FAQ
We are a team of specialists, working on studies that demand focus, precision and ownership. Everyone has a clear role but understands how their work fits into the bigger picture.
What services does DICE provide for clinical trials?
DICE provides full-service support for clinical trials, including clinical study design, biostatistics, statistical programming, data management, medical writing, medical monitoring and central imaging review. We support studies from early design through to analysis and regulatory submission.
How does DICE ensure regulatory compliance in clinical trials?
All services are aligned with international regulatory standards, including ICH and CDISC. We ensure that study design, datasets and documentation are prepared in a structured and consistent way, supporting regulatory review and submission.
When should a CRO be involved in clinical study design?
Early involvement is critical. Engaging DICE during the study design phase helps define clear objectives, appropriate endpoints and realistic sample sizes. This reduces the risk of delays, protocol amendments and regulatory issues later in the study.
How does DICE ensure data quality in clinical trials?
We focus on data quality from the start, through structured CRF design, consistent data validation and clear documentation. This approach minimizes discrepancies, improves traceability and ensures that datasets are ready for analysis and regulatory review.
What is the role of central imaging review in clinical trials?
Central imaging review ensures consistent and unbiased evaluation of imaging data across all study sites. DICE provides blinded independent central review (BICR) and applies validated criteria such as RECIST and iRECIST to support reliable endpoint assessment and regulatory acceptance.
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