ABOUT US
Who we are?
At the heart of our company is David Edghill, a seasoned expert with over 25 years of experience in Clinical Data Management across a diverse range of biotechnology, pharmaceutical, and device companies. David's career spans from his early days at Allergan Inc., where he played a pivotal role in the development of the FDA-approved Restasis (Dry Eye). His journey through the phases of clinical trials has endowed him with a comprehensive understanding of study start-ups, study conduct, and study closure within the realm of Clinical Data Management.
In addition to his core competencies, David possesses an acute understanding of the intricacies involved in not just collecting clinical trial data from electronic Case Report Forms (eCRFs) in an Electronic Data Capture (EDC) database, but also in handling external data types such as Pharmacokinetic, Pharmacodynamic, Biomarker, etc. His proficiency extends to the nuanced management of these complex datasets, ensuring their accuracy and integrity of the data.
David's expertise is not just limited to the technicalities of data management; he has a profound knack for managing all data project components, including study budgets, research for proposals, CRO vendor performance, and personnel management. His insights into Good Clinical Data Management (GCDM) practices are invaluable at any stage of a study, be it Phase I, II, or III.
But what truly sets David apart is his ability to demystify the complexities of current technologies such as Electronic Data Capture (EDC), Randomization and Trial Supply Management (RTSM), Electronic-patient-reported outcomes (ePRO), and Electronic Clinical Outcome Assessment (eCOA). He excels in translating these technical aspects into understandable language for diverse teams, advising on the best systems and methodologies for each unique clinical trial.
David's collaborative skills are exceptional. He has a proven track record of working seamlessly with various arms of a clinical research team, including Clinical Operations, Regulatory, Biostatistics, and Preclinical Sciences. His focus on clear communication and emotional intelligence fosters a cohesive understanding of Clinical Data Management needs, making him a respected leader in the industry.
Beyond his professional acumen, David is an individual with a deep commitment to lifelong learning and excellence. He holds a bachelor's degree in business administration and Spanish from Jacksonville University (1991) and later advanced his education with a Master of Science in Health Sciences, concentrating on Clinical Research, from George Washington University (2015). This educational background, combined with his vast experience, positions David not just as an expert but as a visionary in Clinical Data Management.
His vision and leadership are the cornerstones upon which our company is built, and they guide us in our mission to deliver unparalleled service to our clients.