Customers Sharing Their Stories Here. 

Case Study: ERT eCOA Mobile Device Achieves NDA for TERISA

The objective of the TERISA trial was to evaluate the antianginal efficacy of ranolazine (Ranexa) using ERT mobile devices to collect electronic clinical outcome assessments (eCOA). The TERISA trial achieved 98% patient compliance among all 927 trial participants including a 97% compliance among the 101 trial participants who were 75 years of age or older. This is the first antianginal drug trial for type 2 diabetes patients.

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How to Implement an eCOA Strategy: A Best Practices Guide

As stakeholders, clinical trial teams and HEOR experts are viewing eCOA as the most effective way to deliver a higher quality of data, and more reliable data. This Best Practices Guide describes how biotechnology and pharmaceutical companies can leverage these efficiencies by implementing an eCOA strategy.

Case Study Evidence: Reduced Standard Deviation with Electronic PRO

Clinical researchers at Merck Research Laboratories designed a study to compare and evaluate patient-reported outcome (PRO) data collected on a handheld electronic device vs data collected on paper. To this day, the Merck Insomnia Study is widely cited as evidence for comparative equivalence and a reduced standard deviation for electronic diary data as compared to paper data.

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Celgene

Case Study: OTEZLA® Approved by FDA, EMA, Health Canada

More than 1400 patients participated in a global Phase 3 program, using two clinician-reported assessments and eight patient-reported assessments with a 99.5% effective completion rate. All electronic clinical outcome assessments (eCOA) were collected on the ERT eCOA Tablet. Pooled data from three multicenter, randomized controlled trials were analyzed to assess the efficacy and safety of apremilast, and served as the basis of approval in the US, Europe and Canada.

Customers Sharing Their Stories Here. 

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Bio Tech Insights Cloud Case Study

The challenge: a mid-sized Biotech had manual, ad-hoc reporting process that produced outdated information. The compiling information at an enterprise-level was too time-consuming to achieve. The goal was to automate data aggregation process and provide stakeholders with easily consumable trial intelligence across systems, studies, and vendors

Case Study: Centralized Data Surveillance Proactively Ensures More Than 95% Data Quality in Asthma Study

After an asthma study encountered site data quality concerns, a global sponsor relied on ERT’s Centralized Data Surveillance in their follow-up trial for better results. Learn more about this asthma study.

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Customers Sharing Their Stories Here. 

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Case Study: ERT Supports Global Sponsor to Prove Superiority of a Bronchodilator for COPD Patients Versus Existing Treatment

A leading global pharmaceutical sponsor began a program of clinical trials to discover if a new bronchodilator could demonstrate superior and sustained lung function for the long-term maintenance of airflow obstruction of patients with COPD, including chronic bronchitis and emphysema. ERT provided integrated Respiratory, eCOA, Cardiac Safety and Centralized Data Surveillance solutions for this clinical research.

Case Study: Centralized Data Surveillance Proactively Ensures More Than 95% Data Quality in Asthma Study

After an asthma study encountered site data quality concerns, a global sponsor relied on ERT’s Centralized Data Surveillance in their follow-up trial for better results. Learn more about this asthma study.

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