ERT has announced its ERT Knowledge Series of educational papers that discuss issues relevant to patient safety in clinical trials.
The papers focus on two of ERT's patient-safety solutions: the centralised collection and analysis of ECG data to ensure cardiac safety in clinical trials and the use of electronic patient-reported outcomes (EPRO) for suicidality monitoring in clinical trials.
ERT's cardiac safety solutions offer a centralised method of accurate ECG data collection and analysis.
Its centralised core laboratory enables the real-time collection of consistent and reliable ECG data.
Centralization minimises inconsistencies that may occur from site to site and also reduces clients' workloads.
ERT simplifies ECG data management and analysis to provide on-demand, real-time access to ECG study data.
ERT's EPRO solutions enable clients to capture sensitive findings directly from their patients.
ERT offers a fast, phone-based, voice-response solution, which is designed and optimised to help its clients collect clinically valid and sensitive data directly from participating patients.
Jeffrey Litwin's paper on ECG centralisation examines how central core laboratories are playing an increasingly important role in cardiac safety during clinical trials.
This paper demonstrates the importance of rigorous and accurate ECG data collection and analysis during clinical trials, discussing the benefits of a centralised approach to ECG collection.
A second paper, entitled, 'Is Centralization the Future for Cardiac Safety in Clinical Trials?', by Amy Furlong, looks at the importance of accurate and reliable ECG data collection and analysis.
This paper expands on Jeffrey Litwin's paper to look at the future of cardiac safety in clinical trials.
It covers the difficulty of estimating the true costs of cardiac safety, arguing the improved accuracy of digitally generated ECG data makes the centralised approach a more cost-effective option by reducing the need for re-testing.
It also discusses the need for innovative new instruments and the benefits gained by the introduction of highly compact ECG systems.
The third paper in the series, written by Michael Federico, investigates the increased risk of suicidal behaviours in patients as a result of medications.
The paper examines how EPRO plays an increasingly important role in suicidality monitoring in clinical trials.
It contrasts traditional face-to-face and paper-based methods of suicidality monitoring with electronic initiatives.
As part of ERT's Knowledge Series, a complimentary webinar entitled Cardiac Safety: Best Science, Best Value will be held on 3 February at 10am EST (3:00pm GMT) and 4 February at 2pm EST (7pm GMT).
This webinar will discuss the paradigm shift taking place in the balance between science and cost in the area of cardiac safety.
