digital-clinicaltrials.com | Digital Data Requirements in Clinical Trials
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Course Overview

This course provides a practical understanding of data technologies used in clinical trials and is intended to provide attendees with the latest regulations, guidelines and requirements for using electronic data in clinical trials. With the recent widening of the guidelines and regulations to encompass electronic data, it is essential that all persons involved in any aspects of clinical trial data understand the principles and intent of the regulations. Companies must ensure that the QMS processes used in the management of clinical trials fully cover all areas of the regulations in relation to the management and integrity of clinical trial data.

This course provides a practical understanding of data technologies used in clinical trials and is intended to provide attendees with the latest regulations, guidelines and requirements for using electronic data in clinical trials. With the recent widening of the guidelines and regulations to encompass electronic data, it is essential that all persons involved in any aspects of clinical trial data understand the principles and intent of the regulations. Companies must ensure that the QMS processes used in the management of clinical trials fully cover all areas of the regulations in relation to the management and integrity of clinical trial data.
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Key Topics:

Global Regulations involving Electronic Systems in Clinical Trials

The Digital Revolution in Clinical Trials

EDC Requirements and Compliance

IRT Systems

EMR Systems

eCOA Systems

eConsent Systems

eTMF Systems

eLMS Systems

Audit Trails

Compliance Issues to electronic systems

Providers of Electronic Systems

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Trainer Profile

This course provides a practical understanding of data technologies used in clinical trials and is intended to provide attendees with the latest regulations, guidelines and requirements for using electronic data in clinical trials. With the recent widening of the guidelines and regulations to encompass electronic data, it is essential that all persons involved in any aspects of clinical trial data understand the principles and intent of the regulations. Companies must ensure that the QMS processes used in the management of clinical trials fully cover all areas of the regulations in relation to the management and integrity of clinical trial data.

Mark Poulton

Mark Poulton

Executive Director - Poulton Quality Solutions, UK
Former GCP Inspector - MHRA

Mark started his career in Pharmaceutical Discovery Research where he spent 17 years in a number of anti-infective programmes. Mark then moved into Clinical Research where he worked as a global Programme Manager working for a number of different pharmaceutical companies (British, French, American and Japanese) and has managed different trials in many therapeutic areas on a global basis. In this time Mark was involved in all aspects of research from drug development planning, management and reporting of trials and submitting trial data to authorities.

After 13 years in clinical research Mark moved to the MHRA, where he was a GCP Inspector and was involved in all aspects of GCP inspection in the UK and overseas. He was involved in the non-Commercial inspection process and also the bioequivalence inspection process. After 5 years as an inspector, Mark joined ADAMAS Consulting in October 2011 where he was involved in a number of different audit types in different areas of the world, having performed most aspects of GCP, laboratory aspects of GLP and IMP manufacturing aspects of GMP audits. In 2017, Mark moved back into the pharma industry by taking on the Senior Manager QA role at Clovis Oncology and in 2019 set up his own quality consultancy company Poulton Quality Solutions Ltd to provide global quality expertise and advice clients to ensure compliance and understanding of clinical requirements.

He has vast experience, not only in clinical trial management but also in clinical quality compliance and training. He has conducted in excess of 350 audits / inspections of clinical trials and systems and has performed in excess of 20 training courses covering most aspects of clinical trial quality and compliance. Mark has a degree in Applied Biology, specialising in Microbiology and is a member of Research Quality Assurance (RQA).

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Course Features

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Real-Life Case

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Renowned Trainers

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Certificate

Certificate of completion issued by the trainer

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Interactive sessions

Interactive sessions that go beyond traditional lectures

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Benefits

This course provides a practical understanding of data technologies used in clinical trials and is intended to provide attendees with the latest regulations, guidelines and requirements for using electronic data in clinical trials. With the recent widening of the guidelines and regulations to encompass electronic data, it is essential that all persons involved in any aspects of clinical trial data understand the principles and intent of the regulations. Companies must ensure that the QMS processes used in the management of clinical trials fully cover all areas of the regulations in relation to the management and integrity of clinical trial data.

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Course Price

This course provides a practical understanding of data technologies used in clinical trials and is intended to provide attendees with the latest regulations, guidelines and requirements for using electronic data in clinical trials. With the recent widening of the guidelines and regulations to encompass electronic data, it is essential that all persons involved in any aspects of clinical trial data understand the principles and intent of the regulations. Companies must ensure that the QMS processes used in the management of clinical trials fully cover all areas of the regulations in relation to the management and integrity of clinical trial data.

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