Data Management

Astranova Research offers customized data management solutions tailored to your specific needs for any study in any therapeutic area. Our data management team has extensive industry experience across contract research organizations, biotech, medical device, and pharmaceutical companies. Our team includes certified database builders and medical coders. Therapeutically, our team aligns with our scientific leaders in core areas such as renal, oncology, cardiology, and respiratory, as well as having experience in many other areas including medical device studies.

Global Network Combines Data Management, Research, and Therapeutic Leadership:

As one of the leading data management teams in the Asia-Pacific region, with staff located in Australia, Europe, India, China, and the USA, Astranova Research can operate across all time zones with local representation. As a contract research organization (CRO) with offices in Asia, the USA, and Europe, we engage some of the world's most distinguished scientific expertise in a diverse range of therapeutic areas. This allows us to leverage our scientific leadership to establish and maintain unique investigator networks across the globe.

Customized, Cost-Effective, Integrated Solutions Across the Globe:

Astranova Research specializes in developing and maintaining databases for a wide range of study types, from simple questionnaires to large global registration studies, customized to each study's unique requirements. We deliver cost-effective solutions for epidemiology, registration, and post-registration studies for both academic and commercial customers. Our teams across the Asia-Pacific region, Australia, Europe, India, China, and the USA provide solutions specific to each region, with experts in local practices and customs. Our quality-by-design approach uses a risk-based methodology and adheres to SOPs for all standard clinical data management tasks, ensuring consistency and quality in data management services across studies and regions.

Data Management Services Include:

  • Protocol review and design of CRF and attendant specifications
  • Design, testing, validation, and maintenance of 21 CFR Part 11 electronic databases
  • Regular data review/cleaning/query management
  • External data reconciliation
  • Web-based randomization and IP dispensing
  • Integration with external randomization systems
  • Database administration including user management and site staff training
  • Medical coding (MedDRA and WHO-DD)
  • Electronic patient-reported outcomes (ePRO)
  • Endpoint adjudication database design and set-up
  • Application development and integration with EDC through APIs
  • Good documentation practice
  • Disaster recovery and backup services
  • Data entry services
  • Risk-based monitoring