Study Design and Protocol Development
The blueprint to building successful Phase I, Phase II, Phase III and Phase IV projects
Study Designs
ARI’s scientific and regulatory affairs division will provide the sponsor with study designs aimed at specifically answering specific drug development objectives (e.g., First-in-man, rising dose safety/tolerance, BA/BE, drug-drug interactions, renal or hepatic impairment studies, thorough QT studies, proof of concept, global population PK/PD assessment).
ARI creates rigorous study designs to ensure that the approach proposed will meet the highest scientific, regulatory, and clinical requirements. Taking a proactive stance, our study design experts will schedule time to meet with your drug development staff to ensure that the proposed study design will be correct for your development needs.
Our study designs are provided in an expedited fashion in order to enable you to make a go/no go decision rapidly during the drug development program from a scientific, regulatory and also business perspective.
Protocol Development
The protocol development group at ARI has many years of experience in creating protocols that address the needs of sponsors. Our experience spans the drug development spectrum from first-in-man to Phase IV studies, single to multi-center trials. In addition, our protocol development experts will ensure that your study will be scientifically rigorous and meet regulatory requirements of the applicable jurisdictions (e.g., US FDA, Health Canada, EMEA).
To find out more about creating the best blueprint for your clinical study, please contact us.