Data Management

Recognizing the critical importance of reliable and quality data in the clinical trial process, KlinEra provides comprehensive data management services for all phases of the clinical trial, emphasizing quality control and state-of-the-art technology.

We provide complete data management services (data processing, analysis, and management) via expert personnel including bioinformatics specialists -- researchers that are proficient in clinical software tools.

Accuracy and integrity are reinforced with timed quality assurance procedures and timed status reports, according to the project’s requirements.

Our comprehensive data management and biostatistics services include the design of electronic or paper Case Report Forms (CRFs), database design, and validation (with single or double-entry/adjudicated data entry available).

We also provide detailed tables, listings, graphs, reports, and documentation according to regulatory compliance of the client country, including: protocols, interim and final clinical study reports, investigator’s brochures, new drug applications, manuscripts, abstracts, and integrated summaries of efficacy and safety.

Customized data management plans are developed in close communication with our clients and all services are performed in compliance with Good Clinical Practice (GCP) requirements and are available for all phases of clinical studies, as well as post-market clinical trials and post-market surveillance.

Data management services include:

  • Data quality management
  • Quality control of data
  • Querying the data for completion
  • Edit checks
  • Data Lock
  • Data validation and analysis
  • Creation of study reports
  • Assistance in writing the interim and final reports
  • Protocol writing
  • Tracking protocol deviations
  • Drafting of CRFs
  • Database creation and data lockup