As an industry leader in Data Monitoring Committee (DMC) management, our DMC deliberates over un-blinded data to provide recommendations to the sponsor as to whether a trial is continued, modified, or stopped due safety concerns, overwhelming benefit, or treatment futility. The design and delivery of our DMCs harmonize with FDA, EMA, and ICH guidance.
We work with clinical trial sponsors, academic experts, and regulatory agencies to focus on providing the best committee solutions on the market to enhance trial integrity by providing independent, unbiased recommendations to our sponsors. With our global network of more than 550 medical experts who serve as committee members and a proprietary technology platform that provides “easy to evaluate” data packages, WCG streamlines operations for effective decision-making.
Our global network of more than 550 medical, statistical, and safety experts represent more than 25 countries, 75 therapeutic sub-specialties and approximately 250 global academic institutions. These experts — from a wide variety of backgrounds, geographic locations, and therapeutic specialties — are available to serve as committee members and/or expert advisors in the clinical development process.
Over the past two decades, we have recognized that the proper expertise and the ability to deliver timely analyses are key to effective DMCs. Allow us to deliver that to you: schedule a consultation.
A team with deep expertise in data and clinical trial conduct
An unbiased, objective third party; versus working with reviewers with a lack of vested interest in the clinical trial
Clear, timely communication before new projects, which ensures understanding and agreement on expectations and availability requirements
Significant time and expense savings in member recruitment, onboarding, and training
Easy-to-use technology and decision support tools
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 550 members to enable more informed decision-making. Their expert reviews deliver reliable, trusted information to support critical decisions around clinical development programs.
To explore how we can help with your scientific review requirements, 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.