By applying vast experience, broad medtech knowledge, and programming and data management skills, Avania’s data analysts are a vital part of your study team.

Avania’s data management team continually adapts, remaining knowledgeable about ever-changing regulations and fluent in state-of-the-art technologies that expedite clinical trials and decision-making. Our data analysts understand the requirements and needs of studies and work closely with cross-functional teams from clinical, regulatory, medical writing, and statistics to develop effective case report forms and cutting-edge electronic clinical databases.

Avania ensures your data is well-structured, clean, consistent, and in the correct format to support the claims in your clinical study report. Committed to delivering within set timelines, we routinely accomplish clean database lock within days of Last Patient Last Visit.

Full-Service Data Analytics

Avania case report form (CRF) design, specifications, and completion ensure an effective framework for your electronic database.

  • Flawless translation from study protocol into CRF data fields
  • Accurate and efficient data collection
  • Well-structured and unambiguous dataset
  • Data collection in accordance with Clinical Data Interchange Standards Consortium (CDISC)

With standard or customized database design and development, Avania will hand-select the best platform to suit your study.

  • Database analysis supports your trial across any electronic data capture (EDC) system of your choice
  • Standard Avania database setup services deploy DFdiscover® or iMedNet®, with features including:
    • Data entry modules (e.g., EDC, paper, hybrid)
    • Electronic patient-reported outcomes (ePRO)
    • Application programming interface (API)
    • e-signature
    • Randomization
    • Clinical data coding
    • Site staff training
    • Automated email notifications
    • Risk-based monitoring
    • Dashboards and reporting
    • Visit planner
    • Institutional review board (IRB) tracking
    • Investigational product (IP) inventory tracking
    • Site payment tracking
    • Clinical trial management system (CTMS)

Prevention is better than correction in data validation design/discrepancy management.

  • Manual and programmed checks to confirm clean, consistent, and unambiguous data
  • Comprehensive documentation
  • Automated checks on data at the point of entry; also subject to manual review within one working day
  • Significant reduction in queries, lowering costs and labor

Easily note trends and recognize when appropriate actions must be taken.

  • Visualization of data for better insights
  • Real-time data reports and tabulations, automated event notifications, and customized reports from an Avania certified SAS® programmer
  • Insights regarding safety data trends, safety reporting, eligibility/enrollment issues, data outliers, site performance, CRA performance, CIP or CRF imperfections, and more

Structure your data to accelerate global regulatory review/acceptance.

  • Application of CDISC standards (CDASH, SDTM, and ADaM) to data
  • Flexibility to convert legacy data

Save data entry, source data verification (SDV), and data cleaning time and effort.

  • Enables two (API-compatible) systems to interface, pushing or pulling certain pieces of data
  • Contained within latest release of the DFdiscover® software, in use by Avania’s data management team
  • Allows data to be pulled directly from an external source (e.g., site EPD) into your database 
  • Integration with third party vendors, core labs, imaging, etc.
  • Eliminates need for extensive data entry, validation, and data cleaning

Save time at the end of your study with prompt data resolution.

  • Extensive planning and site management to safeguard data continually through study close
  • Clean database lock within days of Last Patient Last Visit and almost immediately after last monitoring visit

Get help coding your data to the applicable dictionaries.

  • Data encoded to MedDRA, WHO Drug/WHO DDE, and WHOCC ATC by certified medical coders

We provide double data entry for paper-based and hybrid studies.

  • Database management system that supports uploading paper CRFs by fax or email
  • System automatically assigns image to correct patient and study visit while a handwriting recognition system pre-enters data from the paper image, relieving manual workload 
  • Empowers efficient remote data entry while safeguarding quality