Navigating the Path to Approval
Regulatory Statistics and Approval-optimization Strategies from Dose findings to Confirmatory Trials
Leverage IDDI Statistical Knowledge of the Regulatory Approval Process to Optimize your Clinical Development Strategy
In the ever-evolving landscape of drug development, approval-optimization strategies play a pivotal role in ensuring the success of your clinical trials and eventual approval by regulatory authorities.
We leverage the power of regulatory statistics to support our Sponsors in developing a robust statistical design that will maximize the chances of approval for their promising drug.
What is your Clinical Development Strategy?TALK TO AN EXPERT
- Streamlined Clinical Development Paths
By implementing regulatory-compliant statistical methodologies and innovative strategies, IDDI helps you with the strategic decisons and optimizes your clinical development path and reduces time to market.
- Data Quality Assurance
Robust statistical knowledge of regulatory guidances and process ensure data quality and increases the chances of regulatory approval.
- Methodologically sound and flexible trial design
Regulatory statistics is the backbone of trial design for the development of drugs, biomarkers, and devices. Regulatory bodies demand rigorous evidence to ensure the safety and efficacy of new products.
A methodologically sound trial design not only meets these stringent requirements but also enhances the credibility of data submitted for regulatory approval. IDDI’s expert consultants team helps you determine the right sample size, appropriate endpoints, and effective randomization techniques.
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. IDDI offers the medical experience, biostatistical acumen and regulatory knowledge that are required to design and launch clinical trials that ask the right questions regardless of the trial phase.
CLINICAL INPUT FOR DEVELOPMENT PLANS
Based on the available preclinical data and clinical results, IDDI helps you with the strategic decisions that are required for further clinical drug development and approval of the product.
Regulatory guidance for IND and NDA submissions, biomarker approvals, pediatric exclusivity, and rare diseases/orphan drug designation
INPUT IN LICENSING DEALS & PORTFOLIO MANAGEMENT
Validaton of surrogate endpoints, Generalized Pairwise Comparisons (GPC), …
- Adapted level of complexity (conventional, adaptive, biomarker-based design, complex & innovative designs)
- Appropriate statistical framework (frequentist, Bayesian)Optimized interim decisionsBias-mitigating methods (random allocation, sound use of real-world data (RWD) and evidence (RWE)Sample-size calculation and simulationsInput on study population, endpoints, assessments
- PK/PD analysis: Non-compartemental analysis (NCA), Population pharmacokinetics (PK), Modeling.
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Leverage IDDI’s Experience in Approval Regulatory Strategies for your next drug development.
Learn on :
- What is regulatory statistics
- What is approval-optimization strategies
- How we help our Sponsors optimize their regulatory strategy
- How IDDI guides our Sponsors to a sound statistical design that will give a promising drug all possible chances of approval
MEET THE CONSULTANTS TEAM
IDDI’s highly skilled consultants are members of international expert committees, have published over 950 scientific papers and are invited for lectures across the globe. Their advice have been sought by more than 350 pharmaceutical and biotechnology companies, as well as academic and cooperative groups, throughout Europe, North America and Asia Pacific.