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CARDIAC SAFETY EXPERTISE

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It’s important to get it done right for your clinical trial.

In the world of cardiac safety solutions, data is king. We understand your need for the highest quality patient data, on time and in the correct format. To this end, we work closely with you from a data management standpoint to achieve the standards you expect in the timelines that matter. Our approach is simple: centralized collection, interpretation and distribution of ECG data and images to rule out errors from the very beginning.

Forty years of working closely with our clients and partners has taught us many things about the collection of cardiac safety data in your clinical trial. We know you will benefit greatly from a knowledgeable project manager, who will meet your expectations of experience, strong communication and, most importantly, consistency. ERT’s project managers are trained to the highest level and follow a flexible yet structured Project Assurance Methodology that produces consistent results for your trial. It’s an approach that works and supports success, evident in more than 6,000 clinical trials in which we’ve delivered high quality data on time, 99.9% of the time.

At ERT, we have international experience in over 95 countries, supporting more than 1,000-plus concurrent cardiac safety studies, more than 200 TQTs, and tens of thousands of investigation sites across the globe at any time. Beyond sheer statistics, our expertise is rooted in our services — ECG recording, transmitting, processing and reporting — as well as our commitment to metrics.

Inaccurate or inconsistent data poses the largest risk to successfully assessing the cardiac safety profile of your drug. ERT employs proven techniques to ensure you get the best quality scientific data and regularly benchmarks this output to mirror information gathered by the Metrics Champion Consortium (MCC). MCC metrics include, but are not limited to, turnaround time, query activity, shipments and data transfers, QC and QA metrics, and inter/intra-reader variability — all-in-all creating exacting standards for consistency and accuracy.

CARDIAC SAFETY SERVICES

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Our approach to cardiac safety always starts with a unique plan for you.

For every day your trial goes over its projected timeline, your costs significantly increase. Insufficient project management or inconsistent data could be the cause, but ultimately poor planning is more often than not the source of a trial gone awry. We know the importance of keeping a cardiac safety clinical trial on track and on budget, and establish project assurance by outlining everything at the very beginning of our partnership.

At ERT, we’ve built a process around a trial that gives sponsors what they need without being invasive. Whether you need cardiac safety monitoring, centralized ECG core lab services or professional consultation for clinical, scientific and regulatory considerations, our experts take a hands-on approach. We follow our methodology, acting as a seamless extension of your clinical trial staff. To start, we identify all the details: domestic and international sites, service requirements, number of transactions and logistics of reporting and data delivery. What follows is a thoughtful, interactive and repeatable process that produces the highest quality of cardiac safety data.

At the core of our strategic planning is the EXPERT operating platform – our proprietary system database that is the key to efficient cardiac safety study management and reporting, integrating cardiac safety solutions with our other service lines. With EXPERT, we are able to achieve a consistent approach across the entire clinical trial by centralizing data collection, data management and information exchange. By taking ownership of trial elements like training, reporting, quality assurance, and quality control, we are able to alleviate the workload of your site staff by streamlining and supporting the process from study start up through to data file delivery.

We’re continuously improving the services we deliver. Within our Project Assurance Methodology, an important final step is acquiring client feedback. We listen to our sponsors and act on what they have to say, effectively implementing the feedback into our overall cardiac safety plan. It’s a way for us to constantly improve our process and constantly innovate the ERT experience for our clients.

CARDIAC REGULATORY GUIDANCE

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Getting cardiac safe drugs to market.

Cardiac safety is the most common deterrent you will face in getting your drug to market as well as the number one reason for withdrawal of drugs already in market. The FDA recommends centralized cardiac safety, which means the use of a central ECG core lab with standardized and validated equipment, fewer expert readers to reduce variability and a digital database for data submission in order to be compliant.

To avoid a lengthy approval process or worse, the denial of your drug, it is imperative to comply with cardiac safety regulations and to understand your drug’s cardiac effect. In October 2005, ideas were formalized as to how the cardiac safety of new drugs is determined during clinical development. Fluent in this international guidance, we have supported hundreds of sponsors with consultation, direction, and real-time collection of consistent, quality ECG data.

CARDIAC DEVICES

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Equipment on time, every time.

The need for quality cardiac safety devices is evident, but the importance of turnaround times on those devices could be viewed as secondary. We know that clinical trial timelines call for equipment to be on time, every time. Additionally, in the event of a malfunction, you need support and assurance in recovering quickly without impacting the trial process.

ERT provides best-in-class 12-Lead digital ECG devices for standard cardiac safety and the Holter collection for our large inventory of Mortara® and GE® Healthcare ECG devices. With over 25,000 devices in the field at investigator sites in over 95 countries, our understanding of logistics on a global scale directly benefits you and your trial.

Whether your study is a single-site Phase I trial or part of a multinational Phase III program, we can accommodate your equipment needs. At ERT, we understand various country-level transmission issues and infrastructure considerations, and are therefore able to deliver the appropriate equipment and transmission solutions within your budget and timeline. The key to that management is EXPERT, which has a unique view into the sales force and inventory status to provide you with the most informed decisions about the tools you need to run your study efficiently and cost-effectively.

As part of our Project Assurance Methodology, we develop a logistics strategy in the initial investigator meeting, which means all the details regarding your devices including their programming and delivery are established upfront to reduce the risk of error further through the process. Our cardiac safety equipment delivers 99.9% on time to locations across the globe with a guarantee of a timely return in the event of a device malfunction. ERT's in-house Customer Care is available 24/7 to answer your questions or troubleshoot any issues that may arise.