Clinical Study Guidance

Investigator-Initiated Studies

The Yale Cardiovascular Research Group (YCRG) partners with selected Yale faculty to design, secure funding for, and execute single- and multicenter investigator-initiated studies on a range of topics in cardiovascular medicine. These collaborations leverage YCRG’s clinical trials capabilities with the research interests and expertise of Yale investigators to support Yale faculty and advance our academic mission.

Clinical Study Design and Regulatory Strategy

YCRG excels at the complete clinical trial development process, from clinical strategy need to execution. Clinically focused, operationally efficient, and scientifically forward-looking trial designs are the foundation of a successful clinical evidence generation program. Clinical data from YCRG-designed trials have provided the basis for market approval of numerous products, and advanced the methodology of cardiovascular clinical trials.

Biostatistics

The group provides expert statistical leadership for academic and industry-sponsored clinical trials and related projects. YCRG statisticians have experience executing the entire lifecycle of a clinical study, from study design and sample size calculations to statistical analysis plans, final analysis and interpretation, and statistical support for regulatory submissions/interactions and publications.

Trial Documentation and Medical Writing

The Yale Cardiovascular Research Group (YCRG) provides comprehensive medical writing, editing, and literature research to support all stages of technology development and all phases of clinical trial design and dissemination, including clinical trial protocols, literature reviews and meta-analyses, clinical study reports, regulatory submissions and reports, and peer-reviewed manuscripts.

Global Project Management

Modern clinical trials involve diverse collaborators and stakeholders and often span multiple geographic regions. While traditional project management focuses on day-to-day operational concerns, YCRG has found success augmenting trial leadership with dedicated high-level staff to ensure that all elements of study execution are focused on the academic and commercial end products, from trial conception to study closeout.