ConneXon 2022

ConneXon 2022

About ConneXon

A secure, validated and modular system built to accelerate trials whilst increasing patient safety. This is achieved through parallel delivery of data for effectiveness and efficacy, and a close to real-time safety monitoring system configurable to the needs of each individual study. With data taken direct from source, trial costs are heavily reduced with minimal data validation overhead, fast end point identification and rapid study data provision.

Challenge

Traditional clinical trials are often time-consuming, expensive, and burden- some for patients. Overemphasis on internal validity can lead to the exclusion of certain patient populations, which leads to poor generalisability and may undermine the safety for patients who will use the drug or device once its approved. Real world evidence studies are growing in acceptance for use with regulators, payers, prescribers, and patients. While incorporating real world evidence enables greater accuracy in evaluating new drug therapies it also creates a challenge in ensuring the generation of robust treatment outcomes and meeting regulatory requirements.

Solutions Process

  • eCRF (electronic case report form) - a configurable eCRF module allowing the collection of data to supplement the data taken direct from source; offers the ability to integrate with other parts of ConneXon facilitating a hybrid study design.
  • Activity Summary – real-time monitoring system for detecting significant study events e.g., Serious Adverse Events, protocol deviations or screening results.
  • Safety Reporter –secure and fast transmission of safety data direct to sponsor and regulator pharmacovigilance systems, using industry standards like ICH E2B R2/R3.
  • Dataset Generator – clinical data is transformed, structured and uniformly complied into a format meeting global data standards.

Benefits

A suite of technical solutions designed to accelerate end-to-end clinical processes and improve trial efficiency

  • Collects accurate and comprehensive data to create real-world evidence in clinical trials and research
  • Extracts health care records for consented patients to allow studies to be decentralised and enable virtual trials
  • Combines multiple data sources (e.g., EHR, HES, eCRF) to create harmonised datasets to international and regulatory standards
  • Captures clinical data directly from source reducing the need for manual data entry and source data verification
  • Close to real-time safety monitoring improves patient safety and enables faster risk benefit analysis
  • Improves overall trial efficiency and cost saving

Process

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