In diabetes studies, there is a complex interaction between dietary intake, physical activity, current diabetes status and medication regimen that makes diabetic-related results difficult to interpret. In addition, different treatment plans are required for type 1 versus type 2 diabetes as well as addressing the inherent disease heterogeneity. As a result, your study design and target patient population will differ depending on the type of diabetes and the drug or device purpose: prevention, treatment or management of ongoing complications.
Complex diabetes studies require robust statistical analysis.
TEMPO™, our fully integrated, single-database technology platform, allows for rigor often lacking in diabetes studies. Given the complex nature of these studies, more robust statistical analyses are typically required to account for potential confounders. Based on our expertise in experimental design, statistical analyses and regulatory requirements appropriate for this research area, we can help develop the most appropriate analysis plan to ensure success during protocol development.
Access a targeted study population through our global network of experienced sites and investigators.
Identifying the most appropriate study population during the initial planning phase can be a challenge in diabetes studies. Having access to this population, whose definition might be quite narrow depending on the exact indication, through our global network of experienced sites and investigators is a huge advantage that can save you valuable time and resources.
Monitor adverse events in real time and allocate resource savings.
With TEMPO, you have access to a technology-amplified, risk-based approach to monitoring that allows you to monitor enrollment and adverse events in real time. As a result, you can potentially save up to 30% of study costs versus a traditional, on-site monitoring approach. You could then potentially allocate resource savings to monitoring to help understand the effect of therapy on long-term outcomes for this chronic disease.
Putting our experience to work for you.
We have extensive experience managing multiphase diabetic drug, biologic and device trials, including Phase 1-4 clinical trials, IND and CTA submissions, eCTD submissions and statistical consulting.
- Phase 1: 13
- Phase 2: 20
- Phase 3: 50
- Phase 4: 23
- Registry: 4
- Statistical Consulting: 16
- Auditing: 1
- Device Registry: 9
- eCTD: 2
- Monitoring FSP: 1