Innovative software with customised support
for clinical committee management
Streamline processes without compromising quality: Clinical Adjudication, Protocol Deviations, Data and Safety Monitoring Boards, Data Monitoring Committees, Steering Committees and more.
Our IT teams configure the software to match exactly your charter. From User Requirements Specifications to study archival through GxP validation, we support you throughout your clinical committee management process.
We have been delivering innovative solutions for clinical data management for over 30 years and created one of the very first cloud-based platforms for endpoint adjudication over 18 years ago.
We are passionate about new technologies, and we take pride in always leveraging the latest innovations where they can contribute to save time and improve data quality.
Our flexible software can match any study design or data management architecture leaving our customers free to choose exactly the level of support they need in every phase of their study.
We serve small and medium-sized organizations as well as multinational sponsor companies, and we can handle both small and large studies as well as unlimited users.
Our way of working in close partnership with Sponsors, CROs and AROs supports a personalized service including the speedy delivery of results and customized reports.
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Flexible software with customised support to help sponsors, AROs and CROs manage their independent Clinical Adjudication Committees.
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Flexible software with customised support to help sponsors, AROs and CROs manage their independent Data & Safety Monitoring Boards (DSMBs) and Data Monitoring Committees (DMCs).
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Flexible software with customised support to help sponsors, AROs and CROs manage independent or internal Protocol Deviation Committees.
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Equipped with automation features, smart tools and hands-on task management features, eReconciliation® allows data management, clinical and safety teams to perform reconciliation all along the study duration with minimum burden while keeping a full audit-trail as requested during regulatory inspections.
"This current system is undoubtedly worlds easier than a manual review. Reduces scan, signature, and upload times and ensures that everything is in order."
- Adjudication Committee Member
"Using the eAdjudication® solution drastically simplifies the whole adjudication process. It can manage the entire process: training, event management, submission, and queries."
- Adjudication Coordinator
"I find Ethical GmbH very innovative and flexible. They find solutions to all our requests and they constantly adapt to different volumes of events even with short notice."
- Sponsor's Study Leader
Ethical’s software and business processes are built to meet globally recognized industry standards and regulatory requirements. These include the ISO/IEC 27001 for Information Security Management (ISMS), Good Clinical Practice (GCP), US FDA 21 CFR Part 11, EU GMP Vol. 4 Annex 11, the EU General Data Protection Regulation (GDPR), and GAMP 5 Documentation.
Ethical software design and the associated services are based on a hardware/software and organizational structure that ensures compliance with the ISO/IEC 27001 Information Security Management System (ISMS) requirements and security controls. Ethical's parent company GM Servizi is audited yearly by an authorized ISO 27001Certification Authority.
Ethical’s softwares, systems, and services comply with all regulations that apply to EA: GxP, GAMP 5, US 21 CFR Part 11, EU GMP Vol. 4 Annex 11.
Ethical provides the full GAMP 5 validation documentation package and support.
Ethical GmbH is committed to ensuring the security and protection of the personal information and to provide a compliant and consistent approach to data protection. We have a robust and effective data protection program in place which complies with European Union General Data Protection Regulation (EU-GDPR)
eAdjudication
software solution
service description
Here are some instructions on writing the right SOPs for DSMB operations.
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Let’s review the software-integrated six-step process that supports endpoint adjudication performance.
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The list of Terms and Definitions related to Protocol Violations, Deviations, and Exceptions.
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