In drug development, the path to success is filled with challenges that require not only solutions but also strategic foresight. IDDI’s clinical research consulting team brings decades of experience and expertise in biostatistics, approval-optimizing strategies, and regulatory science to help you navigate these challenges. Leverage our knowledge and skills in regulatory statistics to ensure your products meet the stringent regulatory requirements of evidence.

Comprehensive Clinical Research Consulting Services  

IDDI’s suite of high-level strategic consulting services, ranging from clinical study design and protocol development to regulatory submission, including FDA/EMA meeting representation, is designed to infuse your clinical development strategy with unparalleled expertise.

Significantly reduced time to market by harnessing regulatory-best statistical knowledge and pioneering methods, IDDI optimizes your clinical development journey, significantly reducing time to market.

Maximize regulatory approval chances by ensuring unparalleled data quality through our profound understanding of regulatory guidance.

Maximize the potential for your drug’s approval with our clinical trial design solutions. Our consultants are adept at determining the right sample size, appropriate endpoints, and randomization techniques to solidify your trial’s foundation.

Based on the available preclinical data and clinical results, IDDI helps you with strategic decisions required for further clinical drug development and product approval.

IDDI will provide a methodologically sound clinical trial design that will not only meet rigorous regulatory demands for evidence on safety and efficacy, but will also enhance the credibility of data submitted for regulatory approval.

Our regulatory guidance spans IND and NDA submissions, pediatric exclusivity, rare diseases/orphan drug designation, and IVD and medical device clearances and approvals ensuring your journey to approval is navigated with expertise and confidence.

Leverage IDDI Statistical Knowledge of the Regulatory Approval Process

From dose finding to confirmatory trials, IDDI’s clinical research consulting team is committed to maximizing the chances of approval for your promising drug. 

Trust Your Data to IDDI

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