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 your promising drug.
Is your Clinical Development Strategy READY for Success?
Regulatory Statistics and Approval-optimization Strategies from Dose findings to Confirmatory Trials
– APPROVAL-OPTIMIZATION STRATEGIES
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.
– REGULATORY STATISTICS
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), …
Learn more on our Flexible and Innovative Approach to Clinical Study Design
Our consultants always start with the end in mind. They always strive to achieve the right balance between scientific rigor and pragmatism, as well as between state-of-the-art methodology and innovation in study design. Our toolkit includes:
IDDI’s highly skilled consultants are members of international expert committees.They have published over 950 scientific papers and are invited for lectures across the globe. They have supported more than 350 pharmaceutical and biotechnology companies, as well as academic and cooperative groups, throughout Europe, North America and Asia Pacific.