We can take the sponsorship role but have flexibility
Particular areas of interest or experience in cardiovascular trial design and delivery
TCTU has extensive experience of successful cardiovascular trial design and delivery. We routinely provide pre-award support, managing the preparation of research bids for large multicentre drug trials and intervention studies as well as smaller, single-site trials. Support begins in depth from early in the evolution of the research question through to novel and innovative trial delivery approaches, development of patient pathways, recruitment strategies, sample size calculation and budget preparation including liaising with academic collaborators and third-party providers. Patient and public engagement is central to our activity and built into every application.
Dedicated, funded post-award support is available in three main areas: trial management, data management and statistical analysis. TCTU may be responsible for all aspects of trial delivery, data quality, analysis and dissemination or provide standalone packages, e.g. GCP-compliant data management system, randomisation and drug management system, interim and final analysis. TCTU also provides training and mentoring to early-stage researchers and clinical teams.
TCTU is keen to underpin a multidisciplinary approach to cardiovascular research and associated co-morbidities, including the identification of novel biomarkers and innovative treatment approaches, especially where no effective therapies currently exist. While supporting CTIMPs and complex intervention studies, we are also interested in supporting community-based research and have experience of a range of cardiovascular endpoints and imaging techniques. We also support early-stage researchers as well as established research teams. TCTU trial managers have developed a broad spectrum of cardiovascular trial protocols and patient-facing documentation, and successful recruitment strategies from a wide range of patient pathways.