Preliminary design and analysis not appropriate for FDA regulatory approval
Rescue the study protocol and obtain reg. approval
amendment of study design, delivery of study protocol, delivery of SAP
Company was able to initiate the study in 2015 and complete it in 2016.
CE mark in Europe, application to FDA for US licence had been refused
Redesigned a series of pre-clinical and clinical studies
Innovative analysis which merged the data from software algorithm with the clinical outcomes, effective and clear reporting of results to FDA
Rescued project and secured FDA approval and license.
Umbrella study was underway and a regional study was required
Study design for regional market access
Access to extensive regional clinical network, designed an innovative study to merge diagnostics and therapeutics.
Based on the success of the regional protocol, the company decided to roll out this out for a new global study
Population based study on incidence, event rates and early outcomes in stroke patients
To make patient-outcome comparisons between Ireland and UK
Study design,rigorous and innovative analysis of standardized outcome for drug delivery and clinical practice, international publications
Led to change of standard clinical practice for treatment of stroke patients.
Respiratory Virus observational study (regional) on 2,000 neonates
Design and analysis of study results
Analysis of baseline and 1 year follow-up results, designed new global follow-up study leveraging StatisticaMedica’s US clinical network and expanded the study to include environmental health, international publications.
(1) Impact on clinical practice,
(2) Change in Pharma company's sales strategy for this vaccine at regional and international level.