Statistical input is often critical for regulatory interactions, either to discuss specific statistical analyses or to assess statistical implications of clinical trial designs or clinical development programs. DaneStat can provide support for regulatory interactions in the following areas:
Planning for regulatory interactions
Expert statistical and drug development input to the preparation of regulatory briefing materials and responses to regulatory comments.
Participation in meetings with regulatory agencies
BENEFIT OF USING DANESTAT:
Danestat have experience of:
Participation in cross-industry, cross-functional discussions with EMA and FDA to define requirements that are both feasible and meet the needs of regulatory agencies.
Leading a cross-industry statistical consult with MHRA.
Invited panellist at FDA workshops discussing novel approaches to antibiotic development (2016) and antifungal development (2020).
Invited discussant at EMA workshop regarding the regulatory application of approaches to analysis in small populations.
Extensive experience discussing project development programs with regulatory agencies.
Experience discussing therapy area development programs with EMA and FDA.