Our Clinical Research Consultants provide Clinical, Statistical and Regulatory Expert Services to accelerate the development of your drug, biomarker or medical device
High-level strategic services ranging from clinical study design and protocol development to regulatory submission and FDA/EMA meeting representation.
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CLINICAL DEVELOPMENT PLANS: Based on the available preclinical data and clinical results, IDDI consultants help you with the strategic decisions that are required for further clinical drug development and approval of your product.
STUDY DESIGN: IDDI consultants have the medical expertise, biostatistical acumen, medical writing skills, and profound knowledge of the regulatory environment that are required to design and launch clinical trials that ask the right questions, regardless of the clinical trial phase. This includes developing the concept and the full protocol document, calculating the sample size for conventional, group-sequential and adaptive designs, running trial simulations, and proposing innovative solutions to optimize chances of success in the clinical trial.
ADVANCED BIOSTATISTICS: At IDDI, we have been leaders in the validation of surrogate endpoints and of diagnostic, prognostic and predictive biomarkers. We have been involved in numerous meta-analyses of individual patient data to directly or indirectly support new drug applications.
REGULATORY SUPPORT: Guidance for IND and NDA submissions, biomarker approvals, paediatric exclusivity and orphan drug designations are among the spectrum covered by IDDI consultants, who have extensive experience interacting with FDA and EMA, as well as other regulatory agencies.
Leverage IDDI deep expertise in clinical research!
