In this eClinical Forum webinar presentation, Dr. Jules Mitchel, President of Target Health, facilitated the discussion on the future landscape and regulatory concerns of paperless clinical trials and clinical trial design incorporating mobile tools.
Dr. Jules Mitchel, President of Target Health, delivered this presentation on the new FDA Guidance on the use of the electronic health record for clinical research at the North American eClinical Forum Autumn Meeting on October 2, 2018.
This DIA 2017 presentation by Dr. Jules Mitchel provides an overview of paperless clinical trials and the tangible benefits that electonic source data (eSource) provides to Sites, Patients, Sponsors, and Regulators.
Now that paper records are disappearing from the clinical trial landscape, functionalities of the clinical trial enterprise should be easily available at one website and with one login. While documents can sit in the trial master file (TMF), access to the EDC system should be seamless from the time that the patient electronically signs the informed consent form (eICF).
Various metrics that have been achieved using eSource enabled by Target Health
From CBI Conference, March 2015: Impact of Risk-Based Monitoring and eSource Methodologies on Clinical Sites, Patients, Regulators and Sponsors
Working with FDA: How creative one can be when working with FDA to optimize the drug and device development process.
Avoiding resistance and inefficiencies when there are new ideas and new opportunities, and experience from the real world.
Experience from Phase 3 Study Using Risk-Based Monitoring and eSource
Slides from Society for Clinical Trials, The goal of this CTTI-sponsored project was to describe current clinical monitoring methods for a range of clinical trial types, and to explore the rationale for the use of those methods.
