Join Medilink and partner Afortiori Development for an in-person event which will be about planning ahead for clinical evidence and preparing adequately for this.
The event will cover:
- Part 1: Introduction to Commercial Clinical Development. What is a clinical development plan? Why do I need one?
- Part 2: Trials and trial design considerations , Regulatory requirements & guidelines, ethical considerations, trial set up, trial oversight, site selection, systems requirements
- Part 3: Trial oversight, patient recruitment, quality assurance, safety monitoring, trial data reporting
Key Objectives for attendees:
- Know what your Sponsor responsibilities are where a trial is concerned
- Be clear about what happens and when in planning and undertaking a clinical trial
- Identifying preliminary project timelines for any project and be able to see how various changes impact overall timelines
Speaker information
Dr. Nicola Wall, PhD and Chief Executive Officer at Afortiori Development Ltd
Nicola founded Afortiori Development to address the need for improved clinical trial design, planning and management to promote efficient and cost effective clinical trials. She has an exceptional background within the pharmaceutical, medical technology and healthcare sectors with over 20 years of diverse experience. She has managed multiple projects across a range of therapeutic areas for a number of large and small clients spanning all areas of clinical development including regulatory, data management, safety, quality and organisational effectiveness. Nicola has also managed global clinical trials in Oncology and Neurology with responsibility for 29 countries across the entire clinical trial process. She excels in strategic planning, process re-engineering, systems implementation and organisational design. She has also worked for a number of years as an independent consultant for the UK national health service working on hospital operational planning, business cases and ways to implement new models of care.
Nicola is passionate in her desire to work with highly motivated and respected peers in addressing unmet medical need. Nicola believes that integrity, transparency and efficiency combined with experience and motivation results in the most successful projects and clinical studies.
She attained all three of her degrees at the University of Manchester in the UK including her PhD in Economics that focused on patterns of innovation in the pharmaceutical Industry.
Liz Ralph, BSc and Chief Operating Officer at Afortiori Development Ltd
Liz has worked in a variety of roles in the industry for over 20 years across clinical operations groups in a global CRO environment. She has monitored and managed a large number of clinical trials in all phases, healthcare settings and a number of countries before moving to a quality, process and training role, which included experience of regulatory inspections. This allowed her to develop a sound and extensive knowledge base to foster a strong embedded quality culture with a focus on continual process innovation and effective training for those working in clinicaloperations roles.
Liz has additional valuable experience in patient perspectives of participation in clinical trials gained whilst working in a large UK Clinical Research Facility actively delivering hundreds of clinical studies across 2 hospital sites in a large UK teaching hospital. During this time she led in patient and public involvement in clinical research for the Facility and worked nationally as part of a UK wide patient and public involvement network which aimed to ensure that patient and carer voices are prominent in research delivery in the National Health Service in the UK.
Liz is committed to designing and delivering clinical research with the potential to add significant value to the lives of patients and their families by developing accessible treatments for unmet clinical need.
Helen Hunt, Assistant Programme Manager – Knowledge Mobilisation at Health Innovation West Midlands
Helen has worked for Health Innovation West Midlands for 8 years and previous to that she has worked as an operational manager in the NHS acute care setting for 16 years. During her tenure, she has undertaken multiple roles, starting with frontline patient-facing positions right up to senior management positions overseeing large departments. These positions have covered a large cross-section of NHS landscape including cancer services, operational management, health informatics and R&D. Helen is a trained Prince 2 practitioner, with her post graduate certification in Health Management specialising in Quality Improvement & Patient Safety. She is passionate about connecting people through knowledge mobilisation to allow real world evidence to be generated.
To read more about Medilink Midlands’ role within the WMHTIA project, click here.
For more information on the wider project, click here to visit the WMHTIA website.
This event forms part of the West Midlands Health Tech Innovation Accelerator (WMHTIA) event series. Medilink Midlands are one of a consortium of delivery partners for the WMHTIA, a project funded by the Department for Science, Innovation and Technology, Innovate UK and West Midlands Combined Authority (part of City Regions).
