Carlos Estrada Email Address

Director, Clinical Quality Assurance

We focus on in-licensing innovative drug candidates that are undergoing or have already completed initial clinical testing for the treatment of various forms of cancer and then seek to further develop these drug candidates for commercial use.

Global pharmaceutical medical executive with strong background in clinical medicine, clinical trials, Quality assurance, global regulatory affairs and external engagement of healthcare stakeholders, government agencies and medical institutions in the US, Middle East, Europe and Latin America. I have over 20 years of experience in Clinical Trials, and over 16 years in FDA regulated industry. My expertise is in GCP Compliance, Clinical Auditing, Regulatory Inspection Management, Pharmacovigilance and Risk Management. I am a professional who shares a passion for the value a robust and vibrant pharmaceutical industry offers to patients Responsible for working with academic institutions and private pharmaceutical companies on issues like medical ethics & human rights, trial design and methodology offering scientific and technical knowledge. I have been internationally recognized as a GCP trainer, with experience in Clinical trials in the US, the Middle East and Latin America. I have been involved in FDA-regulated clinical research since 2004, and have worked with major Medical Centers as MD Anderson and Texas Heart Institute. I have also been involved as a Speaker and trainer with USAid and several organizations, as the Society of Quality Assurance. I am also have a certification as a Data Protection Officer (DPO). Specialties: • Clinical Trials: Phase I to Phase IV • Regulatory Alignment & Strategy • Safety and Risk Management • Investigator Initiated Research • Key Opinion Leader Interaction • Research Ethics & study design and methodology • Protocol and IB development • Clinical Trial Management. • Pre-inspection audits • Regulatory Inspection hosting and management • Clinical Site Audits • Clinical and Medical Monitoring • Regulatory Submissions (IND, NDA, sNDA, ANDA, BLA) • Vendor Audits • GxP Audits Areas Of Expertise: • Oncology Trials • Medical Devices • Surgery • Cardiovascular • Metabolic Disorders • Biologics