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Clinical Data Intelligence for Life Sciences

Speed regulatory approval with high-quality, compliant documentation

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57%
of trial documents are misfiled or missing, with widespread use of high human-touch methodologies to classify and verify documents[1]

Overview

Person speaking to a medical professional behind a desk

The clinical trial pipeline is the revenue lifeline for Life Sciences companies. While trial documentation is often captured in electronic data capture (EDC) solutions, high human touch processes remain, leaving organizations managing millions of records with little insight into content or context. As a result, documents are mislabeled and misplaced, impacting data quality, increasing queries and slowing the road to database lock.

Clinical Data Intelligence for Life Sciences solutions enable efficient and intelligent data collection and classification, reducing errors and accelerating filings.

Key benefits

Impact business and achieve better results.

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  • Reduce costly delays

    Avoid setbacks in bringing Life Sciences New Medical Entities (NMEs) to market with intelligent clinical data management software to accurately get to filing, faster.

  • Improve trial data quality

    Reduce data discrepancies, queries and errors by gaining quality metadata from high volumes and formats of unstructured data with clinical data intelligence.

  • Meet stringent compliance requirements

    Reduce risk with compliant clinical data management services that support policymakers’ regulatory audit and reporting requirements.

  • Tackle growing Life Sciences trial complexity

    Increase efficiency and agility of clinical data management services for biologics and personalized medicine in decentralized trials.

  • Apply insights to future trials

    Enable data scientists to intelligently extract Life Sciences clinical trial data and leverage insights for trial improvements.

Business impacts

  • Data accuracy

    Manually handling high volumes of clinical trial data is time consuming. High human touch processes are prone to errors, degrading data quality and slowing processes even further. Save time managing clinical data with automated data collection.

  • Data classification

    Filing deadlines are tight and leave no time to waste. Searching for mislabeled and misplaced clinical trial documents takes up valuable time. Accurately identify, classify and manage clinical data to meet deadlines and get to market first.

  • Database lock

    Analysis, report writing and filing depend on clinical data set finalization. Missing or incomplete metadata is hard to find with manual processes and data silos, delaying finalization. Automate and streamline to get to database lock faster.

  • Trial insights

    Trends hidden within clinical trial data can be the key to improved innovation. Disconnected systems and classification processes lack quality metadata to help spot them. Uncover new trial insights with clinical data intelligence.

  • Existing system investments

    When systems are siloed, there are multiple solutions to maintain. Resources spend time on technology support rather than innovation. Connect life sciences systems to maximize investments and minimize upkeep.

View the infographic

Explore the components of the solution

Products

Solve Clinical Data Intelligence for Life Sciences challenges with OpenText.

Professional Services

OpenText combines end-to-end solution implementation with comprehensive technology services to help improve systems.

Clinical Data Intelligence for Life Sciences resources

Footnotes

  1. [1]Clinical Researcher, COVID-19 Creates Urgent Need for Remote Monitoring in Clinical Trials,, May 2020