Our Full Service CRO Offerings

  • Clinical Development Strategy & Consulting

    Clinical Program & Strategy Development: Karmic gets engaged right from the initiation of your product development program and supports pre-clinical and clinical strategy development leveraging a global program execution in terms of identifying various vendors, geographies and cost models (including in-licensing, out-licensing, co-development etc.) for taking your product from the Pre-IND stage to IND, Tox Package, Phase I, IIa, IIb and III.

    Regulatory Strategy Development & Consulting: Karmic’s core clinical services are delivered on a strong platform of regulatory expertise wherein we provide Regulatory Strategy & Consulting for NCEs, NBEs, Generics, Medical Devices etc. We provide end-to-end regulatory support including Pre-Approval Dossier & Documentation Support, Marketing Authorization Approval, Post Approval Support and Medical & Technical Writing services to our clients. Our team comprises of experienced regulatory consultants with 100+ person years experience and strong knowledge of US-FDA, EU-MHRA and unregulated markets.

    Pre-Clinical Strategy Development & Execution: Karmic provides a full range of Pre-clinical services to its clients using a strategic partner with an OECD/GLP compliant pre-clinical lab infrastructure with rat, mice, rabbit and guinea pigs and full PK/PD capabilities. We further support the entire Study Design and Regulatory Approval process leveraging an experienced pre-clinical team.

  • Pre-Trial

    Study Design & Pre-Study Documentation: We often start our projects with just the name of the molecule or a one paragraph long study synopsis. From there we take pains to develop and validate the Protocol Synopsis, Study Protocol, Case Report Form (CRF) and Informed Consent Form (ICF). All documentation is reviewed by our Expert Panel comprising of Medicos, Statisticians, Investigators and Operations teams before they are finalized for study initiation.

    Regulatory/EC Dossier Submission: Karmic handholds you through the Indian DCGI, IRB/IEC Dossier Compilation, Review, Submission and Approval activities to ensure smooth and timely Regulatory and EC approvals to kickstart the study.

    IP Planning & Trial Supplies Management: Karmic supports IP Management related activities including IVRS set-up, dosing calculations, IP scheduling, dispensation and monitoring at sites. We further have an in-house IP storage facility for handling trial related supplies, shipping and logistics where so required by the Sponsor.

  • During Trial

    Site Feasibility & Selection: kSiteXTM, our proprietary site feasibility model has a custom database of 1000+ sites including approximately 250 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.

    Site Initiation: Karmic has a tightly defined process for managing Site Initiations wherein a senior member of our Medical Team supports the Project Manager and CRA for the SIV which comprises of in-depth Protocol Training, ICH-GCP Training, IP Demos, Annotated SMFs etc. to ensure a comprehensive coverage of all critical study aspects.

    Clinical Trial Monitoring as per GCP: Karmic has a team of ICH-GCP/E6 trained Project Managers, Team Leaders, Clinical Research Associates (CRAs) and Clinical Trial Assistants (CRCs) with 2-8 years of field experience across key therapeutic segments and robustly defined Monitoring SOPs to ensure GCP compliant monitoring. We additionally have Independent Medical Monitors with modern medicine (MBBS) degrees deputed on key clinical projects.

    Clinical Trial Close-out: We again have established robust checklists and templates to ensure detailed review and completion of the SMF, Study Logs and resolution of all open queries before a Site Close-out.

    Clinical Data Management: Karmic has a 21 CFR Part 11 compliant CDM infrastructure comprising ClinTrial 4.6 CDMS, Inform EDC, MedDRA 13.1, WHO-DD systems as well as a trained team of Project Managers, Data Managers, Bio-Statisticians, Medical Coders and Data Entry Associates with good understanding of industry standard platforms, ICH-GCP/CFR guidelines, tools and technologies to handle end-to-end CDM requirements.

  • Post-Trial

    Bio-Statistical Analysis: Karmic offers end-to-end bio-statistical services for Phase I, PK Parameters as well as Phase II-IV studies. Karmic has expertise on leading industry software packages including SAS® 9.1.3, Winolin (PK/PD Analysis), SPSS, Minitab etc. and provide end-to-end statistical services including Sample Size Calculation, Randomization, SAP Development, Interim and Final Analysis Report.

    Clinical Study Report: Karmic has worked extensively on over 30 CSRs in ICH E3/Schedule Y formats and has pre-defined templates to turnaround CSRs in 3-4 weeks.

    CTD/eCTD Submissions: Karmic has handled 15+ CTD/eCTD submissions and has good expertise for M2 (2.4 & 2.5 Clinical/Non-Clinical Summaries), M4 and M5 compilations and knowledge searches for generic dossiers.