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 and it is currently recruiting – completion date summer 2015.

Medical Device Company - UK

Background

CE mark in Europe, application to FDA for US licence 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

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.