Trial Design and Protocol Planning

Optimize your clinical development strategy with expert collaboration on trial design, study protocol, and regulatory interactions

Trial designs and regulatory landscapes have become increasingly complex. 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 have increased significantly and have continued to grow. These factors combine to increase the cycle times, risks, costs, and burdens on research teams.

Leveraging Trial Design and Protocol Planning from WCG’s global network of clinical, medical, and statistical experts will improve the quality of your study design, ensure you are targeting the right patient populations and identifying appropriate endpoints that are measurable and interpretable, reduce the frequency of protocol amendments, better inform the decision-making processes, and increase the overall validity and quality of your studies.

Get access to a team of experts, when you need it most

An early partnership with experienced advisers will ensure your clinical development planning—and overall investment—meets its full potential. Our expert services include:

Trial Design and Protocol Development, including evaluation of endpoints, sample size, statistical analysis plans, study procedures and inclusion/exclusion criteria—to ensure the protocol makes sense from scientific and regulatory perspectives

Perspectives to minimize the potential variability in the results of the study

Expert analysis, including writing and implementing statistical methods to address missing data, to increase the regulatory confidence in trial endpoints

Contact us to schedule protocol development support or review with our experts.

WCG Clinical Development Planning is powered by Statistics Collaborative and ACI Clinical

Statistics Collaborative has designed trials and helped develop protocols in many disease areas across all phases of drug development. The statistical aspects of a protocol are integrally intertwined with other elements of the trial, including study outcomes, sample size calculations, randomization procedures, and the timing and method of data collection. We work closely with sponsors to discuss reasonable estimates of treatment effects and variability with the clinical team and other stakeholders. When past clinical data are limited, Statistics Collaborative is able to use input from historical data and from subject matter experts to make data-informed protocol design decisions.

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 WCG’s endpoint adjudication and data monitoring safety committees, sponsors and CROs can benefit from a network of 700 members to enable more informed decision-making. Their expert reviews deliver reliable, trusted information to support critical decisions around clinical development programs.

Once a protocol is first drafted, or study protocol executed and complete, WCG’s experts are able to help Sponsors prepare for regulatory submission. Our statisticians at Statistics Collaborative have had considerable interaction with the FDA, including the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health. We are able to help sponsors prepare for early phase, End of Phase 2, and special meetings, in addition to Advisory Committees, with regulatory authorities where our statisticians may present on behalf of the sponsor. Our most senior, expert statisticians at Statistics Collaborative often participate in mock FDA panels where they play the role of FDA panelists. Sponsors can use such panels to evaluate and modify the written submissions and verbal presentations they have prepared for FDA panels regarding their trial protocols.

Maximize your investment: schedule a trial design and protocol planning consultation

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.