The growing complexity of protocols is resulting in longer cycle times, rising costs and increased pressures on staff and patients throughout the clinical trial process. Tufts Center for the Study of Drug Development (CSDD) studies have found that the number of endpoints, procedures and eligibility criteria of typical Phase III protocols increased significantly, and have continued to grow. These factors combine to increase the risks, costs, and burdens on research teams.
Leveraging a Protocol Design Review from WCG’s global network of clinical and medical experts will improve the quality of your study design, ensure you are targeting the right patient populations, reduce the frequency of protocol amendments, and better inform the decision-making processes.
Let our experts review your protocol, the early investment will ensure your study—and overall investment—meets its full potential. Our expert review services include:
Evaluation of endpoints, sample size, study procedures and inclusion/exclusion criteria—to ensure the protocol makes sense from a scientific and regulatory perspective
Perspectives to minimize the potential variability in the results of the study
Expert analysis to increase the regulatory confidence in trial endpoints
Contact us to schedule a protocol review with our experts.
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.
When you have our experts review your protocol, the early investment ensures your study—and overall investment—meets its full potential. To start, simply fill out the form.