PatchwoRx Technology Ventures, LLC, provides consulting services to the pharmaceutical and biotechnology industries. We focus on helping organizations successfully address their strategic challenges by developing innovative approaches in designing clinical and regulatory strategy. Our expertise in clinical design in multiple therapeutic areas and our history of positive interactions with the FDA is key to our ability to implement the strategic thinking and careful planning for your drug development programs.
Clinical
PatchwoRx has extensive experience in multiple therapeutic areas. Designing clinical trials requires an understanding of the disease and/or the disease process. Clinical experience with the condition of interest to the client makes for better trial design, yielding interpretable data in a timely and economic fashion. Trial design that yields clearly delineated outcome variables that answer specific questions in an unambiguous fashion, saves time and money for our clients. The results of each trial should support the overall strategy for the drug development program
Regulatory
PatchwoRx has a successful track record in its interactions with the FDA. This stems from our history of partnering with the FDA, through a willingness to understand and communicate while representing the best interests of our clients. PatchwoRx has extensive experience with various divisions of the FDA, and these interactions include:
· FDA meeting, planning, preparation, and presentation
· Advisory meeting support
· Dispute resolution
· Post-meeting issue analysis and response
· SAE reporting strategy and FDA concurrence
