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.

• Protocol design

  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.

• Statistical support

  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.

• Site selection

  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.

• Trial co-ordination

  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.

• Monitoring

  ICTU can provide international monitoring services for studies being co-ordinated by ICTU or as a stand-alone function.

• Data management

  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.