The Strategic Consulting Partners Your Trial Needs
When it comes to strategic consulting, clinical trials demand therapeutic area experience, biostatistical acumen, and regulatory approval process knowledge. Our strategic consulting experts deliver, helping you design and launch clinical trials that ask the right questions and meet the stringent regulatory requirements of evidence.
From dose finding to confirmatory trials, count on IDDI’s strategic consulting to:
- Significantly reduce your time to market by harnessing regulatory-best statistical knowledge and pioneering methods in trial design
- Maximize your regulatory approval chances by ensuring unparalleled data quality through our profound understanding of regulatory guidance
Premium Strategic Consulting Solutions
IDDI’s suite of high-level strategic consulting for clinical trials covers everything from clinical study design and protocol development to regulatory submission and FDA/EMA meeting representation.
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Study Design
Explore Study Design ServicesFrom determining the right sample size and appropriate endpoints to randomization techniques and more, our clinical trial design services solidify your trial’s foundation and maximize the potential for your drug’s approval.
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Regulatory Statistics
Explore Regulatory Statistics ServicesOur regulatory statistics services make sure your statistical methods are scientifically sound, meet regulatory requirements, and enhance the credibility of data submitted for approval.
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Clinical Development Plan Optimization
Based on the available preclinical data and clinical results, IDDI helps you with strategic decisions regarding further clinical drug development and product approval.
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Regulatory Support
Use our regulatory expertise — spanning IND and NDA submissions, pediatric exclusivity, rare diseases/orphan drug designation, and IVD and medical device clearances and approvals — to confidently navigate your journey to approval.
Uncompromising Excellence in Drug Development Consulting Services
IDDI’s strategic consulting for clinical trials is here to maximize the chances of approval.
