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ACDM19 Speaker Details

Rob Nichols

Rob Nichols



As part of high performing management teams in growing companies Rob has applied strong leadership and communication skills to define and convert large-scale strategic objectives into commercially successful outcomes across diverse regions including USA, Japan, India, China and Europe. Rob has repeatedly been part of teams assessing future industry requirements, leading to the driving of novel approaches, resulting in wide scale uptake in a variety of what have become mainstream eClinical offerings – including eDC at Phase Forward, eSource at IQVIA, and Risk Based Approaches at Algorics. Rob has presented at numerous global data management conferences over the last 20 years, including presentations at SCDM, DIA and OCT among others. Rob has also served as chair of the ACDM

Title of Session: Making the patient the centre of clinical research

Description of Session:

Clinical research is going through its moment of rapid digitisation, across all phases of drug development. With increasing focus on phase 4 and RWE comes the need to capture more data and at a higher level of quality from patients. The problem is: How to engage patients effectively and at scale, while managing spiralling costs and ensuring validation and control.

We have employed a BYOD SaaS platform at scale in multiple large-scale direct to patient and site-based studies. We will show that engaging study participants through a patient centric application and clinically validated platform results in greater engagement and rates of data capture.

We will share results from a number of trials including 100 for Parkinson’s, Cloudy with a chance of pain and further anonymised studies to demonstrate how high-quality sensor, PRO and EMR data can be combined to create the next generation of data management platform. Potentially extending the data capture window for trials pre and post study period, giving greater insight and enhancing the patient experience. The role of the data manager will need to adapt to a changing world where there is a continuum of research moving from the clinical trials through into the Real World.

Learning Objectives:

Enabling patients to use their own smart device (Bring Your Own Device) and its built-in user interfaces, sensors, and connections to other devices will have the biggest impact for clinical data capture

How the role of the data manager is shifting as we move to greater patient engagement through participant level eSource

How to make large-scale, non-interventional direct-to-patient studies, feasible and engaging

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