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CLINICAL COMMITTEES TRUSTED EXPERTS

Clinical and Endpoint adjudication (CEA), Protocol Deviations (PD), Data and Safety Monitoring Boards (DSMB), and Data Monitoring Committees (DMC) management on cost-effective, compliant software solutions for over 16 years.

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.

We can help you exactly where you need

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:

     platform and service

A full portfolio to help you efficiently manage your Clinical Committees

As the Clinical Committees Trusted Experts, Ethical helps you manage smoothly and efficiently your independent clinical committee processes with compliant, validated software & custom support. 

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eAdjudication® for independent clinical adjudication

Flexible software with customised support to help sponsors, AROs and CROs manage their independent Clinical Adjudication Committees.

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eDSMB® for independent Data & Safety Monitoring Boards

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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eDeviation® for Protocol Deviation Committees

Flexible software with customised support to help sponsors, AROs and CROs manage independent or internal Protocol Deviation Committees.

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eDSMB Software

A dedicated software
for safety data reconciliation 

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.

Ensuring Quality Compliance with Ethical

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).

 

Certified ISO-IEC 27001 Systems, Services and Data Processing

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.

Integrated Validation Documentation and Support

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.

GDPR - EU General Data Protection regulation Compliance

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)

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We are EU-GDPR compliant: Your data will never be used improperly



Download Ethical eAdjudication for Endpoint Adjudication Dossier

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9 must-have elements of a DSMB SOP

Here are some instructions on writing the right SOPs for DSMB operations.

dsmb sopREAD MORE

How Ethical’s eAdjudication® supports successful endpoint adjudication

Let’s review the software-integrated six-step process that supports endpoint adjudication performance.

endpoint adjudication processREAD MORE

Protocol Deviations Glossary Page

The list of Terms and Definitions related to Protocol Violations, Deviations, and Exceptions.

what is protocol deviationREAD MORE