ICTU can provide full support to Sponsors in managing a clinical trial from conception to communication
Defining unmet medical need
Drawing on the world-class experience of clinicians across Imperial College, ICTU can provide fresh insight to identify the true unmet medical needs in a specific disease area and examine where the greatest potential for new compounds lies.
ICTU’s approach to evolving protocol design aims to ensure that the protocol can be easily integrated into NHS procedures to optimise recruitment and that trial outcomes are scientifically robust and clinically relevant.
ICTU’s statistical teams can design the trial statistical plan and advise on novel methodologies required for more complex studies where required as well as provide statistical oversight throughout the trial.
Through our investigator network, ICTU can identify and sites with a proven track record of effective patient recruitment in a given therapeutic area and explore the feasibility of studies in related areas.
Chief Investigator role
The combination of clinical experience, academic leadership and extensive trial experience means that Imperial College lead clinicians are ideally placed to function as effective Chief Investigators throughout a trial and are highly committed to swift analysis and dissemination of trial results in leading journals.
ICTU can manage all aspects of trial co-ordination from site set up through to study close out, including risk analysis, set up and management of data safety/steering committees, full project management and tailored recruitment support.
ICTU can provide international monitoring services for studies being co-ordinated by ICTU or as a stand-alone function.
ICTU’s in-house electronic data management system uses Oracle’s InFORM platform, which is a highly secure system permits data validation at the point of input, live data monitoring and rapid resolution of queries. Our in-house team builds, tests and manages the system from initial trial design to data lock and completion.
Publication and dissemination of results
Imperial College is committed to the analysis and clear communication of trial results in high calibre journals. ICTU can provide therapeutic area training and other support to investigators throughout the study as well as lead on a range of post-study communication activities such as congress presentations, advisory boards, medical education initiatives and in-house medical training.
Direct access to expertise and ongoing research at Imperial facilitates the innovative integration of scientific expertise into clinical trial design. This enables ICTU to design and execute early phase studies which provide valuable insight into pharmacodynamic impact of compounds and access innovative tools to characterise target patient populations.
Imperial College London is ranked fourth in the world for Clinical, Preclinical and Health*. Imperial’s academic staff include world-leading clinicians and researchers across a range of therapeutic areas who due to their expertise are represented on national, European and international guideline groups that shape clinical practice.
* Times Higher Education world education rankings 2015
The impact of academic networks in providing leadership and translating advancements in knowledge into changes in medical practice cannot be underestimated. Equally, the impact of academically-led publications in influencing opinion and guidelines continues to be demonstrated in all areas of medicine. In addition, ICTU benefits from close links with a range of campus-based groups involved in specialised aspects of research, including imaging, biomedical research, translational and experimental medicine, public-patient engagement and design of diagnostic devices