At Quintiles Outcome, we understand the intricacies of the product development and lifecycle of pharmaceuticals, and we know how to create a registry, peri, or post-approval program for your drug that will focus on safety, effectiveness, efficacy, value, and quality. Our experience in designing, developing, and managing pharmaceutical (drug-, disease-, or condition-focused) studies spans all therapeutic and medical practice areas.
Once your biotech drug or therapy achieves regulatory approval, your need for data doesn't stop, it just changes - and so do your audience and your objectives. We partner with biotechnology companies to create programs that help them continue the research they started in the pre-approval phase. We will work with you to implement a program that fulfills your specific needs, such as creating a competitive advantage, understanding the natural history of a disease, discovering new therapeutic indications, and evaluating safety and effectiveness.
Quintiles Outcome has significant experience in studying devices, including cardiovascular, endovascular, and neurovascular devices as well as devices for cancer detection. Through this experience, we have developed an understanding of the roles, benefits, and risks of medical devices, which has in turn honed our solutions to ensure successful device studies. We understand the market dynamics that differentiate devices from drugs, including short product life spans, competitive pressures, and constant innovation.
We pride ourselves on our ability to successfully form partnerships with medical associations, which gives our team the capacity to rapidly develop evidence about the device. We work with key opinion leaders and society leaders to develop programs that not only evaluate the clinical and cost effectiveness of medical devices, but actually enhance a practitioner’s ability to prescribe or implant the device in appropriate populations.