Designed to streamline clinical trial management, ConneXon delivers secure, real-world data-enabled electronic data capture. With advanced real-time safety reporting, seamless data integration and regulatory-ready insights, ConneXon transforms how clinical trials are conducted, ensuring efficiency, accuracy and compliance.
Combine trial data with real-world data for deeper insights.
Create comprehensive and rich study datasets ready for analysis.
Collect real-world evidence that supports study endpoints with minimal need for eCRF entry or study visits.
Enable evidence-driven decision-making, improving trial outcomes.
Benefit from instant detection and reporting of serious adverse events.
Get faster response times, reducing risks and enhancing patient safety.
Achieve seamless regulatory compliance, ensuring data integrity for regulatory submissions.
Gain end-to-end encryption for secure data management.
ConneXon is built for scalability, supporting trials of all sizes.
Harmonise data sets into internationally recognised standards to support seamless regulatory submissions.
Power smarter decisions with real-world evidence
Streamline workflows, enhance safety monitoring and leverage real-world data for smarter, more efficient trials with ConneXon.
“ConneXon has revolutionised how we conduct clinical trials. Its seamless real-world data capture, coupled with the real-time safety reporting feature, has significantly reduced reporting delays and enhanced participant safety. The platform’s regulatory-ready insights and secure, scalable infrastructure let us confidently integrate complex datasets, streamline workflows, and maintain full compliance with ease. ConneXon is truly transforming trial management.”
ConneXon is a clinical data platform designed to streamline clinical study management through secure electronic data capture (EDC), real-world data (RWD) integration and advanced safety reporting. Going beyond a typical EDC ConneXon combines electronic case report forms, Electronic Health Record (EHR) data and external healthcare data sources to create analysis-ready datasets throughout a study lifecycle.
Most traditional EDC platforms capture only the data entered manually into electronic case report forms. ConneXon goes further by combining trial data directly with real-world data (RWD) from Electronic Health Records (EHR). ConneXon’s architecture connects EHR, eCRF, and external data sources to create comprehensive, analysis ready datasets throughout the lifecycle of a study.
ConneXon also supports eSource workflows by enabling data to be captured directly from healthcare records and connected systems rather than relying solely on manual transcription.
Yes. ConneXon is built to combine trial data with real-world data (RWD) for deeper insights, enabling evidence-driven decision-making and improving trial outcomes. Its direct integration with Electronic Health Records (EHR) means that real-world evidence can be collected from source with minimal disruption to clinical workflows, making it well suited to observational studies, decentralised pragmatic trials and real-world evidence generation.
ConneXon provides end-to-end encryption for secure data management and is built for scalability, supporting trials of all sizes. It harmonises datasets into internationally recognised standards to support seamless regulatory submissions. The platform is designed so that data integrity is maintained throughout, ensuring it is ready for regulatory review at any point.
ConneXon includes role-based access controls, audit trails and electronic signatures designed to support GCP and 21 CFR Part 11 compliance. ConneXon uses data from participants who have provided informed consent to take part in research. The platform is built around principles of data integrity including ALCOA+ and supports internationally recognised standards including CDISC SDTM.
Real-world data (RWD) refers to information collected outside traditional clinical trial settings, such as routine GP appointments, hospital visits and prescriptions, and electronic patient-reported outcome measures (ePROMs) providing valuable insight into how patients live and respond to treatment in their everyday life.
ConneXon integrates this data directly allowing users to populate parts of data forms with information extracted directly from a participant’s Electronic Health Record (EHR), reducing transcription errors and improving accuracy. This means researchers get richer datasets without increasing the burden on clinical staff or participants.
SAEfe, NWEH’s Serious Adverse Event reporting functionality powered by ConneXon, is designed to save up to 70% of the overall costs associated with reporting adverse events.
More broadly, by pulling data directly from EHRs rather than relying on manual entry, ConneXon reduces transcription work, lowers the risk of errors requiring correction, and minimises the number of study visits needed.
ConneXon includes a dedicated SAE reporting module called SAEfe. SAEfe allows users to complete SAE reports by auto-populating parts of the form with data extracted directly from the participant’s Electronic Health Record (EHR), reducing transcription errors and improving accuracy. Completed SAE forms are then securely delivered to the sponsor using the industry-standard ICH E2B ICSR format, making reconciliation a quick and easy process. This delivers faster response times, reduces risks and enhances patient safety while achieving seamless regulatory compliance.
NWEH’s approach across ConneXon aligns directly with, and in many areas exceeds, the intent of the UK’s new clinical trial regulations, the biggest overhaul of UK clinical research rules in over 20 years, which came into force in April 2026.
ConneXon harmonises datasets into internationally recognised standards to support seamless regulatory submissions and is designed to ensure data integrity is maintained throughout the trial, a core requirement for GCP compliance and submissions to bodies including the MHRA and FDA.
Yes. ConneXon is specifically designed to support decentralised and pragmatic clinical trial models by integrating data directly from routine healthcare systems and Electronic Health Records (EHR). This allows researchers to capture real-world clinical activity with minimal disruption to participants and sites, reducing study burden while improving the richness and quality of data collected.
Yes. ConneXon is designed to integrate with Electronic Health Record (EHR) systems and external healthcare data sources. This enables trial teams to use existing clinical data within study workflows, reducing manual transcription and supporting more efficient and accurate data capture.
ConneXon supports internationally recognised clinical data standards including CDISC CDASH and SDTM and can also support OMOP common data model outputs for observational and real-world evidence research. This helps ensure data consistency, interoperability and regulatory readiness.
EHR enabled EDC combines traditional electronic data capture (EDC) with direct integration to Electronic Health Record (EHR)s. Rather than relying entirely on manual entry into case report forms, relevant clinical data can be securely reused from healthcare systems to improve efficiency, reduce errors and support richer real-world evidence collection.
Yes. By allowing data to flow directly from Electronic Health Records (EHR) into study workflows and SAE reporting processes, ConneXon reduces the need for duplicate manual entry. This helps minimise transcription errors, improve data quality and reduce administrative burden on site staff.
Yes. ConneXon includes SAEfe, an integrated Serious Adverse Event reporting capability that supports rapid SAE processing and electronic submission using the ICH E2B ICSR standard. This helps sponsors and sites improve safety oversight while reducing reporting burden.
