iconLearn why sponsors choose to work with us.

We...

  • offer an interdisciplinary collaborative approach
  • carry out research studies more quickly, efficiently and effectively
  • provide close communication between the scientific and entrepreneurial world

  • Trial Design

    We know that for a study to succeed, the preliminaries must be done right beginning with a clinically relevant and expertly crafted trial design.

    Harness our expertise to:

    • Research and develop an efficient statistical design including sample size calculations
    • Perform inferential analyses to support decision-making and regulatory submissions
    • Follow through with a comprehensive analysis plan and results within 30 days of database closure
    • Produce “agency ready” reports using the most appropriate coding and metadata standards

    Result

    Expertly crafted design + rapid analysis generates timely submissions = great business sense
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    Regulatory

    Don’t burn time and money waiting for the agencies to communicate what they need -- we can show you what works and what doesn’t. Our Regulatory team has 20+ years’ experience in the research industry in the areas of regulatory strategy and quality management.

    In your next project let us help you:

    • Craft a regulatory pathway for your product and negotiate with the agencies
    • Manage Investigational Plan submissions including original IND, IDE, NDA, PMA and 510K’s
    • Maintain momentum by following up in a timely manner
    • Perform regulatory audits
    • Perform quality management system (QMS) and good manufacturing practice (GMP) assessments and end-to-end evaluation of processes

    Result

    An optimized strategy to collect the data needed to support your endpoints, while enabling you to meet both your business objectives and your obligation to the safety of study participants

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  • Project Management

    Today's product research is highly specialized and no place for generalists. With 20+ years of focused experience & expertise, we know the literature, the disease states, the standards of care, the best practices, the sites, the investigators, the opinion leaders, and the patient pools.

    We can easily integrate our services into your pre-existing plans or offer a comprehensive trial management package to maximize project efficiency.

    In your next project let us help you:

    • Develop SOPs and Project Plans
    • Configure CTMS
    • Perform site selection
    • Manage IRB approvals
    • Develop and negotiate site budgets
    • Negotiate and track reimbursement approvals with Medicare contractors
    • Perform site training and initiations
    • Manage budget accruals

    Result

    A knowledgeable and experienced partner who understands your urgency and works hard to keep you on time and on budget

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    Data Management

    Databean’s data management team all started in the trenches designing and managing clinical trials for academia and industry and are experts at configuring TrialPoint™ e-clinical solutions. If you are new to EDC, always thought it was too expensive, or don’t have the internal capacity to configure an electronic data manage system, let us help.

     

    We can:

    • Define your data requirements
    • Configure TrialPoint™
    • Perform user and server-side validation testing
    • EDC rescue – a tricky, but possible undertaking!
    • Author data management and risk-based monitoring plans
    • Source verify and perform data quality audits
    • Produce comprehensive data quality and safety reports

    Result

    An optimized, efficient, and transparent workflow in a single secure online location

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  • Post Surveillance

    The transition from clinical development to marketplace introduction is critical to the success of any product. We offer a seamless transition to post-marketing surveillance and investigator generated studies by harnessing the same tools used in your pivotal trial.

    We can easily integrate our services into your pre-existing plans or offer a comprehensive trial management package to maximize project efficiency.

    Result

    Prompt post-market deployment of studies with the same great service at much lower cost

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More experience = better results!