kSuite™ Technologies

  • kClinion™

    Karmic’s Proprietary, Web Based EDC Platform

    kClinionTM is Karmic’s Proprietary, 21 CFR Part 11 & CDISC Compliant, Highly Scalable, Web-Based, Electronic Data Capture (EDC) platform designed especially to support global, multi-centric Phase II-IV clinical trials. Currently the system is running on Version 2.0 and is supporting a few global clinical programs. We are further working at launching iPAD/PDA-enabled versions of eCRFs on kClinionTM. Some of the salient features of the system are:

    US-FDA 21 CFR Part 11 Complaint System

    • Fully Validated with comprehensive IQ, OQ, PQ documentation
    • Secure, Roles Based Access & Authority Checks
    • Electronic Signatures & Records
    • Audit Trail for all process activities

     

    Intuitive, User Friendly GUI based Interface

    • GUI interface for database design/edit checks with re-usable frameworks and minimal programming
    • API based modular system with ease of adding new system modules quickly and efficiently
    • Full Integration with MedDRA and WHO-DD and integrated Lab Loader module
    • Highly customizable adhoc and custom reporting and dashboards
    • Data extract in SAS, CSV, SQL etc.

     

    High System Scalability with Low Cost

    • Ideal for multi-site, multi-user (> 200 Sites/Users per Trial) late phase trials
    • Low bandwidth usage, minimal infrastructure requirements for set-up and strong reliability
    • Low per user/per site cost along with low hosting and maintenance costs

  • kTrials™

    Karmic’s Proprietary, Integrated Data Repository & CTMS Platform

    kTrialsTM is Karmic’s proprietary, 21 CFR Part 11, CDISC and SDTM Compliant, Web-Based, Clinical Trial Management System (CTMS) designed especially to support Karmic’s Global Clinical Operations and Project Management. The system is currently in the implementation stage and supports end-to-end operational activities from project planning, budgeting, set-up, execution, performance and reporting for all clinical trials conducted by Karmic. Some of the salient features of the system are:

    US-FDA 21 CFR Part 11 & SDTM Complaint

    • Fully Validated with comprehensive IQ, OQ, PQ documentation
    • Secure, Roles Based Access & Authority Checks
    • Electronic Signatures & Records
    • Audit Trail for all process activities
    • SDTM compliant with mapping of all 33 SDTM domains in the system datahub

     

    Full Scale CTMS capabilities

    • End-to-end CTMS capabilities to handle project management, site management, resource management, performance management, quality assurance, SLA tracking & budgeting activities
    • Automated workflows for all critical tasks and activities with tollgate based approval
    • Sophisticated reporting across 20+ critical operational/quality metrics with 4-level drill down
    • SLA deviations and root cause analysis to enable actionable governance and exception management

     

    Integrated Clinical & Non-Clinical Data Repository

    • kTMH (Karmic Trial Management Hub), integrated Karmic clinical and non-clinical data repository
    • Integrates data from multiple systems including kTrialsTM, kClinionTM, Clintrial, OC/RDC, SAS, Lab etc. using ETL layer to create standardized and uniform organizational data
    • SDTM & CDISC compliant with mapping of data across all 33 SDTM domains
    • Data collation and meta-analysis capability across multiple trials

     

  • kMetrics™

    Karmic’s Integrated, Web-based, Metrics Reporting Dashboard

    kMetricsTM is Karmic’s integrated Web-based, Metrics Reporting Dashboard that collates data from multiple systems including CDMS, EDC, CTMS, IVRS, Lab etc. across a single program on a daily/weekly basis and provides a customized, real time view of all key study related project metrics to the sponsor.  Karmic further uses SAS eBI (Enterprise Business Intelligence) solution to create sophisticated, highly customizable, high-end dashboards and reporting frameworks with advanced analytics and drill-down capabilities. Thus irrespective of the geographical location or time zone of the sponsor, the sponsor project manager can get a real-time view of the study data, drill down to site/patient level to analyze data and provide appropriate inputs to the study team.

    The system has secure, roles-based access and can be customized as per sponsor requirements to include study documents repository, product information, study update mailers and newsletters and is offered as a value-add to traditional reporting requirements of sponsors.

  • kGyan™

    Karmic’s Online Learning Management Portal

    kGyanTM is Karmic’s Online Learning Management Portal build on Moodle open source technology. The system enables Karmic to train its global project management and monitoring staff using a simple web-based interface.

    Karmic has created 200+ online courses across 10+ modules that cover a broad set of topics across clinical research including therapeutic courses, GCP courses, SOP courses, Management Development and Soft Skills courses etc.

    Supervisors first do a Competency Mapping, Training Need Identification and Learning Path Definition of team members and then assign courses to their team members and evaluate the team members proficiency level through assessment exercises post which they can either be released for an activity or re-trained. Employees can further do self-learning and take assessments and get certified on the basis of these assessments.

  • Third Party Technologies

    Best-in-Class, Industry Standard, Third Party Applications

    Karmic uses a host of best-in-class, industry standard, third party applications and softwares to support its clinical trial needs. These include:

    • ClinTrial 4.7 CDMS: Phase Forward’s (Oracle) 21 CFR Part 11 compliant Clinical Data Management System for paper CRFs
    • Oracle® Remote Data Capture (ASP Hosted Model): Oracle’s 21 CFR Part 11 compliant remote data capture platform
    • Oracle® Argus (ASP Hosted Model): Oracle’s 21 CFR Part 11 compliant safety and pharmacovigilance business intelligence and analytics platform
    • SAS® Enterprise Guide 4.2: SAS Statistical Analysis Software
    • SAS® eBI: SAS Enterprise Business Intelligence & Analytics Software
    • MedDRA 14.1: Medical Coding Dictionary for Adverse Events from MSSO
    • WHO-DD: Medical Coding Dictionary for Concomitant Medications from Uppsala Monitoring Center