Study Design

Our Adaptive Delivery process draws on our customized approach to study design and conduct, especially for novel therapies.

Adaptive Delivery: our exclusive methodology for clinical trials

Expect the unexpected

Adaptive Delivery is our exclusive methodology for running clinical trials. This systematic strategy unites your team and ours to focus on your molecule and established endpoints, and to coordinate staged feedback and updates throughout the trial. Leading the process is a single, highly accountable Premier Research account executive who maintains total project oversight, allowing you to remain focused on the science.

While every trial is different, all are stunningly complex and expensive to execute. Adaptive Delivery orchestrates the many pieces to make things happen when they’re supposed to happen, and devise effective solutions when things change. And things always change.

What’s more, in the biotech space, we’ve seen that customers can regularly face situations outside of their control, from pressing FDA inquiries to emergency board meetings to ongoing discussions with potential collaborators and new investors. Adaptive Delivery can accommodate all of these potential circumstances.

PREMIER PERSPECTIVE

Decentralized clinical trials

Pandemic-related disruptions have created a proving ground for decentralized clinical trials. The FDA and EMA have demonstrated a willingness to work with sponsors on developing study designs, but there is very little concrete guidance. Learn how to navigate the challenges here.

Adaptive design methods

By utilizing accumulating data to modify the operating characteristics of an active trial in accordance with pre-specified rules, adaptive designs can make clinical trials more flexible, efficient, and informative than fixed-sample designs. Adaptive design approaches can be applied across all phases of clinical development, including early oncology studies.

Related Services

Study design is part of a wide range of service offerings that include regulatory consulting, medical writing, and data management. Follow the links below to learn more about how clients gain from our specialized expertise.