Complete data governance for clinical research.
Our main expertise and efforts are concentrated at following areas.
Statistical analysis plan, sample size and protocol writing support. Clinical database setup and validation. Collecting, cleaning and coding of data. Data governance and warehousing.
Collecting in accordance with CDISC standards. Converting legacy data to CDSIC standards. Clinical data programming.
Developing and integrating custom software tools for clinical research. (e.g. IWRS, CTMS, etc.)
IT infrastructure qualification, change control and maintenance. Computerized system validation for clinical research. Clinical data management auditing services.
Established in 2015 from professionals with more than 15 years throughout knowledge in Clinical Research. Located in Sofia, Bulgaria.
In depth experience with
Conformance with electronic records and electronic signatures regulatory guidance.
Applying a risk-based approach to compliant GxP computerized systems in building and validation of clinical research applications.
Collecting and mapping data into well known industry SDTM and ADAM standards.
Experience in completing projects from phases I, II, IV and Biosimilarity.
More than 150 clinical trial projects completed.
More than 50 system and project audits passed.