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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:
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monitoring for SIB, and is specified as an appropriate means for capturing this important data in the FDA’s revised Draft Guidance.
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.
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.
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.
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.
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