Human Clinical Trials – Enable evidence-based value development
Consistent, Collaborative, Creative: Design and evaluation of human clinical trials
Adding value by formal assessment of causal evidence to support your development of diagnostics, new drugs, biological products, medical devices/therapies or treatments (e.g., surgical procedures among others). During a trial or an epidemiological study, more and more information is gained about the diagnostic / drug / medical device / treatment, its risks and how well it may or may not work.
Pooling all this empirical evidence together, our team of experts help you to rigorously evaluate it. We provide comprehensive services, right from statistical design of studies, accelerated literature reviews, to quantitative and qualitative evaluation.
What we provide
We provide comprehensive services for design and statistical evaluation of the following types of non-commercial and commercial clinical studies.
| QuoData provides | related Regulations/Guidelines |
| Non-commercial clinical studies: investigator-initiated trials (IIT) | according to GCP guidelines and the declaration of Helsinki |
| Diagnostic studies | according to EU regulation 2017/746 |
| Clinical studies for medical devices | according to EU regulation 2017/745 |
| Clinical studies for pharmaceuticals | according to GCP guidelines and ICH guidelines |
Our services include
- Consulting related to statistical aspects of study design and the study protocol
- Study objective, study population, study design, and study procedure
- Statistics: primary and secondary endpoints, statistical methods, estimation of sample size, level of significance and power
- Consulting related to Statistical Analysis Plan (SAP)
- Sample size
- Randomization
- Statistical methods / approaches / procedures
- Statistical evaluation
- Plausibility check of data
- Statistical evaluation taking into account drop-outs
- Reporting of results
Target audience
- Clinical research institutes
- Hospitals that are active in medical research
- Diagnostic companies
- Medical device manufacturers quality
- Pharmaceutical companies
- Clinical Research Organization (CRO)