service offer multi-user capability (e.g. teams)?
The eAdjudication platform is a multi-study environment with user profiles on a per-study basis
What platforms does this service support?
Cloud Based web application
Who are the main user groups of this service?
Academic Research Organizations; Clinical Research Organizations; Pharma & Biotech Companies; Medical Devices Companies; Imaging Companies.
What is this service generally used for?
To support with a complete software service the process of Central Endpoint Adjudication by a Committee of blinded Expert Clinicians.
Mainly used in Clinical Trials for drug and Medical Devices development.
What are some applications this service is commonly used in tandem with?
Electronic Data Capture (EDC) - Medical Imaging Databases
Does this service offer an API?
APIs are available for Event Dossier building through Medical Records collection from external source systems