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Will Decentralized Clinical Trials Compound Patient and Data Quality Risks?

Craig Morgan
Head of Marketing, Study Startup

Decentralized Clinical Trials (DCTs) offer a more patient-centric approach in which fewer clinic visits are required and patient and caregiver burden are reduced. DCTs utilize a wide range of digital technologies to collect safety and efficacy data from study participants, normally remotely from the patient’s own home.

With the introduction of a DCT, a significant element of patient engagement is moved away from a controlled (physical) investigator and site environment, which will present significant patient and data quality risks. Additional burdens incurred by adopting this technical infrastructure include, but at not limited to; system validation, creation of patient application training materials and patient training, and study setup and configuration prior to activation/enrollment.

This webcast will focus on understanding these risks and how they can be mitigated.

Please join us for this webcast:

Live: Tuesday, October 29, 2019

1pm EDT | 12pm CDT | 10am PDT

On Demand: available after airing until October 29, 2020

Register here.

This webcast will explore:

  • The perceived impact of DCTs on investigative sites, studies, staff roles and patients
  • The perceived benefits of DCTs on conducting studies, including additional burdens inherent in this new technical infrastructure
  • The challenges cited to DCTs in terms of adoption by the industry
  • The additional quality management elements required to mitigate patient and data quality risks resulting from DCTs.
  • The future of DCTs and the reality facing stakeholders continuing to conduct clinical trials in an industry embracing technology

This webcast is applicable to:

  • Investigative sites engaged or wishing to engage in clinical studies
  • Sponsor and CRO roles responsible for quality management
  • Sponsor and CRO roles responsible for application validation and deployment
  • Sponsor and CRO roles responsible for site identification, feasibility assessment, selection and activation
  • Sponsor and CRO roles responsible for project management of studies and operational excellence

Panelists:

DENNIS SALOTTI, Chief Operations Officer, The Avoca Group

Dennis Salotti is COO of The Avoca Group. With 18 years in the pharmaceutical industry as a sponsor, provider, and consultant, Dennis has experience that spans preclinical research, clinical operations, data management, quality assurance, eClinical, business operations and strategic management. Prior to joining The Avoca Group, Dennis was Director of Operations for WriteResult, an eCOA provider, where he was responsible for client delivery across the portfolio of global clinical trials. He has previously held positions in research and clinical operations for Pfizer and Merck. Dennis is an Adjunct faculty instructor for Drexel University College of Medicine’s graduate program in Clinical Research Organization Management. His educational credentials include an MS in Clinical Research Organization Management from Drexel University, an MBA in Technology Management from the New Jersey Institute of Technology, and a BS in Biology from Sacred Heart University.

 

BARRY MILTON, Executive Director - Head of Horizon, Novartis

Barry has over 30 years’ experience in the healthcare industry as a clinical trial and operations management expert. His experiences as an Oncology nurse, clinical trial coordinator and his senior management roles at Novartis, Roche, Merck, and AstraZeneca provides him with a well-rounded set of skills and experiences in the program management and clinical trial space. A focus on driving sponsor and site teams to meet their patient and clinical program goals faster and more efficiently drives his passion for process and execution excellence. Having led multiple process optimization projects and systems implementations he has a unique view of the business and end user needs.

 

ELVIN THALUND, Director, Industry Strategy, Oracle Health Sciences

Elvin is a recognized industry expert in clinical trials, having over twenty years of experience working as a Clinical Business Analyst Consultant at major pharmaceutical companies including, Hoffmann-La Roche and Johnson & Johnson. Elvin works as a product strategist and system architect in Oracle Health Sciences effort to optimize study startup. Elvin is the co-chair on the TMF Reference Model Exchange Mechanism and holds a Master of Science in Industrial Engineering from Aalborg Universitet.

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