Signifikans Information

We are 8 experts in statistical analysis, data management, SAS programming and clinical cloud - all ready to deliver results to you in pharma, biotech, and medico. 👉 Statistical analysis and reporting is in safe hands We handle your clinical trial data from planning, organizing, and analyzing - all compliant with current ICH and GCP guidelines. We are happy to support you using our more than a decade of experience performing and optimizing statistical analysis and programming in a variety of therapeutic areas. 👉 User-friendly and compliant collection of clinical and patient outcome data Signifikans offer cost-efficient and web-based user-friendly Electronic Data Capture (EDC) solutions based on OpenClinica Enterprise with combined ePRO/eCRF set-up according to FDA 21 CFR Part 11 guidelines. 👉 Monitor your safety data at any time Signifikans offers continuous data monitoring and QC of the collected data. You can track your clinical data LIVE at any time by visualization via CLIN-DASH 👉 Do you plan data monitoring committee? We produce data packages for your DMC containing tables, figures, patient profiles etc. delivered for the DMC members in a secure and user-friendly way via CLIN-LINK. Dashboard solutions helps the members to get a quick overview of most important data points of interest. Surely you do not have to think of the practicalities of the meetings – we facilitate this for you 👉 Store and share sensitive clinical files GCP and GDPR compliant with CLIN-LINK When you need to share sensitive and large clinical files with external partners, you can use CLIN-LINK – an easy, safe and GCP compliant solution. See more at www.clinlink.eu 👉 Understand clinical literature and statistical concepts easy To date, Signifikans has successfully organized over 200 courses with +2000 participants making complicated publications easy to understand. We tailor make a course to your needs or read the books 'Medicinsk Statistik‘ or 'Vurder selv evidens'