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Clinical Outsourcing Strategies

 

7 December 2016, 10.30 am CET

 

Webinar Title: A paradigm shift in Risk Management subject to Information-Based Decision

 

 

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7 December 2016, 10.30 am CET

 

 

A paradigm shift in Risk Management subject to Information-Based Decision

 

Clinical Trials generate copious quantities of data, not all or it useful. A well organised Project Management Office can utilise this data and turn it into “meaningful management information”. This approach offer solutions to engage and stream data, whilst offering a tailored solution to each project. Therefore, in order to place preventative measures and ensure risk is prudently calculated for, ClinTec suggests a new paradigm: where Data is used as ‘working information’ for decisions.

This is essential with the changes proposed by ICH GCP E6 and a risk based approach to clinical trials. A practical model is provided where early stage risk management is in-built to reduce erosion from trial objective. It is therefore recommended to ensure such processes are used to define the management of risk at the protocol, country and finally at the study level of a clinical trial.

Speaker Bio

 

Craig Elliott, Head of Project Management Office, ClinTec International

 

 

Head of the Project Management Office at ClinTec International responsible for turning data into “meaningful management information”. Following a degree in Physiology and a PhD in Respiratory and Exercise Physiology at Newcastle University, he stated life in the pharmaceutical industry as a CRA at Wyeth. He has 25 years experience within the industry, working within numerous global clinical operation functions, performance management and process improvement groups in both large pharmaceutical and medium CROs companies. He has a special interest in risk based monitoring, quality improvement and performance management.

 

ClinTec International

ClinTec International is an innovative, mid-sized, full-service global Contract Research Organisation and Functional Service Provider specialising in Oncology and Rare Diseases. With a local presence in over 50 countries, ClinTec has built a world-class team of permanent employees and country management delivering a high-quality, customer-centric service.

As an entrepreneurial and award winning business, ClinTec is at the forefront of conducting clinical research programmes worldwide, including unique access to emerging markets such as Turkey, Middle East and Africa.

ClinTec customises each engagement through a consultative and flexible approach, aligning every solution and service to the client’s individual requirements.