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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.

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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

Five key drivers to exceed customers’ expectations

At Ethical GmbH, we understand that clinical research has become more complex and more expensive than ever before. Our motivation is to support clinical teams with cost-effective solutions that simplify their daily work without jeopardizing quality. We aim to exceed customers’ expectations by applying to all projects our five key drivers: expertise, flexibility, scalability, customer service, and cost-efficiency.

CEC Member Training

Expertise

We have been delivering innovative solutions for clinical data management for over 25 years and created one of the very first cloud-based platforms for endpoint adjudication over 16 years ago.

edmsb flexible solution

Flexibility

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.

Endpoint Adjudication: Quality Data Management

Scalability

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.

personalise service

Customer Service

Our way of working in close partnership with clinical teams supports a personalized service including the speedy delivery of results and customized reports.

cost efficiency

Cost-efficiency

Our customers receive their own dedicated multi-study platform, an investment they leverage every time they start a new study.

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 platform

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 platform

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 platform

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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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.

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Ethical in Numbers

ethical in numbers

What do Ethical's partners have to say about us?

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What Our Customers Have to Say - Loic Perchenet from Actelion "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
Testimonial 2 "Using the eAdjudication® solution drastically simplifies the whole adjudication process. It can manage the entire process: training, event management, submission, and queries." - Adjudication Coordinator
testimonial 3 "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

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.

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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.

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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.

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How Ethical’s eAdjudication® supports successful endpoint adjudication

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

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Protocol Deviations Glossary Page

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

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