Cathleen White
Pharmaceutical / Bio-tech
Services offered
Select and manage clinical sites participating in research studies to designed to assess a drug candidates' safety and effectiveness with the long-range goal of gaining NDA approval.
Manage projects and programs to assure on budget and on time completion.
Manage collaborative teams thru the drug approval process.
Experience
A highly experienced clinical research and operations professional with over 25 years of experience in the pharma, biotech and CRO industries. Having played a leadership role in the conduct of global clinical trials across multiple therapeutic areas, led to successful NDA submissions in CNS diseases and dermatology while simultaneously contributing to evidence-based research in oncology, cardiology and infectious disease. Demonstrated exceptional skill in building collaborations between the multiple partners, government, industry and academia that contribute to bringing any new drug to the marketplace.
As a former president of ACRP continues to be passionate about accurate and efficient delivery of data required to document a drug's safety and efficacy and to the continued professional development of the individuals who assure this work is conducted within ICH GCP guidelines.
Education
Bachelor's Degree from Western Michigan University,
Clinical Research Auditing Certificate
Good Clinical Practice:
2024: Information Privacy & Security for FHI 360
2024: GCP for Clinical Trials w Investigational Drug and Biologics (ICH focus)
2023: Good Clinical Practices Training
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