Utilization of Technology Intelligence in your Clinical Research Program Leads to Improved ROI

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 Our Service

Utilizing a host of clinical research applications, ParadigmIT offers an extensive collection of services for pharmaceutical, biotech, medical device, and life science companies. We provide customized, end-to-end clinical data management services as per the client’s need. ParadigmIT team consists of functional, technical and industry experts who can successfully assist pharma and life science companies in navigating the complexity of the clinical trial lifecycle. This expert consulting can be leveraged to identify the most suitable and most cost effective clinical operational and clinical data management technologies from the market.

Combining Clinical Trial Data with Advanced Business Technology Saves our Clients Time and Money.

Our Service Offerings

ParadigmIT has assessed multiple systems and understands the best-in-class applications/tools for your clinical trials. We confidently offer our clients the right technology solution according to the trial design requirements. Our focus is to provide:

1. Technology enabled tools to speed up the trial start-up process
2. Standardized eCRF development ready to map into respective SDTM                domains
3. Unambiguous and quality data from sites through well designed eCRFs
4. Timely receipt of external vendor/third party data
5. Frequent review of safety and protocol end points data via BI tools
6. Insight to clinical operations and CDM teams on anticipated 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
           • Case report form (eCRF) design and review
           • Edit check development
           • Programming complex checks as allowed by each of the EDC            tools
    •  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
    • Study data archival
    • Custom function development (specific to RAVE)
    • Custom reporting and visualization development such as:
          • Business Objects reports Crystal Reports development
          • Spotfire business intelligence tools
          • Power BI tools
          • SAS/SQL based reporting
          • Custom scripts (specific to RAVE): Coder scripts | SIS integrations | Diagnostic scripts
    • Custom data extracts and integrations:
          • Scheduling SAS Jobs/SQL data extracts
          • SDTM/ADAM
          • Rave web services (RWS)/ODM extracts

    Other Services

    • Statistics Programming :
      Our comprehensive biostatistics services encompass the following, ensuring your research and healthcare projects are driven by robust statistical methodologies for accurate results and compliance:
           • Randomization
           • Data analysis
           • Clinical trial design, including sample size identification
           • Statistical consulting
           • Regulatory query support
    • Medical Writing
      Our expert medical writing team ensures that your scientific and healthcare content is clear, concise, and compliant, facilitating effective communication in the ever-evolving field of medicine.
      We provide the following services:

            • Investigator Brochures
            • Protocols
            • Clinical Study Reports
            • Safety Reports – Narratives
            • Manuscripts

    // Consulting

    Consulting for Clinical Trials

    The following are the validated customized solutions we offer to our clients:
    • Application development for pharma/life science companies to manage their routine tasks digitally to increase efficiency.
    • Advanced technology adoption to manage the new complexities in clinical trial execution reducing drug development turnaround time.
    • AL & ML powered Data Aggregation and Analysis to generate insight for the future drug development pipeline by:
      1. Defining disease prevalence
      2. Identifying potential drug candidates
      3. Collecting and analyzing post-marketing safety assessments
      4. Compiling current market feedback on marketed products to initiate a more targeted approach to the R & D process for a new molecule.
    Our software implementation consulting services are not limited to the clinical trial related software. Our services also extend to organizational level applications developed to manage day-to-day business activities. The most common services that we have provided in the last five years included a wide range of clinical applications and software that integrated with EDC platforms. The following are some examples:
    • 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 ask@paradigmit.com