Our services related to data processing and supporting clinical
- Consultations and development of templates for a Case
Report Form, Informed Consent Form (ICF), and Investigator’s
- Establishment of an electronic database (eCRF on the REDCap platform)
- Establishing a randomization procedure and running and
running it throughout the study
- Programing data validation rules
- Staff training
- Overseeing the study process and data quality
(Data Management Plan) approved by the Sponsor.
- Compose data sets according to the CDISC standard
- Code adverse events using MedDRA dictionary
- Medical review of data (Medical Review)
All we do is defined in the Standard Operating Procedures (SOP).
The procedures comply with the principles of the Society for Clinical
Data Management (www.scdm.org– Good Clinical Data
Management Practices version 4.0.
We passed the audits for system compliance with the rules of the
US Food & Drug Administration – FDA 21 CFR Part 11 (2018, 2020).
The procedures undergo regular internal audits and external audits
mandated by our Clients.