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Achieving Interoperability between clinical trials software

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Integra IT understands and has the solution to an issue commonly faced by healthcare systems and clinical trials around the world: interoperability. Seamless integration between information systems in healthcare and clinical research must solve two problems; first, technical interoperability, which means that systems can reliably transfer data between them, and second, semantic interoperability, in which the system can understand the information from other systems.

 

Additionally, we know data integrity compliance has become a large and crucial part of clinical trials. Since 2002, the industry FDA guidelines: General Principles of Software Validation, have been available, which state the recommendations for software development life cycle management and risk management activities. The integration between systems not only represents a reduction in time, resources, and overall performance but also plays a key role in data safety and risk mitigation. 

 

In countries like the US, the Office of the National Coordinator for Health IT outlined a 10-year plan to achieve healthcare interoperability by 2024,  they stated in 2018 “interoperability is so complex, and it requires all of us to have some shared responsibility thinking through how we’re going to get there in a way that meets everyone’s needs and expectations”.

How we do it at Integra IT

  • We use regression analysis and regression testing to build our tools to ensure that newly integrated modules do not adversely impact the operation of previously integrated modules.
  • We do integration-level testing focused on data transfer and control across a system’s internal and external interfaces. External interfaces are those with other software, also known as communications links (2).
  • We guarantee that our tools are completely validated under usability and reliability criteria, mitigating risks for all the stakeholders, including patients and users. For validation matters, we use the GAMP (Good Automated Manufacturing Practices) in version 5, a guide that establishes a methodology to ensure the correct implementation of computer systems in regulated sectors such as the pharmaceutical industry.

 

Learning about interoperability has led us to offer more dynamic solutions to address the IT functional concerns of CROs, sponsors, and clinical research sites. Therefore, currently, Integra IT has made multiple integrations in record time, including the integration of Integra IT systems with RAVE (Electronic Data Capture) and Viedoc in Europe.

Historically, software systems in the life sciences field have not been as frequently standardized and interchangeable. However, now clinical trial industry software developers like Integra IT offer a complete software suite with component-based development tools and techniques, with high-end technology.

 

Schedule a Demo and learn more about our integrations: www.integrait.co

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