- Life Sciences
Clinical studies
Excellent CRO services supporting your clinical research in the areas of pharmaceuticals, food studies, and post-market clinical follow-up (PMCF) studies
Your reliable partner for successful clinical studies
At CERTANIA, we provide a full range of services in clinical studies, making us your ideal partner for conducting high-quality research. Our unwavering commitment to quality, compliance, and scientific excellence ensures that your clinical trials are executed with precision. Backed by an experienced team and cutting-edge infrastructure, we support you from initial planning through to successful execution and comprehensive documentation. Our services encompass the entire spectrum of clinical research, adhering to all relevant national and international standards and regulations.
Overview of our services
Clinical studies / Early Stage to Phase III
Clinical Data Management: GAMP-5, CFR 21 Part 11
- Database Creation and Management
- CRF Design
- eCRF and paper-based CRFs
- Plausibility Tests
- Query Management
- MedDRA and WHO ATC CodingBiometrics and Statistics: ICH E9
- Planning and conducting statistical evaluations
- Development of study designs
- SAS programming
- Creation of SDTM and ADaM datasetsElectronic data collection: GAMP-5, CDISC
- Monitoring of pharmaceutical safety
- Reporting of side effects
- Compliance with regulatory requirements for medicinal products and medical devicesCDISC-compliant data standards: CDISA, FDA, EMA
- Creation of CDISA compliant data packages
- SDTM and ADaM Submission Packages
- Adaptation to international regulationsDesign Development for clinical studies
Our Experts:
SocraMetrics
SocraTec R&D
Dinox
Bioarray
Biotesys
The industries:
- Life Science
- Pharma
- Medical devices
- Scientific community
- Food / agri Producers