Case Studies
Pharma Company: trial for Hypertension
Background
Preliminary design and analysis not appropriate for FDA regulatory approval
Objective
Rescue the study protocol and obtain reg. approval
Delivered
Amendment of study design, delivery of study protocol, delivery of SAP
Outcome
Company was able to initiate the study in 2015 and complete it in 2016.
Medical Device Company - UK
Background
CE mark in Europe, application to FDA for US license had been refused
Objective
Redesigned a series of pre-clinical and clinical studies
Delivered
Innovative analysis which merged the data from software algorithm with the clinical outcomes, effective and clear reporting of results to FDA
Outcome
Rescued project and secured FDA approval and license
‘Big Pharma’ – Oncology Drug – Marketed Compound
Background
Umbrella study was underway and a regional study was required
Objective
Study design for regional market access
Delivered
Access to extensive regional clinical network, designed an innovative study to merge diagnostics and therapeutics.
Outcome
Based on the success of the regional protocol, the company decided to roll out this out for a new global study
Research Hospital – Neurology unit: observational study, post-marketing - Ireland and UK
Background
Population based study on incidence, event rates and early outcomes in stroke patients
Objective
To make patient-outcome comparisons between Ireland and UK
Delivered
Study design, rigorous and innovative analysis of standardized outcome for drug delivery and clinical practice, international publications
Outcome
Led to change of standard clinical practice for treatment of stroke patients
Pediatric Clinical Practice and 'Big Pharma' - Vaccine strategy - Europe and US
Background
Respiratory Virus observational study (regional) on 2,000 neonates
Objective
Design and analysis of study results
Delivered
Delivered 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
Outcome
(1) Impact on clinical practice, (2) Change in Pharma company's sales strategy for this vaccine at regional and international level