Flexible software with customised support
for clinical committee management
With our highly flexible and scalable cloud platforms and customised support approach, we help clinical trial teams set-up and run efficiently their independent committees and data management processes, saving time, reducing costs, and ensuring compliance with the stringent EMA and FDA regulations.
Ethical’s team and network of experienced professionals provide ad-hoc services at any step of your committee management from charter design to study archival. Recognizing that each organization needs a different combination of services, we let you choose among the following components:
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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.
Ethical’s approach to quality, compliance, and privacy is simple: be expert, be thorough. That is why our business processes, systems, and services are compliant with all appropriate regulations: GxP, US 21 CFR Part 11, EU GMP Vol. 4 Annex 11, EU General Data Protection Regulation (GDPR).
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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