Our Services

Data management is an essential component of clinical trials. It consists of designing the clinical database, collecting trial data, and quality management—ensuring that all data conform to the FDA Title 21 CFR Part 11 and other guidelines.


Regardless of size, type, or complexity, accurate results for any phase of a clinical trial are ultimately determined by the quality of the collected data. Data management and trial organization are the keys to developing an accurate and reliable clinical trial.


Our services include:

  • Case Report Form (CRF) design
  • CRF annotation (by sponsor specs or CDISC standards)
  • Data Management Plan and CRF guidelines generation
  • Database development (including entry screen design)
  • Data entry (Clintrial™ / Oracle Clinical)
  • Electronic Data Capture (InForm™ / Oracle RDC)
  • Edit checks/queries generation and resolution
  • Data Management Validation and quality assurance
  • Coding of medical events (MedDRA / WHO-Drug)
  • Clinical quality control
  • CDISC related services
  • Sample size determination and power calculation
  • Randomization support
  • Ongoing biostatistics support (programming, analysis and reporting)
  • Medical writing, editing and review services
  • Pharmacovigilance and safety support
  • SOPs Writing


Professional management of the clinical trial data is critical to the success of your development process. CDMC provides you with advanced data management, analysis and reporting solutions alongside the assurance of quality and precision.