Endpoint Adjudication

Achieve quality clinical trial outcomes with an expert Endpoint Adjudication Committee

There is a growing trend across a wide variety of therapeutic areas and medical device studies to adjudicate critical endpoints, outcome events, and even inclusion/exclusion criteria that determines whether patients are eligible for a specific study. That’s why, with an Endpoint Adjudication Committee, you can achieve quality clinical trial outcomes and reduce inconsistencies or bias in clinical trial data.

5 days average time from posting to adjudicator decision
100% on-time final adjudication database lock (DBL) prior to final study DBL
32 days average time for entire adjudication process
Ensure the quality of your clinical trial

With WCG’s Endpoint Adjudication Committee (EAC) process, also known as a Clinical Events Committee (CEC), we help the biopharma and device industry to lower the risk of variation in important clinical trial outcome events for submission to regulatory agencies.

Our independent endpoint adjudication process enhances safety and efficacy in:

  • Studies with complex and/or subjective endpoints;
  • Studies which cannot be blinded;
  • Studies with high enrollment or long duration;
  • Studies with global or cultural differences across sites;
  • When the endpoint of interest differs from the therapeutic specialty of the investigator.

Endpoint Adjudication is a critical aspect of a clinical trial as it helps to lower the risk of variation in important clinical trial outcome events for submission to regulatory agencies. From a global perspective, our Endpoint Adjudication service reduces regional variation in outcome reporting and also serves as a quality control check that uses clinical expert review of principal investigator reporting.

When you need thorough insights, turn to a network of 1,000+ global experts

Our Endpoint Adjudication Committees are run by a dedicated team of more than 1,000 medical, statistical, and safety experts who serve as advisors to clinical trial sponsors, academic experts and regulatory agencies. Their main objective is to reduce the variation in important clinical trial events and ultimately mitigate risk and enhance patient safety in clinical trials.

Sponsors who tap into WCG’s network committee:

  • Achieve consistent, global data collection
  • Catch safety issues early on
  • Assess risk with event findings
  • Bolster regulatory strategy prior to submission
  • Gain expanded labeling
  • Drive increased adoption through publication support
  • Gain a competitive advantage over other products

Interested to learn more? Schedule a consultation with our experts.

Our expert committees are supported by purpose-built adjudication technology

Our proprietary AIMS™ technology is purpose-built for endpoint adjudication committee management. AIMS streamlines processes and diminishes administrative burden, allowing committee members to focus on providing their expert assessments. AIMS makes online data review and communication as seamless as possible for committee members, sponsors and other personnel spanning the globe.

We administer the system while managing data and content to ensure appropriate review and a complete audit trail for all activity. With the power of AIMS, and the support of our experienced project oversight, we make endpoint adjudication committee member recruitment, training, invoicing, communication, and overall adjudication committee management as straightforward, efficient and constructive as possible.

View AIMS Contributor Demo

View AIMS Member Demo

 

Key features of the AIMS platform:

  • Entirely web-based approach to adjudication management
  • Easy system training with documented certification
  • Customized role and task-based access for Sponsors, Sites, EAC Members, Vendors, CRAs, etc.
  • Intuitive workflows and helpful prompts, reminders, and alerts to complete tasks correctly and efficiently
  • Secure source document upload
  • Integrated translation workflows within the platform
  • Consistent, pre-packaged case packets
  • Built-in DICOM imaging viewer/reader
  • Built-in redaction tools
  • Simple one-page voting form with built-in skip logic
  • Automated distribution of cases to committee members for independent voting
  • Electronic data capture of voting forms with edit checks
  • Real-time reporting capabilities
  • 21 CFR Part 11 regulatory compliant validation

WCG Endpoint Adjudication is powered by ACI Clinical

Enhancing trial integrity and reducing variation in important clinical trial events are critical components of risk mitigation and patient safety. To improve the quality and effectiveness of clinical trial data requires regulatory expertise; through ACI’s endpoint adjudication and data monitoring safety committees, sponsors and CROs can benefit from a network of 1,000 members to enable more informed decision-making. Their expert reviews deliver reliable, trusted information to support critical decisions around clinical development programs.

Let’s discuss how WCG can help improve your trials' safety and efficacy

To see if your trial would benefit from an Endpoint Adjudication Committee, we suggest an exploratory conversation to assess your plans and how our capabilities can be leveraged to assist. To start, simply fill out the form.