Dash of Tech Intelligence to Clinical Trial Research Leads to Alchemy

Technology in Clinical Trial Services

Our Solution oriented approach is the strength till date that built our reputation as a Life Science Technology partner with our customers. We listen to our customers to understand the pain points in day-to-day tasks consuming their valuable resource pool. Our team works out of the framework to nullify or reduce the manual efforts by the valued resources to a greater extent. On the other hand, the Skill/knowledge can be utilized on more value-added tasks in saving patients’ lives.

About Service

ParadigmIT offers a host of services for pharmaceutical, biotech, medical devices, and life science companies ascended by host of Clinical Research applications. We provide customized, end-to-end Clinical Data Management Services as per customer need. ParadigmIT team consists of functional, technical and industry experts who can successfully assist pharma and life sciences companies in navigating the complexity of clinical trial lifecycle. The combined expertise consulting can be leveraged to identify the best suitable and pocket friendly Clinical Operational and Clinical Data Management technologies from the market.

Clinical Trial Data Combined With Advanced Business Intelligence Technology Will Benefit Our Customer To Save Cost And Time.

Organized Service Offering

ParadigmIT has assessed multiple systems and understands the best-in-class applications/tools for your Clinical Trials. We take all your worries to bring in apt technology solution per the trial design requirements. Our focus is to get
  1.  The trial kick off on time
  2. Standardized eCRFs development is ready to map into respective SDTM domains
  3. Collect unambiguous and quality data from sites
  4. Timely receipt of external vendor/third party data
  5. Frequent review of Safety and Protocol end points data via BI tools
  6.  Insight generation to Clinical Operations and CDM team on foresighted risks
  7. Custom solutions to handle the live integrated data of eCOA/ePRO

Quality Control (Contracted and Non-contracted)

  • Data Validation and documentation
  • Pre & Post Platform upgrade Validation
  • Audits for Test data validation

  • //Service Offerings

    Clinical Data Management (CDM)

    ParadigmIT offers, flexible engagement models through stand-alone, full service, or functional outsourcing in the following areas:

    • Database build, testing, and deployment
    • Data entry (if needed), validation/verification
    • Medical Coding
    • Safety and external data reconciliation
    • Site/CRA EDC training (on demand)
    • EDC user/site administration
    • Database lock and study closure
    • Database migration/rescue from legacy systems
    • Integration of EDC with other clinical applications
    • SDTM/ADAM Mapping
    • Study data archival
    • Custom Function development (specific to RAVE)
    • Custom Reporting and Visualization development
      • Business Objects Reports
      • Crystal Reports development
      • Spotfire Business Intelligence tool
      • Power BI tool
      • SAS/SQL Based reporting
      • Custom Scripts (specific to RAVE)

    Other Services

  • Statistical Programming
  • Medical Writing
  • // Consulting

    Consulting for Clinical Trial Services

    FOLLOWING ARE THE VALIDATED BESPOKE SOLUTIONS TO OUR CUSTOMERS

    • Application development for Pharma/Life Science companies to manage their routine tasks digitally with less human intervention
    • Advanced Technology adoption to manage the new complexities in Clinical Trial execution for a better TAT on Clinical Trial activities
    • Data Aggregation and Analysis to generate insight for the future trial pipeline
      1. Like disease prevalence
      2. Potential Recruiters
      3. Post marketing safety assessments
      4. Sales feedback to initiate the R & D for molecule efficacy

    Consulting service is not limited to the Clinical trial related software. This is extended to organizational
    level applications developed to manage day-to-day business activities. The major highlight whereour services strengthened/utilized to multifold in last five years is integrations with EDC platforms with a wide range of Clinical applications or S/W:

    • Randomization and Trial Supply Management (RTSM)
    • Clinical Trial Management System (CTMS)
    • Medical Imaging Systems
    • Cloud Administration
    • ePRO/eCOA
    • Safety gateway/DB
    • Targeted SDV support
    • Batch Uploader

    Excellence, Efficiency and Results

    One of the key factors for a successful clinical study is
    to have an experienced team who can confidently execute your clinical trial on time with utmost and high-quality deliverables.

    • Team of industry experts and clinical professionals
    • CDM “Full Service” support on all major EDC platforms
    • Experienced in multiple EDC Platforms on Study Build
    • Cost effective solution due to the technology/solutions
    • Disaster Recovery Planning and Execution

    Our focus is on utmost data quality and cost effective processes in validating the trial data. We had designed and tested the automated data validation/cleaning process keeping in mind the ease of adoption and pocket friendly to Customers. From the day we learnt Pharma industry will see a Paradigm shift in conducting trials our research involving industry experts and well qualified technology architects also began.

    The result of this brainstorming and research in the Clinical Trial conduct process involving multiple functional teams leading the ParadigmIT to be in the forefront.

    • Reduction of Specification review and Study build TAT
    • Improved Cognitive data insights generation using Business Intelligence tools
    • Reduction in data cleaning/validating TAT Improved KPI of LPLV to DBL
    • Recommendation of enhancing the EDC Platform and Clinical Tools based on our Technology DNA
    Thank you so much for visiting us. Should you have any queries,

    Please feel free to reach us at contactus@paradigmit.com