Clinical trials in the diabetes space offer a number of unique challenges. Selecting inclusion and exclusion criteria that are overly strict or loose runs the risk of targeting the wrong patients and adversely impacting patient enrollment. Likewise, a small error in the calculation of exposure and event rates can have a significantly negative impact on estimation of the number of patients needed and the study timeline.
This diabetes webinar will provide an overview of advanced data mining and software applications that can be used to understand the implications of various protocol entrance criteria. Specifically, the webinar will highlight the impact of key protocol design elements on event rates and exposure rates by:
- Demonstrating how virtual population simulation technology provides externally validated benchmarks for patient profiles and event rates
- Examining how predictive software can be used to calculate expected dates for reaching event and drug exposure targets for your diabetes trial
- Discussing a case study applying these techniques to diabetes protocol design
This webinar is designed to help you gain a better understanding of how to use existing data and predictive software to target optimal patients and improve forecasting of expected timelines and events. Utilizing these predictive techniques during study planning may help reduce the need for protocol amendments and ultimately, help you get the right diabetes drug to the right patients as quickly as possible.
Mauro Martinelli, Emerging Markets Specialist, Quintiles
Mauro Martinelli has a biochemist degree from the “Universdidad de Buenos Aires and has more than 14 years of experience in Clinical Research. Since 2006, Mauro has been working with global and local customers to include Latin America as part of global studies.
Based in Washington DC since 2009, his main focus has been detailed information on Latin America in relation to therapeutic focus, regulatory environment and resulting requirements, local policies, available patient profiles, as well as providing recommendations on country selection for specific clinical trials. Depending on the study objective, Mauro could successfully assist companies based in US or EU to include Latin America in their global studies, or work directly with Latin America based companies to set-up their local study in the most efficient way.
Previous to his current position, Mauro worked over six years in Clinical Operations for Quintiles, based in Buenos Aires, Argentina. During this time, he covered activities from monitoring to study management (Phase IIb, III and IIIb) across US, Latin America and Europe.
Jose Emilio, Associate Director, Clinical Operations, Quintiles
With 13 years of experience in Academic and Clinical Research in Pharmaceutical companies and CRO across the Latin America region, Jose Emilio, Associate Director, Clinical Operations, is responsible for:
- Clinical Operations Management – Direct clinical monitoring group management to ensure projects are appropriately resourced and employees are trained and developed to meet project needs within high quality standards.
- Customer and Project Management – Analysis of company and clients strategy including pipeline, programs review, direct control of the delivery against key metrics, scope of work, budget, quality of deliverables following Good Clinical Practices, ICH Guidelines and all applicable local regulations.
- Wide experience in various functions such as CRA, Clinical Team Lead, Clinical Operations Manager, Project Manager and Site Identification group Manager across the Latin America region.
- People management – performance, coaching, actions plan and general support for staff development.
Who Should Attend?
Senior level executives from pharma/biotech companies involved in:
- Clinical Research
- Outsourcing / Procurement
- Clinical Operations
- Regulatory Affairs
- Project Management
Quintiles is the only fully integrated bioPharmaceutical services company offering comprehensive solutions worldwide across the product lifecycle. Our network of more than 27,000 professionals in 100 countries has an eye on the future while delivering results today with an unwavering commitment to patients, safety and ethics. Quintiles helps bioPharmaceutical companies develop and commercialize products to improve and lengthen patients’ lives while demonstrating value to stakeholders.
As a pioneer in bioPharmaceutical services, Quintiles has helped develop or commercialize all of the top 50 best-selling drugs during our 30 years of experience. We have supported over 80 product launches in the US, including 25 companies who were launching a product for the first time. The benefits of our partnership model include retention of strategic control, long term value maximization, operational risk management, and corporate and operational flexibility, and hence offers an attractive alternative to traditional co-promotion and out-licensing approaches.
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