Protocol Development and Study Design

Our teams are continuously working with our clinical trial sponsors to find creative ways to improve both the speed and efficiency of their clinical development programs. We take a risk-based approach to assessing protocol design and complete a critical review of the data collection measures, volume and method, patient pathway, and expected outcomes. We strive for quality delivery according to your timeline and will suggest alternative approaches based upon a thorough landscape review and strategies to support optimal study outcomes. Protocol optimization is available as a consulting service or can be requested as part of your overall regulatory or clinical trial execution strategy.

The global clinical research environment is rapidly evolving, making it essential to explore a digital strategy for remote engagement and data collection for all protocols. We will review the key elements of your protocol, such as endpoint data collection methods, schedule of events, vendor data requirements, patient burden, engagement, and retention. As part of this evaluation, our team will consider options for decentralized or hybrid design elements and make a recommendation in order to help guide you in making decisions that will boost the delivery of your clinical trial.