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ERT

ERT is a leading global provider of high-quality patient safety and efficacy endpoint data collection solutions for use by biopharmaceutical companies during clinical drug development. ERT delivers a combination of technology, services, and consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process throughout the product lifecycle.

By integrating innovative solutions built upon a scientific and regulatory foundation, ERT collects, analyzes, and delivers reliable safety and efficacy data critical to the approval, labeling and reimbursement of pharmaceutical products. ERT is the acknowledged industry leader in:

Multi-mode eCOA solutions, including suicide risk assessment

When it comes to capturing electronic Clinical Outcome Assessment (eCOA) – which includes Patient Reported Outcomes (PROs), Clinician Reported Outcomes (ClinROs), and Observer Reported Outcomes (ObsROs), only ERT offers all proven modalities: mobile handhelds, tablets, IVRS, and web. ERT’s technology, scientific and regulatory experts can be relied upon to help sponsors determine the most effective modality and approach for collecting eCOA data – whether through dedicated devices, Bring Your Own Device (BYOD: available on mobile apps, web, and IVRS) or a hybrid solution of both approaches.

ERT has combined scientific and regulatory expertise with these innovative technologies to deliver reliable COA consulting services and practical electronic solutions that ensure the patient’s voice is heard during new medical product development. By working with ERT, clinical trial sponsors eliminate patient compliance issues, avoid inaccurate, incomplete, or illegible data and ultimately produce better-informed data.

ERT’s proven electronic suicide risk assessment system, AVERT™ enables biopharmaceutical companies to comply with regulatory requirements for prospective monitoring of suicidal ideation and behaviors (SIB) during clinical development. ERT’s exclusive electronic self-rated version of the Columbia Suicide Severity Rating Scale (eC-SSRS) – which is available in simple audio (phone) or visual (web) formats – is a private, cost-effective and reliable method of prospectively monitoring for SIB, and is specified as an appropriate means for capturing this important data in the FDA’s revised Draft Guidance.

Scientific and regulatory consulting

ERT’s consulting group harnesses the industry-leading expertise of its cardiac safety, respiratory and COA scientific thought leaders to support the clinical development needs of biopharmaceutical researchers. ERT’s consulting group offers reliable services that support the regulatory approval and commercial optimization for new medical treatments in development.

Centralized cardiac safety

ERT’s Centralized Cardiac Safety solution utilizes newly developed software technology, within its best in class EXPERT® operating platform. The technology enables the collection of real time, consistent and high quality information, easing site operations and delivering better value to biopharmaceutical companies. Our approach focuses on the centralized collection, interpretation and distribution of ECG data and images to rule out errors from the very beginning. Significant cost savings can be recognized as a result of the improved data quality and processes associated with the use of ERT’s centralized cardiac safety solutions and services.

Respiratory solutions

ERT is the industry leader in centralized spirometry. From device customization to clinical data analysis, ERT provides products and services that ensure the most accurate data and efficient trial management in the industry. ERT’s respiratory services, now fully in the EXPERT® operating platform, offer quality control, real time views of data through a user-friendly web portal, and Best Test reviews of unacceptable data.

Universal data integration, analytics, and visualization

ERT’s innovative cloud based software platform – eClinical Insights – enables trial sponsors to integrate data from multiple systems and gain full visibility across the key aspects of their trials. This proven, cloud-based software simplifies data collection, analytics, visibility and exchange. The end result is comprehensive insight into investigative site and outcomes data activity, true risk-based management, enhanced performance measurement, and informed real-time decision-making through a single interface.

Contact us

For more information about ERT’s leading solutions visit: www.ert.com. Or contact us at:

ERT
1818 Market Street Ste. 1000
Philadelphia, PA 19103
Tel: +1 215-972-0420
Fax: +1 (215) 972-0414
eMail: eresearch@ert.com

ABPM Collection Devices

ABPM collection devices include the Mortara Ambulo™ 2400.

Mortara Ambulo™ 2400Ambulatory Blood Pressure Monitoring SystemThe Ambulo 2400 is a lightweight durable ABP monitor that is worn for 24 hours to automatically measure systolic and diastolic blood pressure, mean arterial pressure, and pulse rate during the day and night. This device can capture up to 300 measurements per battery life. The highly accurate and…

ECG Collection Devices

Products include: ELI-PC 12- Lead ECG, ELI 150, ELI 10, ELI 250, MAC 1200.

ELI 10Lightweight and ultra-portable The ELI™ 10 Rx electrocardiograph provides full-featured functionality in an ultra-portable, handheld unit designed to reduce clutter at investigator sites. High-resolution backlit LCD display provides real-time preview of 12-lead ECG and VERITAS™ interpretation results to ensure high quality data acquisition at investigator sites. ECG printing is available through a USB external…

Holter Collection Devices

Devices include: The H12+ and CardioMem®

The H12+The H12+™ 12-Lead technology Holter Recording. The H12+ digital Holter recorder provides 12-lead data recorded beat-by-beat on a compact flash memory card for up to 48 hours. A sampling frequency of 1,000 samples/sec/channel optionally provides the ability to export ECG waveforms to the Mortara E-Scribe™ Rx ECG data management system or other research programs…

Modalities

Modalities include a dedicated device, a smartphone app and IWRS.

DIARYpro® - Dedicated DeviceRemote Data Collection Using a Dedicated Device for Electronic Patient Diaries and Assessments.DIARYpro is ERT's flagship diary platform for collecting patient data remotely. First developed in 1987, DIARYpro has been used in hundreds of clinical trials and has captured data for 20 different drug approvals.DIARYpro® - Smartphone AppRemote Data Collection Using Any…

Respiratory Devices

Respiratory devices include: MasterScope® CT, FlowScreen® CT, AM3 ®, AM1+ ®, SpiroPro® CT and Clean Peak Flow Meter®.

MasterScope® CTOne platform. Multiple applications.MasterScope is a comprehensive platform for Spirometry, ECG, and home monitoring, especially designed for standardized and centralized clinical trials. A highly intuitive user interface, customized protocol workflows, and many smart features such as biometric user identification make the MasterScope the first choice for respiratory clinical trial sites around the world. MasterScope…
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