Regulatory Strategy Support: How to optimize your clinical development strategy and reduce time to market?
Listen to IDDI’s latest podcast to discover how our regulatory support can help optimize your clinical development strategy.
Approval-optimization strategies and regulatory statistics play a pivotal role in ensuring the success of your clinical trials and eventual approval by regulatory authorities. This is where seeking expert guidance becomes invaluable. IDDI Consultants are experts in the methodological, statistical and regulatory aspects of clinical trials and have a longstanding interest in regulatory approval strategies.
Key learning objectives:
- What is regulatory statistics and approval-optimization strategies
- Why do they play a pivotal role in ensuring the success of your clinical trials and eventual approval by regulatory authorities.
- How to optimize your regulatory strategy
- How our regulatory strategy support could guide our Sponsors to a sound statistical design that will give a promising drug all possible chances for being approved.
Speakers:
- Elisabeth Coart, PhD: Director Statistical Consulting & Research, IDDI
- Everardo Saad, MD: Medical Director, IDDI
Do you need any support with your next clinical development strategy ?
- By implementing regulatory-compliant statistical methodologies and innovative strategies, IDDI optimizes your clinical development path and reduces time to market.
- Robust statistical knowledge of regulatory guidances and process ensures data quality and increases the chances of regulatory approval.
- Helping you determine the right sample size, appropriate endpoints, and effective randomization techniques, ensures your product meets the regulatory requirements of evidence.
IDDI will help you with the strategic decisions that are required for further clinical drug development and approval of the product.