David Alan Karlin serves as the President of BioPharmDoc Contract Services, where he leverages his extensive expertise in drug development to guide biopharmaceutical companies through the complex landscape of clinical trials and regulatory submissions. With a robust background in strategic planning from Phase I to...
David Alan Karlin serves as the President of BioPharmDoc Contract Services, where he leverages his extensive expertise in drug development to guide biopharmaceutical companies through the complex landscape of clinical trials and regulatory submissions. With a robust background in strategic planning from Phase I to New Drug Application (NDA) or Common Technical Document (CTD), David plays a pivotal role in shaping the drug development journey for his clients. His proficiency in Investigational New Drug (IND) preparation ensures that projects are not only compliant with U.S. Food and Drug Administration (FDA) regulations but also positioned for success in the competitive biopharmaceutical market.
At BioPharmDoc, David leads key projects that encompass the design, implementation, and analysis of Phase I-IV clinical trials. His hands-on approach to medical monitoring and clinical trial enrollment rescue has proven invaluable, particularly in challenging scenarios where patient recruitment is critical to maintaining project timelines. David's commitment to medical safety is evident in his meticulous review of serious and non-serious adverse events, ensuring that all safety data is accurately reported and interpreted for regulatory authorities.
In addition to his strategic oversight, David is adept at utilizing Clinical Trial Management Systems (CTMS) and crafting comprehensive protocols that align with regulatory expectations. His expertise in medical writing further enhances the quality of submissions, providing clarity and precision in documentation that is essential for successful regulatory interactions. Under David's leadership, BioPharmDoc Contract Services continues to excel in delivering innovative solutions that drive drug development forward, making a significant impact in the biopharmaceutical industry.
