Certania
Clinical Research
Our CLINICAL RESEARCH segment supports the clinical development of medicinal products and medical devices, covering every stage from study conception to robust regulatory evaluation. Within our dedicated clinical pharmacology units, we conduct both early and late phase trials –adhering to the highest GxP standards – from first-in-human studies to bioavailability and drug interaction assessments, as well as multicenter Phase II to Phase IV studies.
We assure data quality and regulatory compliance through expert clinical data management utilizing validated databases, flexible EDC, eCRF, and ePRO systems, in addition to structured biometrics, pharmacokinetics, and pharmacodynamics. All processes are fully compliant with CDISC, 21 CFR Part 11, and GAMP-5 standards.
This comprehensive approach delivers consistent, audit-ready clinical data, efficient development workflows, and a reliable foundation for decision-making throughout to final product approval.
For a humanity in certainty
ClinicalResearch
We have been dedicated to clinical research into women's health for over three decades. At our Berlin study center, we organize complex, cycle-dependent procedures such as daily transvaginal ultrasound examinations and regular blood samples in a reliable and structured manner – with a particular focus on proof-of-concept and dose-finding studies in areas such as contraception, endometriosis, fertility therapy, hormone replacement therapy and sexual medicine. Our experienced gynecological team, medically trained staff and an efficient recruitment system ensure high data quality in all clinical phases.
From acquisition to validation and analysis, we are fully dedicated to your study data: Our flexible EDC systems, eCRF and eDiary/ePRO solutions adapt quickly and efficiently to any research design. Data integrity and CFR 21 Part 11 compliance are firmly anchored in our IT practice. Our biostatistics, pharmacokinetics and pharmacodynamics teams support projects through all development phases – right up to marketing authorisation. We have been working according to CDISC and GAMP 5 standards since 2007 and develop customised, high-quality data solutions through our own programming group.
As a specialised service provider for clinical development, we offer planning, implementation and evaluation of studies – from early Phase I studies through to approval. We combine scientific depth with efficient project management and the highest GxP standards. Our portfolio includes study design, study plans, monitoring, project management and medical-scientific consulting. Together with our sister companies, we also support biometrics, data management and PV – seamlessly integrated and flexibly scalable. With our own infrastructure and experienced teams, we reliably realise challenging projects.
We have been developing specialised software and services for drug safety since 1993. Our GxP-compliant PV database saphëus® is provided as SaaS and enables safe, efficient and compliant case management – from ICSR processing and medical documentation to reports such as PSUR and DSUR. We also provide literature monitoring, regulatory submissions and modular support services for small and medium-sized pharmaceutical companies. We combine technological development, data security and in-depth regulatory expertise to create an integrated solution for pharmacovigilance.