David Skarinsky serves as an Independent Consultant/Contractor at Apotheca Biosolutions, LLC, where he leverages his extensive expertise in strategic development and regulatory strategy to enhance clinical programs across multiple therapeutic areas. With a robust background in Phase I-IV multinational development, David excels in orchestrating complex...
David Skarinsky serves as an Independent Consultant/Contractor at Apotheca Biosolutions, LLC, where he leverages his extensive expertise in strategic development and regulatory strategy to enhance clinical programs across multiple therapeutic areas. With a robust background in Phase I-IV multinational development, David excels in orchestrating complex clinical operations while ensuring compliance with Good Clinical Practice (GCP) standards. His role encompasses a wide array of responsibilities, including feasibility assessments, risk management, and the formulation of global regulatory affairs strategies that are critical for the successful navigation of the pharmaceutical landscape.
Currently, David is spearheading key projects that involve comprehensive clinical consulting services, focusing on optimizing global clinical operations. His proficiency in CRO and vendor selection, along with oversight of site selection and start-up services, has proven invaluable in streamlining processes and enhancing operational efficiency. David’s commitment to quality systems and process development is evident in his approach to interim analysis support and study close-out services, where he ensures that all clinical trials are executed with precision and adherence to regulatory requirements.
In addition to his operational prowess, David is adept at technical writing and data management, skills that are essential for the effective communication of complex clinical data. His ability to lead cross-functional teams and manage projects from inception to completion makes him a vital asset to any organization in the life sciences sector. As he continues to contribute to the advancement of clinical research, David remains dedicated to fostering innovation and excellence in pharmaceutical development.
