Ethical’s BLOG

Stay connected to eAdjudication® news
and Endpoint Adjudication in the eClinical World

Ehical’s Director Mimmo Garibbo and colleagues in Quality Assurance, Software
Engineering and Security bring you news and insight on issues, trends, technology,
developments and noteworthy events in the world of endpoint adjudication.

By Dimitri Stamatiadis, PhD, MBA 18 Sep, 2018

Endpoint adjudication: quality enhancer or unnecessary complication?

By D. Stamatiadis, PhD, MBA, author of “21st Century Technologies, a possible solution for 21st century challenges in healthcare”, conference at the Pasteur Institute, February 20th, 2014. Clinical development is complex and costly by nature. As humanity advances along the path of discovering and using new diagnostic methods, new medic...

Endpoint Adjudication now can use Ethereum Blockchain to guarantee data integrity.

By Mimmo Garibbo 23 Jul, 2018

Ethical eAdjudication Solution for Endpoint Adjudication now can use Ethereum Blockchain to guarantee data integrity.

Audit Trail and the Clinical Data Integrity Challenge The development and manufacturing of pharmaceutical products is regulated by a set of rules called Good Practices (GxP) issued by the International Conference for Harmonization (ICH) and adopted by all regulatory agencies. In order to comply with GxP all data provided by pharmaceutical sponsor c...

Endpoint Adjudication Data for Submission to FDA and EMA - What Should Be Included?

By Mimmo Garibbo 25 Jun, 2018

Endpoint Adjudication Data for Submission to FDA and EMA - What Should Be Included?

TO GET STARTED Before starting any Endpoint Adjudication activities make sure that the following processes are in place and that all relevant documents are finalized and effective (i.e., approved by all applicable stakeholders). 1. Define the type of Adjudication Committees and Membership thereof. 2. Prepare the Endpoint Adjudication Charter includ...

15 Key Topics to be defined in the Endpoint Adjudication Charter (Protocol)

By Mimmo Garibbo 04 Jun, 2018

15 Key Topics to be defined in the Endpoint Adjudication Charter (Protocol)

Adjudication Charter Introduction Study abstract - Adjudication rationale Description of the Clinical Trial, Study objectives (primary, secondary, exploratory, safety) and the rationale for adjudicating endpoints. Clinical Endpoint Committee (CEC) Adjudication roles definitions: Sponsor, Contractors, Chairman, Reviewers (clinicians), Coordinator, S...