GeoSera is a clinical research company specializing in designing and executing high-quality clinical trials. Contracting with GeoSera allows pharma and biotech companies to delegate oversight of their pipeline to experienced clinical research professionals who excel at leading phase I-IV clinical trials, entire Clinical Development Plans, and in-house and outsourced study teams. These experiences allow GeoSera a competitive edge because we help design and then execute clinical trials. GeoSera's Objectives -Embed our contractors or Functional Service Providers (FSPs) within pharma and biotech companies -Provide cost-effective drug development support and oversight to achieve positive trial outcomes within budget and timelines. -Create and execute Clinical Development Plans (CDPs) from initial regulatory communication to database lock to facilitate bringing treatment to patients. -Incorporate GeoSera’s experiences to identify potential CDP risks and create mitigation strategies to proactively implement solutions. -Develop protocols, ICFs, CSRs, IBs, and articles for regulatory submission. -Communicate and oversee executive management team decisions to outsourced vendors, in-house operational teams, CROs, and research sites. -Provide statistical support, power calculations and SAP creation/review. Connect with GeoSera's President and Owner, John Carlos Diaz: https://www.linkedin.com/in/johncarlosdiaz