Challenging the Status Quo: The Diffusion of Technology in Study Startup

Challenging the Status Quo: The Diffusion of Technology in Study Startup

Technology as a catalyst for change

Study startup time, widely considered a leading cause of lengthy cycle times, has stagnated for twenty years. Research from the Tufts Center for the Study of Drug Development indicated that clinical operations teams "satisfied" with their processes and those outperforming their competitors were adopters of technology.

Difficult decisions are the privilege of rank, as such leaders must be prepared to challenge the status quo of manual systems inherently used for study startup.

But what is the extent of this technology adoption in site collaboration? And is this adoption serving as a catalyst for other organizational changes, such as interdepartmental collaboration (i.e., breaking down silos) or outsourcing oversight? Or are organizations simply "automating" manual processes without realizing the true operational benefits that technology can bring?

ISR Reports presents the findings of a new study accessing the diffusion of eClinical technology, the effectiveness of those technologies, perceived barriers and change management, with a focus on site selection and activation in starting clinical trials.

In this webinar, we will explore:

  • eClinical technology adoption in study startup
  • Discussion on site engagements and performance evaluations
  • Challenges, barriers and opportunities involved in study startup related to processes, existing technology, data sharing, and operational transparency
  • Aspects associated with change management and assessment of technology deployments

This webinar is applicable to:

  • Sponsor and CRO roles responsible for site identification, feasibility assessment, selection and activation
  • Sponsor and CRO roles responsible for collecting trial documentation
  • Sponsor and CRO roles responsible for regulatory and ethical study approvals
  • Sponsor and CRO roles responsible for project management of studies and operational excellence


Andrew Schafer
Andrew is responsible for directing syndicated research products, custom market research efforts, and strategic planning. Prior to ISR, at Quintiles he was responsible for primary market research activities, leading strategy, functional service provider, and market development activities for data management and biostatistics, corporate new service introduction, and led the North American Corporate Strategy function. Andrew received undergraduate degrees in Finance and Economics and an MBA in Marketing and Statistics from Syracuse University.
Industry Standard Research
Rob has been a computer scientist and programmer for over 30 years in the scientific programming, e-commerce, biotech, and health care industries. He implemented study startup and CTMS functionality at 9 bay area biotech companies and invented a method that allows medical and biotech organizations to use cloud-based analytics to monitor patient data. He holds a BS in Computer Engineering from Sacramento State University and a PhD in Biological and Biomedical Clinical Informatics from UCSF.
VP Technology
Rob Wynden

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