UK, December: Clintec International’s (Clintec) Head of Project Management, Craig Elliott, will be presenting on paradigm shifting changes that are taking place with the implementation of Risk Based Monitoring in Clinical Trials in a webinar on the 8th December hosted by Business Dialogue.
Clinical Trials generate copious quantities of data, not all of it useful. A well organised Project Management Office can utilise this data and turn it into “meaningful management information”. This approach offers 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.
Craig Elliott as Head of the Project Management Office at Clintec is 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 started 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 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.
Please find the presentation/recorded webinar here: http://www.clinical-outsourcing.com/clintec-webinar-access.html Password: Access@Clintec