DICE (Data Investigation Company Europe)

At DICE, our mission is to enhance access to medical treatment by delivering excellence in the design and execution of clinical trials.

Located at the heart of the Belgian Biotech, DICE is a Contract Research Organization with over 30 years of experience in the execution of clinical trials, having assisted in the execution of over 300 studies from Phase I to IV across a range of therapeutic areas and medical technologies.

We have a reputation for delivering high quality results to our customers. Over 80% of DICE’s business is recurring, with long-term business relationships lasting up to 25 years. We have an international portfolio of clients from Europe, the US, and Asia.

DICE primarily works with start-ups and scale-ups, and we are organized to deliver maximum service to these types of companies. We work together with our customers to define the essence of the work to be done. We subsequently execute our work efficiently in full compliance with regulatory guidelines.

DICE has expertise in a variety of therapeutic areas including oncology, neurology, ophthalmology, hematology, orphan diseases, endocrinology, gastroenterology, pneumology, urology, autoimmune diseases, diabetes, metabolic disorders, and pediatric diseases.

DICE offers a variety of services including:

Clinical Study Design: DICE offers full support in the statistical design of clinical studies. Our experienced staff can help efficiently develop the statistical components of the study to ensure your project is accurately analyzed.
- Superiority, non-inferiority, equivalence, cross over, adaptive designs
- Endpoints, surrogate endpoints, biomarkers
- Trial populations
- Stratification factors
- Sample size calculation

Clinical Data Management:
- CRF design and development
- (E-) clinical database set up
- Medical review and data validation
- Clinical coding
- SAE reconciliation
- Integration and reconciliation of external data
- CDISC SDTM conversion

Biostatistics:
- SAP redaction
- Statistical analysis
- ISS and ISE analysis
- Biomarker analysis
- Bayesian statistics
- Futility analysis
- PK and PD modeling
- QOL scale development

Statistical Programming:
- CDISC ADaM conversion
- CDISC SDTM conversion
- TFL programming
- DSMB listings
- BIMO listings
- Listings of individual data/patient profiles

Medical Writing:
- ICH E3 clinical study reports
- Manuscript preparation for scientific journals
- Selected protocol sections
- Posters and presentations

Medical Monitoring:
- Medical support at startup and execution of studies
- Coding review
- Medical coherence review
- DSMB preparation

Central Imaging Review: Our medical imaging specialists at DICE have in-depth knowledge of Radiology and Nuclear Medicine and can coordinate study-specific imaging needs. Our technology and methodologies can be used for all trials involving DICOM images.
- Creation of CIR-specific SOPs to guide the imaging process from study start to finish (protocol design and Imaging Charter development)
- Development of the imaging site selection process (selection of site personnel, imaging scanner criteria, etc.)
- Production of the trial-specific Imaging Procedures Manual to describe overall procedures for the CIR and imaging sites
- Qualitative and quantitative image analysis for a wide range of available imaging modalities using up to date, internationally validated scan interpretation criteria (RECIST, iRECIST, EORTC, Choi, Deauville criteria, LYRIC, etc.)
- Blinded independent central readings (BICR)
- All data management aspects of CIR
- Definition and formulation of new and novel scoring and interpretation procedures that are tailored to investigate your novel technique(s)