Services » Study Design & Protocol Development

Integrium was founded by clinicians who understand not only the clinical research arena, but also the practical needs and priorities of practicing physicians. Today, Integrium continues to leverage this real-world clinical trial experience with our specialized cardiovascular and metabolic disease comprehension. This clinical expertise enables us to efficiently design studies and develop protocols that serve as the roadmap for our clients’ successes. Without such insight, protocols risk being developed in a way that is too academic for the practicing physician. However, clients can depend on Integrium to produce study designs that yield the type of information regulatory agencies, as well as practicing physicians, seek.

Integrium's experience also means we can perform this design and development process with a rapid turnaround time, while still addressing all the possible study challenges and GCP/ICH guidelines. Integrium’s team, including our medical officers, biostatisticians and medical writers, collaborate closely during this development process, making sure that the final outcome is reflective of clearly understood objectives. As a result of this collaborative process product approvals and market acceptance can be optimized from the start, avoiding common pitfalls that can otherwise cost clients valuable time and money.