Karmic: Your GLO-CAL (Global+Local) CRO Services Provider

  • Karmic's GLO-CAL (Global+Local) CRO approach

    We at Karmic have interacted and consulted several sponsors who have faced huge challenges with a global CRO model and have changed their strategy mid-way by adopting a Regional CRO approach so as to accomplish the desired results in the shortest possible time. Our value proposition revolves around the following:

    • Regional Lead CRO with partnerships across the globe to execute multi-country, multi-centric studies and ensure geographic optimization of program requirements.
    • Robust track-record of participating in and coordinating several global programs in the US, Europe and APAC.
    • Full Services development portfolio including end-to-end Pre-Clinical, Phase I to IV services.
    • Proven ability to deliver committed number of patients and execute studies on-schedule and on-budget.
    • Crunched costs and timelines, guaranteed 30% benefit over comparative global program costs.

     

  • Disadvantages of adopting the global approach

    There are several disadvantages of adopting the global approach which sometimes outweighs the benefits of consolidation:

    • Incorrect trial assumptions leading to high trial failure rate and/or rescue trials
    • Patient recruitment and study close-out delays
    • Global cost structures applied to low cost local markets
    • Non-judicious sub-contracting of work to local third parties
    • Lack of local regulatory understanding and regulatory approval delays
    • Lack of appropriate site and staff networks for trial specific requirements
    • Lack of expertise with local IP and Central Lab Management

    Sponsors looking for conducting global multi-centric trials need to question the underlying assumptions and rationale for going with a global CRO versus a regional/local CRO and do a thorough risk-benefit analysis before taking the decision. They further need to balance strategic needs pertaining to development of a local market as a long-term clinical trial destination versus the short term requirements of getting a single trial executed.