DATA THAT MATTERS

Complete data governance for clinical research.

BioDome focuses on

Our main expertise and efforts are concentrated at following areas.

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Clinical Data Management and Statistics

Statistical analysis plan, sample size and protocol writing support. Clinical database setup and validation. Collecting, cleaning and coding of data. Data governance and warehousing.

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CDISC data standards conversion

Collecting in accordance with CDISC standards. Converting legacy data to CDSIC standards. Clinical data programming.

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Custom applications for Clinical Research

Developing and integrating custom software tools for clinical research. (e.g. IWRS, CTMS, etc.)

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Clinical Data Management and IT Auditing

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.

Team capabilities

In depth experience with

21 CRF part 11 (FDA)

Conformance with electronic records and electronic signatures regulatory guidance.

GAMP 5 (ISPE)

Applying a risk-based approach to compliant GxP computerized systems in building and validation of clinical research applications.

CDISC

Collecting and mapping data into well known industry SDTM and ADAM standards.

Phases

Experience in completing projects from phases I, II, IV and Biosimilarity.

Team figures

More than 150 clinical trial projects completed.

Audits

More than 50 system and project audits passed.