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About Ethical

Ethical Grew Up With the eClinical World and Introduced eAdjudication® Solutions to It

Beginning as eClinical developers, our staff gained experience spanning the range of the eClinical world: eClinical technology, clinical systems, and data management in global trials, clinical trial quality and data compliance, and of course, endpoint adjudication (EA). We gained the experience in successful engagements with academic research organizations (AROs), biopharmaceutical or medical device enterprises, clinical research organizations (CROs), and independent review committees. We have become expert in the creation, performance, and management of the EA process workflows and forms validation, private health information management and compliance, clinical trial and GxP compliance, clinical systems design, integration and management, as well as web and mobile interface design.

Our Mission

“Trial sponsors should by now have had enough of meaningless software complexity, oversized budgets, and absurd timelines.” Mimmo Garibbo, Director

When we founded Ethical in late 2013, we knew that trial sponsors needed faster and simpler adoption and integration processes for EA software.
Our approach built upon our staff’s experience in providing software solutions to support some 300 international clinical trials with more than 10,000 investigator sites and hundreds of thousands of patients. The result: a combination of out-of-the-box, effective Endpoint Adjudication features and complete technical infrastructure management using a cloud software-as-a-service provisioning model.
The software we deliver is complemented by the quality, empathy, flexibility, customization, and openness to integration that we consider to be strategic keys. The name Ethical embodies the importance we accord to the sensitive data services we provide and to the working relationship we have with our customers and the patients they serve.
In sum, we want to provide our customers with the best solution to manage the clinical endpoint independent review and adjudication process in a simple, effective, and GxP-compliant way.

 

Our History

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1997

Working as GM Servizi, the team began with an assignment to design a web application to collect adverse events, a subject the team had no clue about. However, energy and enthusiasm led the team to rapidly learn how safety and quality assurance affect clinical trials.

2001

In 2001, our team began a long-term relationship with Actelion, a Swiss biotech startup with a brilliant future. (In 2017, Johnson & Johnson acquired Actelion for $30 billion in cash.)
For Actelion and other customers, our staff traveled around the world, training investigators and supporting clinical studies data management, working with clinical development departments to develop the software necessary to deliver study tracking, data collection, queries management, coding, reconciliation, adjudication, protocol violations, laboratory results management, data review, narratives, supply management, document sharing, and much more.

2004

In 2004, we delivered our first eClinical software as a managed cloud service, well before the cloud market boom. Hosted by our data center and technically managed by our staff, customers accessed the software through a standard browser connection. This solution immediately freed customers to focus better on their tasks without having to concern themselves with technical issues.

2008

In 2008, the team achieved ISO/IEC 27001 certification, which recognizes that we manage customer data according to the highest international quality standards. Together with the extensive eClinical experience gained in work performed for so many trials, this infrastructure milestone was the final piece to add to the capabilities now employed by Ethical to provide and support its eAdjudication® software and services for Endpoint Adjudication customers.

2014

Ethical was founded in 2014 as a new venture focused on Endpoint Adjudication Solutions by a team that has been working in eClinical since 1997

Our Leadership

Ethical GmbH, owned and controlled by GM Servizi, is a new EA venture of a team with deep eClinical experience.

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Mimmo Garibbo

Director and Founder since 2013 
Education: Business Administration
Focus: Company management and business development

Beat Widler

Head of Quality Assurance
Focus: Over 25 years with Roche in Switzerland and the UK in the areas of regulatory affairs, clinical research and Quality Assurance & Risk Management. For 15 years, he was Global Head of Roche Clinical Quality and 5 years the Head of Roche Clinical Development UK. Representative for more than 15 years on IFPMA, EFPIA, Interpharma working groups and delegations to Health Authorities.

Simone Suriano

Software Engineering, R&D
Focus: Development and Software Design Lead. Simone knows how to make and manage robust software.

Massimiliano Grillo

Software Engineering, R&D
Adjudication® Software Project Leader

Luca Morbelli

Quality Assurance– Computer System Validation Manager

Carlo Rocca

CIO & Security Manager
Focus: Supports Ethical and its services machinery. 

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In order to shed light on endpoint adjudication, the LinkedIn Endpoint Adjudication Community generated an Events Charter Template for endpoint adjudication to assist those in need of guidance.

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The Academic Research Organization Stanford Center for Clinical Research (SCCR), has adopted Ethical Clinical’s eAdjudication® cloud-based platform to manage the central assessment of clinical trial endpoints (CEC).

Endpoint Adjudication: Stanford Center for Clinical Research Adopts Ethical eAdjudication Cloud-Based PlatformREAD MORE