Accelerated Start-Up: The Right Start to Trial Success

In the early stages of a clinical study, getting off to the right start is critical. Yet, up to 70% of clinical trials experience study start up delays, and almost half are completed late. Each day a timeline slips can keep new products from patients and put millions in future revenue at risk.

The highest levels of efficiency can be realized by implementing experienced-based and mutually agreed-upon site identification and selection strategies, by leveraging customized templates, processes and technologies, and by leveraging a highly dedicated regulatory start-up team. This will accelerate the study start-up process, reaching the goal of sites initiated and ready for enrollment as quickly as possible.

In this webinar, we will demonstrate how the following strategies, processes, and technology help maximize productivity and reduce cycle times.

• Leveraging customized forms, pre-translated into 60+ languages that include country-specific legal requirements in protected templates;
• Preparing for site selection by applying electronic Site Information Forms (eSIFs), and optimizing the contracting process by using our Clinical Trial Agreement (CTA) template and predefined negotiation terms and robust budget negotiation parameters;
• Using our core Informed Consent Form (ICF) template, which incorporates all GCP and country-specific elements that are pre- translated;
• Utilizing Quintiles Infosario Site Gateway and Infosario Analytics to help ensure that technology underpins streamlined communication and document exchange, giving sites access to better progress reporting and earlier identification of risk indicators.

We will also discuss how we are using an industry-leading approach, supporting sponsors with Fair Market Value (FMV) compensation analysis to ensure compliance with Anti-Bribery / Anti-Corruption (ABAC) compliance.

Speakers

Wendy Stewart, Vice President, Integrated Site Start Up, Quintiles

Wendy Stewart is Vice President of Integrated Site Services with Quintiles and is responsible for Global Regulatory Start Up, leading a team of regulatory start up experts. With over 18 years healthcare experience, Wendy has held positions in Singapore, North America and the UK and is experienced in all phases of clinical development and central laboratories. She has successfully led enterprise wide strategic initiatives centering on technology implementations coupled with defining and implementing the associated change management and adoption strategies. Wendy currently sits on a number of Executive Steering Committees in support of several customer and partner relationships.

Wendy holds a Bachelor of Science degree in Biological Sciences and worked as a reproductive biology scientist for the Medical Research Council prior to joining Quintiles.

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Sam Searcy, Associate Contracts Services Director, Global Regulatory Start Up, Quintiles

Sam Searcy operates the Quintiles global fair market value program including the Quintiles site fee committee within the Global Investigator Contract Solutions department, a part of Integrated Site Services. Sam is responsible for ensuring corporate compliance with fair market value matters in order to mitigate global bribery and corruption risk. His role lies at the intersection of study start-up, ethics & compliance and legal.

Prior to joining Quintiles, Sam was based outside London and managed the investigator site contracts department in Europe and Asia-Pacific for a global CRO.

Sam is a licensed attorney and holds a Bachelor of Science degree in Political Science and English from Appalachian State University and a Juris Doctor degree from the University of Tulsa.

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