Protocol Development

Clinical Trial Protocol Design

The development of clear, scientifically sound clinical trial protocol design is critical for the execution of your research. It’s essential to gain as much information from early phase clinical trials as possible to make faster, more informed go/no-go decisions. Our strategic focus on applied translational medicine maximizes the amount of information gathered from one study and reduces your overall costs, without jeopardizing the integrity of your primary and secondary objectives.

We have a dedicated team of highly skilled, multidisciplinary protocol-development scientists with expertise in clinical pharmacology, pharmacokinetics and a diverse range of therapeutic areas. They work with our team of clinical, medical, and bioanalytical experts, biostatisticians, and drug development scientists to develop and deliver high-quality protocols for early phase clinical trials, covering a wide variety of dosage forms and study designs. We leverage the available preclinical data to guide us in designing studies that reduce time from first-in-human to clinical proof-of-concept.

Our highly skilled team of scientists has the expertise to create efficient, cutting-edge adaptive and fusion study designs across populations to integrate safety, pharmacokinetics (PK), and pharmacodynamics (PD) that are traditionally evaluated in multiple studies. For example, by adding a patient component to an ascending dose study, PK and PD activity can be evaluated in the target population early in the drug development stage, providing preliminary findings on the efficacy of the compound. Similarly, adding Holter monitoring in ascending dose cohorts offers insights into cardiac safety and potential liabilities, enabling early concentration-QT analysis and the exploration of common cardiodynamic endpoints. Study designs linking PK and PD endpoints provide essential data to make robust dose level decisions for later phase studies.

Experienced in the ethical and regulatory requirements of North America, Europe and Asia, we offer a global solution to your protocol development needs, from conceptualization to development, providing consulting services as well as comments and direction on strategies for Phase I, IIa, and NDA-enabling clinical pharmacology studies.