Clinical data management

“Organized data – controlled outcomes.”

Data collection

We ensure the secure collection of high-quality data using our proprietary electronic data capture system, CLADE-IS (EDC), tailored to client needs. We consult with physicians to align data collection with the specifics of the medical field and collaborate with potential data providers to ensure user-friendly data entry. All collected data is carefully monitored and verified.

Clinical data management

Data Management Planning and Design

  • Development of a Data Management Plan (DMP) defining the processes for data collection, verification, and processing
  • Design of the eCRF and verification of its consistency with study documents such as the CRF and study protocol

Data Integration from Various Sources

  • Digitization of data from paper-based collection, quality control of data transformation into electronic format
  • Design of the principles for merging data from different data sources
  • Implementation of data integration and testing

Creating a Database for Clinical Data Collection and Management

  • Converting study structure into electronic form, eCRF, in our own EDC system, CLADE-IS
  • Setting up validation rules and advanced features of the EDC system to facilitate data collection
  • Coding medical terms (SNOMED, MeDRA, ICD, etc.)
  • Transforming data into the OMOP model or other standards

Training and Support for System Usage

  • Creating a technical manual for working with your database
  • Training centers and investigators on how to use the database
  • Availability of technical support throughout the project duration

Data Cleaning

  • Monitoring data quality using automated processes and manual checks
  • Identifying discrepancies in the form of “queries,” for which the data author is asked for resolution, and reporting them
  • Regular assessment and review of discrepancies by the data manager

Study Status Reporting

  • Preparing reports informing on the status of the ongoing study — patient recruitment, participation of individual sites, statistical monitoring of collected data, etc.
  • Preparing and validating reports as per client requirements

Updating eCRF Structure

  • Client-requested changes in the study structure (eCRF) and processes related to study protocol amendments
  • Maintaining documentation on changes to the study structure and eCRF

Pharmacovigilance

  • Setting up rules for reporting vigilance according to client requirements
  • Reporting adverse events

Database Management

  • Managing access rights
  • Managing the rights of different user groups
  • Closing the database at the end of the project and cleaning the data
  • Preparing datasets for analysis, regulatory authorities, etc.
  • Archiving the database