Transform Clinical Development and outcomes

    Combine data, AI-driven analytics, standards, and consulting for next-generation clinical trials.

    Reimagining Clinical Development via data engineering and advance analytics

    It takes an average of 10 years for a new drug to come to market, with clinical trials alone taking 6–7 years. Moreover, the overall probability of clinical success is estimated to be only about 12%, and the average cost to research and develop each successful drug is high, estimated at $2.6 billion. The inability to demonstrate safety or efficacy, flawed study design, participant dropouts, unsuccessful recruitment, etc. have contributed to the low success rate of clinical trials.

    However, as the world advances to a more digitalized era, clinical trials are transforming by adopting new technologies and data-driven insights to:

    • progress towards virtual or decentralized clinical trials
    • improve the clinical trial cycle time and effectiveness
    • proactively monitor adverse event and early warning signals

    Our clinical service offerings

    Leverage Axtria’s deep domain and consulting experience along with AI-driven technology solution
    to support clinical development.


    Data fitness assessment

    Data fitness assessment

    • Identify data consistency, quality, and visibility gaps
    • The framework of process and governance to improve clinical data management
    • Ensure regulatory compliance of the data sets through its journey

    Standards management

    Standards management

    • Clinical Data Interchange Standards Consortium (CDISC) standards management from protocol design to regulatory submission
    • Enable trial optimization – resulting in faster outcomes
    • Provide automated and consistent mapping with data lineage

    Events monitoring

    Events monitoring

    • Support the regulatory submission process and adverse event (AE) reconciliation
    • Enhanced safety monitoring and corrective actions to increase the trial’s chance of success

    Advanced analytics

    Advanced analytics

    • Solve the clinical data aggregation and visibility constraints for better outcome
    • Provide robust controls to implement data quality and governance
    • Enable data validations across clinical data sets as per business rules

    Next generation clinical data management system (CDMS)

    Next generation clinical data management system (CDMS)

    • Site selection using both analytical and qualitative techniques to determine the most favorable location for a clinical study operation
    • Signal detection, monitoring, evaluation, and reporting of safety signals in AE

    Data verification and validation

    Data verification and validation

    • Clinical systems and their data sets follow GxP compliance
    • Verification and validation provide data compliance for all the above offerings

    Our work in Clinical Development

    Leverage patient-centric, advanced technology solutions that redefine drug development to improve the efficiency
    and outcomes of clinical trials.

    CDMS enablement

    Axtria partnered with a global pharmaceutical company to transform CDMS from an outsourced partner to a new platform managed by the company’s internal IT services organization. The effort resulted in quicker turnaround time and enhanced data exchange speed (94% faster), better user experience, secure data sharing and access, and real-time application log monitoring to detect issues.

    Clinical data processing solution for biomarker extraction

    A diversified healthcare company that supports community-based specialty practices across the US partnered with Axtria to use electronic medical record (EMR)/electronic health record (EHR) data to get a complete patient view and deliver clinical insights to physicians. Axtria built a highly sophisticated solution leveraging optical character recognition (OCR), natural language processing (NLP), and machine learning to enable easy dissemination of patient insights to physicians to aid R&D and improve the delivery of treatments to patients.

    Study management enrollment/ engagement prediction system

    A healthcare provider collaborated with Axtria to develop an advanced analytics-driven study management enrollment/engagement prediction system to identify trends in patient data using large volumes of high-velocity EMR and wearable device data. Several data sources were combined to provide patient health monitoring insights and alerts to a patient and her physician. The effort resulted in more frequent and actionable insights to stakeholders, including doctors, hospital network, and network administrators.

    Social listening monitoring for adverse events

    For the clinical trials group of a leading pharmaceutical company, Axtria built an adverse event reporting (AER) engine to automate the identification of adverse events using various natural language processing (NLP) and supervised machine learning techniques. The effort resulted in an 80% reduction in manual identification effort. The company can also configure the solution to provide insights for marketing and compliance.

    Impact to make for efficiency gains in Clinical Development processes

    Progress towards real-time data collection

    Find efficiencies (2x) to bring down lag times

    Move towards hybrid trials

    Prescriptive insights to change the way trials are conducted and gain efficiencies


    Axtria clinical research hub

    White Paper

    How to Make Omnichannel Less of a Struggle for Pharma Marketers


    Unraveling the Potential of Data Fabric: A Cutting-Edge Paradigm in Pharma Data and Analytics


    RWE in Clinical Trials – Market Trends and Use Cases