OpenClinica

Electronic Data Capture Solutions for Clinical Trials

1075 Main Street,
Suite #140, Waltham,
MA 02451,
United States of America

1075 Main Street,
Suite #140, Waltham,
MA 02451,
United States of America



OpenClinica offers electronic data capture (EDC) solutions to enable simplified study build, data capture, data cleaning, and data management in clinical trials.

Our software as a solution (SaaS) solution is proven and trusted in over 10,000 studies by pharmaceutical, biotech, contract research organisation (CRO), academic research organisation (ARO) and medical device companies across the globe.

We provide clinical researchers, data managers and study participants with the necessary technology to enhance patient safety, clinical data quality, clinical trial speed and regulatory compliance.

Furthermore, we support some of the most critical and innovative clinical research transforming healthcare today.

Our unique focus is simplifying the complexity of clinical trials. Enabling clinical research teams of all sizes and levels of experience to deploy capable studies without any specialised technical expertise, resulting in greater efficiency and better data. This summarises our vision and shows how we can help to advance clinical research and patient safety.

Drag and drop study designer for efficient and fast clinical trial setup and management

Enhance the performance of study start-up with intuitive drag-and-drop study setup tools.

Our industry-leading design → test → production workflow allows you to collaborate with stakeholders and colleagues in real-time, ensuring electronic case report form (eCRF) version control and data quality for your clinical study, mid-study changes and protocol amendments.

ECRFs for clinical data management

With no need for highly skilled database programmers, you can design your forms in far less time with an extensive set of example eCRFs and eCRF Library to utilise and adapt as required.

Through OpenClinica, there is no longer a requirement for highly skilled database programmers.

Patient engagement via ePRO module

Our Participate ePRO module enables a frictionless way to engage your study participants. Patients can use their own devices (BYOD) and the system can send push notifications through email and SMS, with reminders to show up for visits or complete forms.

Enable subjects to take part in your studies from any location and any device with one-click access. EPRO data is fully integrated and immediately available with the rest of your study data.

Clinical study metrics

You can construct, visualise and analyse clinical study metrics with customisable dashboards and reports for progress metrics, key performance indicators (KPIs) and much more, with no programming required.

Construct reports against clinical study data and metadata (including audit log data, monitoring data and queries data) and gain access to this data through a structured query language (SQL) database. You can also connect third-party data sources and thrill your clinical team, business partners and statisticians with automated pulses and alerts via email.

Clinical study data management acceleration

We enable you to capture complete, high-quality research data.

Intelligent query management, source data verification, protocol versioning (including site-specific customisations), forced reason for change and more make up our data management and monitoring feature sets.

System-agnostic data interoperability via web services API

You can leverage our extensive standards-based web services application interface (API) with our tools for system-agnostic data interoperability.

Our API can enable you to send data to the right place in real-time, whether you need to incorporate data from a medical device or integrate with clinical trial management system (CTMS) or electronic health record (EHR) systems.

Data creation and data export tools

We provide on-demand, self-service access to your data with easy dataset creation and data export tools.

You can export data in useful formats, including Relational Database Management System (RDBMS), Clinical Data Interchange Standards Consortium (CDISC), Statistical Package for the Social Sciences (SPSS), Software and Solutions (SAS), Excel and automate routine data exports.

Information security and regulatory compliance

We partner with Amazon Web Services (AWS) to offer ultra-reliable, high performance and highly secure IT infrastructure, complete with data encrypted in transit and at rest, as well as data loss architecture.

You can guarantee geographic data custody, resting easy with trusted reliability and round-the-clock system monitoring. Certifications include the International Organisation of Standardisation (ISO) 27001, Statement on Standards for Attestation Engagements (SSAE)16 System and Organisation Controls (SOC) 1, SOC2 Type II.

With our electronic signature capabilities, complete audit trials and a robust quality system, we enable you to demonstrate General Data Protection Regulation (GDPR), Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Practice (GCP), 21 Code of Federal Regulations (CFR) Part 11 compliance.

OpenClinica

1075 Main Street

Suite #140, Waltham

MA 02451

United States of America

+1 617-621-8585 www.openclinica.com