Some of the levers we use to jumpstart your trials

  • Rapid Site Feasibility

    kSiteX™, our proprietary site feasibility model has a custom database of 2000+ sites including approximately 347 active sites classified as per site category, therapeutic indications and trials experience as well as pre-defined templates for site assessment, site inspection, site feasibility qualification etc. that ensure that we process feasibility requests within 48 to 72 hours and provide a comprehensive site strategy, trial budget and timelines to the sponsor.

  • Crunched Trial Start-up Time through kTrials™ Toolkit

    We typically budget 20 weeks for trial start-up from the Protocol Synopsis Development Phase through the Regulatory and Ethics Committee Approval to the SIV. This is accomplished by having a comprehensive project plan with detailed activity and timelines wise exploded gantt charts to track each project activity and have several teams work in parallel to accomplish target timelines. These include medical writing team for quick protocol synopsis development followed by closure of Protocol, CRF, ICF and SAP within 2 weeks of project initiation, regulatory team for compiling and submission of Regulatory and IRB/IEC dossier within 2 weeks of protocol development and Clinops team for kickstarting SIV within 1 week of Regulatory Approval.

  • Fast Patient Enrolment & Contingency Planning

    Karmic compiles all patient recruitment data received by it from sites and its medical and operational experts review and apply a correction factor based on protocol inclusion/exclusion criteria and other study specific parameters to arrive at a realistic recruitment rate. This rate is exploded into a site-wise, week-wise recruitment number and becomes a critical performance metric that is tracked throughout the currency of the trial. Weekly deviations are recorded and discussed during project meetings.

    Further, for every study, there are a minimum of 30% back-up sites that are evaluated and kept on bench. If the recruitment rate is below target for 3 consecutive weeks, a decision to activate additional the back-up sites and initiate the EC process is taken by the Project Manager. Within 4 weeks the back-up site is ready for initiation. Karmic further uses in-Patient Databases, Patient Registeries, Patient Referrals, Health Check-up Camps and a host of other tools and techniques to ensure that we complete patient recruitment in stipulated timelines. We currently achieve target recruitment timelines in about 83% of our trials and want to take this number to 98%.

  • Quick LPLV to Database Lock Timelines

    As opposed to an average of 45 days for database lock from LPLV, Karmic targets database lock within 15 business days of LPLV. We have stringent data quality assurance processes to ensure CRF completion within 3-5 business days of patient visit, appropriate and timely raising of queries from data managers and monitors as well as persistent follow-up with sites for closure of queries within stipulated timelines. As the trial nears completion, we monitor the CRF and Open Queries position on a daily basis and ensure rapid closure of all queries at site so that database lock can be accomplished within 2 weeks of the LPLV.

  • Shortened Statistical Analysis and CSR Timelines through use of pre-defined templates and macros

    Karmic uses global libraries, validated macros and re-usable frameworks for quick statistical analysis as well as ICH-E9 and ICH-E3 templates for rapid turnaround of statistical analysis and clinical study reports. We are able to generate the CSRs within 4 weeks of database lock in typical studies.