Expertise: Clinical Development 117 results
Milena Kanova-Petrova, M.D.
A comprehensive plan and the right regulatory and therapeutic expertise can significantly accelerate the development timeline and increase the likelihood of marketing success.
Accelerating Innovation Together
A 7-Step Roadmap for Operationalizing Large‑Scale Clinical Validation Studies
5 Tips for Designing and Operationalizing Natural History Studies
In the business of pharmaceutical and MedTech clinical development, the significance of robust data cannot be overstated. It serves as the cornerstone for informed decision-making and cultivates an environment where innovation thrives. However, when confronted with the task of comparing...
The Ascendance of Site Managers to Meet the Dynamic Needs of Clinical Research
The increasing complexity of clinical trials requires a re-assessment of the functions of site management and monitoring. Both roles have traditionally been the purview of clinical research associates (CRAs), who have typically spent 60%-80% of their time on monitoring and...
4 Steps to Implementing DEI in Clinical Trial Design and Patient Recruitment
Welcome to part two of our blog series focused on the integration of diversity, equity, and inclusion (DEI) into clinical research. If you missed part one of the series that highlights recent FDA initiatives and legislative changes behind these developments,...