IPSUM - Founder & CEO of IPSUM
Michael got his start working for Accenture in their pharmaceutical practice in the 90’s. With a focus on regulatory publishing, Michael later went to work as the CTO for a submission publishing startup called ESPS. Five years later, ESPS had a dominant market share in pharmaceutical publishing and exited with a successful IPO.
IPSUM applies the depth of our service offerings along with extensive therapeutic and analytical expertise to help our clients navigate the increasingly complex healthcare environment.
We work with biopharmaceutical companies with services and solutions that increase their probability of success, connecting insights with greater delivery for improved results.
Ipsum provides a range of services for pharmaceutical and medical device development. Our practice is broken down into three main areas.
Site Management Services
IPSUM is a leading SMO with local expertise covering patient recruitment, trial preparation, management and patient retention.
We recruit and retain more engaged patients, at fewer sites, and in less time than conventional trial sites, augmenting the quality and efficiency of our customers’ drug development pipeline. We have learned that, by engaging fully with patients, our clinical trials can be conducted more successfully and, in consequence, patient retention increases considerably. And because our clinical trial model is carefully applied throughout sites, we can offer clients consistent trials in all the country. One contract with IPSUM leads to large-scale patient recruitment with multiple sites to simplify trial management strategies.
Clinical Research Services
Our main services are:
• Feasibility Studies
• Project Planning
• Clinical Plan Development
• Site Identification and Assessment
• Regulatory Affairs
• Coordination of Investigational Sites
• Clinical Monitoring
• Medical Monitoring
• Quality Assurance
• Management of drug and laboratory samples
• Registration of new products / indications
Validated Software Development:
The U.S. Food and Drug Administration (FDA) and other international agencies require that computer software infrastructure and applications are appropriately tested for their regulated uses. Validation provides the required documented evidence through a process of planning, requirements definition, test development, test execution and final reporting.