Protocol Guided Data Capture

Central to each indication-specific study database is a repository of eCRF forms.  Our oncology EDC study databases are built on:

  • Therapeutic area expertise as captured in The National Cancer Institute's Common Data Elements (CDE) library;
  • Industry standards defined under the  Clinical Data Acquisition Standards Harmonization (CDASH) standard - issued by CDISC;
  • Clinical drug development knowledge and expertise of our oncology pharma and biotech clients; 

Edit Checks

Edit/validation checks within each oncology EDC database have been built and validated on:

  • Therapeutic area specific knowledge and requirements;
  • Clinical development phase specific industry standards;
  • Study design specific requirements.

Protocol Guided Data Capture 

Based on more than a decade of experience and feedback from Study Coordinators and CRAs, SciAn has made a functional leap in the use of on-line data validation / edit checks.  In EDCPRO version 4.0, edit checks are part of a comprehensive "Help System" to guide Study Coordinators and Clinical Research Associates (CRAs / Monitors) in their interpretation of the protocol and manage study data accordingly.

Some key functionalities:

  • Study Coordinators are prompted to complete the highest priority tasks, such as requesting new study drug supply for the site or specific patients, reporting new clinic visits, correcting data discrepancies and responding to queries - without any administrative burden.
  • The on-line Protocol Guidance system guides Study Coordinators to follow protocol defined study treatment, concomitant therapies, and scheduling core assessments as closely as possible.
  • Monitors, Database Managers and Clinical Project Managers receive updates on current data and protocol conduct trends to (i) prompt productive discussion on issues with Study Coordinators and Investigators, (ii) update the Help & Protocol Guidance System, (iii) assess the need for protocol amendments / communicate the changes to Medical Monitors, Biostatisticians and Medical Writers.
  • Summary reports detect possible shifts in the characteristics of the patient population over time and across study sites