Clinical Data Management

Clinical Data Management

Using cutting-edge technology, strong procedures, and regulatory-compliant data management solutions, ICBiO offers timely and high-quality data from database design and setup through cleaning and reporting to database lock. We use CDISC standards to build electronic case report forms (eCRFs) and deliver final datasets using standardised, established, and compliant methods. We are experts in the creation of therapeutic area-specific eCRFs and can efficiently manage studies in any therapeutic indication, specialising in complicated trial designs. Our experts will walk you through the process, offer advise, and make certain that the data is of the greatest quality. We assist with the quick start-up and execution of studies while maintaining focused on resolving and managing risks, obstacles, and complexity for each project.
Untitled design

Our professional project team collaborates with you to build optimum strategies and tailor-made deliverables. We take pleasure in our open and honest approach, which emphasises communication, accountability, and ownership. When you work with our A-team, you can anticipate a lean management strategy to achieve operational excellence while managing costs, backed up by strong oversight and hands-on engagement from top executives. We recognise the value of remaining flexible while meeting project deadlines and producing high-quality products. We provide an excellent combination of global skills and a personal, proactive, pragmatic approach, with global coverage and skilled local resources.

ICBio data management team is comprised of industry veterans with more than 20 years of expertise in offering best-in-class services. Using cutting-edge technology and complaint data management solutions, we aim to encourage high-quality, useful data while still maintaining standards and good practises. We’ve worked with a variety of electronic data capture (EDC) solutions.

DATA Managment service

Clinical Data Management Services

ICBio provides data management services that include design, setup, and comprehensive data administration from start to finish, working cooperatively within established cross-functional processes with internal colleagues from various biometrics disciplines. This guarantees that the transition from data administration to clinical programming, reporting, and analytics is as smooth as possible. We provide a flexible and tailored approach to your project's unique demands, either as a full- service solution or by delivering stand-alone in-house services.

Among our data management services are:

• Data management, planning, and documentation for projects
• Creating plans for data management and validation
• Creation and validation of an EDC database (CDASH/SDTM compatible).
• Edit check programming, testing, and validation
• Data validation and data quality assessment for inconsistencies, trends, and
• Medical coding (MedDRA and WHODrug)
• SAE reconciliation
• Third-party data planning and management

  • Production and review of real-time EDC metric reports
  • Electronic patient reported outcome (ePRO) setup
  • IWRS setup and maintenance including randomization, drug dispensing
    and inventory management
  • Insights and analytics
  • Risk-based monitoring support 
  • DCT support
Clinical data management


Submit your details and we’ll be in touch shortly. You can also email us if you would prefer.

Copyrights © 2012 – 2023 ICBIO Corporation