Endpoint Adjudication: eAdjudication® improved Efficiency & Quality of Actelion SERAPHIN Clinical Trial

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"Using an online eAdjudication portal for our SERAPHIN study endpoints assessment improved the efficiency of the data collection and the quality of our processes, allowing a timely completion of the study.

On-line management of Adjudication allowed rapid assessments of the study endpoints and greatly facilitated the work of the external clinical experts. The tool provided them an integrated quality controlled environment and all the information and forms required to assess the submitted endpoints.

Loïc Perchenet, PhD Director, Global Post-Approval Studies Global Medical Affairs Actelion Pharmaceuticals Ltd.

CLINICAL ENDPOINT ADJUDICATION
Clinical Endpoint Adjudication improves the quality of clinical trials where endpoints are complex to assess, include subjective components and/or cannot be blinded.
The central assessment of efficacy or safety events, made by a panel of independent experts following a blinded standardized procedure, in-creases accuracy, independency and homogeneity of judgments.

Using an online eAdjudication® portal to manage the Adjudication pro-cess provides even more advantages in terms of:

  • Data Quality easing the building and delivery of the events’ information package to the experts through standard automated procedures.
  • Process Quality exploiting role-based workflows to enforce the compliance of the whole process with Sponsor SOPs.
  • Time & Cost savings for the Sponsor reducing cycle times to assess an event as a study end-point; for the independent Experts supporting their decisions with an easy to use system and its tools to deal with data visualization, version-ing and assessment.

ETHICAL eADJUDICATION
Ethical eAdjudication® is a cloud online portal designed to support clinical endpoints assess-ment and adjudication by expert clinicians.

The system is focused in providing the adjudica-tion committee members with accurate, clean and complete data, coming from different data sources (CRF or e-CRF, site documents, images, external providers), and to manage members roles in order to implement a well predefined, fully transparent and documented operating pro-cedure for assessment, thus leading to reliable results.

Main system functions are about:

  • real time events & materials submission and notification;
  • centralized repository and tools to visualize, compare and track event information (data, doc-uments, images);
  • experts’ judgement acquisition through online forms specially designed to guide the experts during the assessment;
  • users’ profiles strict management and process workflow enforcement;
  • audit trail and GxP validation to ease system regula-tion compliance. 

RESULTS

Actelion time and costs for events’ package delivery and assessment tracking were significantly reduced.

Experts time and training effort were minimized through simple online forms and role based pre-defined operations.

Process compliance to the Adjudication Charter, SOP and Regulations were enforced and controlled by running the system in a validated environment.

The SERAPHIN Study was a great success for Actelion and for patients suffering the Pulmonary arterial hypertension (PAH) chronic disorder.

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