Utilizing Medical Records as Real-World Evidence

For a Global pharmaceutical company

Project Overview

Aimed to leverage medical records data to generate evidence supporting the use of their newly developed fixed-dose combination drug over existing drugs that have been on the market for a long period.

About The Client

A Global pharmaceutical company

Case Survey

Assessing the clinical effectiveness of switching over from conventional drugs (both given as separate tablets) to newly developed fixed-dose combination drugs, in patients with T2DM

Our Solution

• Outcome measures included Change in glycated hemoglobin (HbA1c), Change in fasting blood glucose (FBG) and postprandial blood glucose (PPBG), Proportion of patients (%) reaching HbA1c target level, Difference in adherence, patient-reported measures on safety and ease.
• Designed EDC system and training to site team for data collation across 200 clinics through medical records.
• The goal of the study was to collect valid data with minimal disruption to normal care while enrolling a large generalizable proportion of the eligible population.

Business Benefits Delivered

Deemed a success, 87% of clinics/participants remained for the duration of the study, and several conclusive clinical results were attained The key findings of the assessment used to communicate the value of FDC and its use of it against the conventional mode of administration across healthcare providers (HCPs)