Clinical, Statistical and Regulatory Expert Services
Aiming at optimizing your clinical development strategy, our expert consultants develop the innovative strategies and capabilities needed to launch products with the greatest potential for commercial success and improved patient outcomes.
Comprehensive Services to Help with Your Clinical Development Strategy
IDDI’s expert consultants provide high-level strategic consulting services ranging from clinical trial design and protocol development to regulatory submission including FDA/EMA meeting representation.
CLINICAL DEVELOPMENT PLANS
Based on the available preclinical data and clinical results, IDDI help you with the strategic decisions that are required for further clinical drug development and approval of the product
IDDI offers the medical expertise, biostatistical acumen and profound knowledge of the regulatory environment that are required to design and launch clinical trials that ask the right questions regardless of the trial phase.
Validation of surrogate endpoints and of diagnostic, prognostic and predictive biomarkers
Guidance for IND and NDA submissions, biomarker approvals, pediatric exclusivity and orphan drugs designation
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