Cardiovascular Monitoring/Pulmonary Diagnostics, Central Laboratory Services, Clinical Trial Design, Consulting, Data Management, Digitized QTc Analysis, Expert Reports, Medical Devices/Combination Products, Protocol Development, Spirometry/Challenge Testing
ERT is a global technology-driven provider of health outcomes research solutions and services supporting biopharmaceutical and medical device organizations to achieve their new medical product development and commercialization objectives. ERT harnesses leading technology coupled with reliable processes and scientific/regulatory expertise to collect, analyze and report on clinical trial data to support the determination of health outcomes critical to the approval, labeling and reimbursement of pharmaceutical and new medical products. ERT is the acknowledged industry leader in:
Multi-Mode ePRO Solutions
ERT has combined scientific and regulatory expertise with innovative technology to deliver multiple modalities of reliable and practical electronic solutions for capturing Clinical Outcome Assessment (COA) data (including PROs, ClinROs & ObsROs). Only ERT offers all proven ePRO modalities, including mobile handhelds, tablets, IVRS, digital pen, and web to ensure that the ideal technology is applied in each study. With unbiased consultancy in selecting the appropriate modality, you can eliminate patient compliance issues, avoid inaccurate, incomplete, or illegible data and ultimately produce better-informed data on time and on budget. Manufacturing devices designed exclusively for clinical research allow ERT’s experts to fully customize applications based on your specific needs, resulting in clinical programs that generate the highest quality data, be it from a patient, physician or caregiver.
ERT’s pioneering electronic self-rated version of the Columbia Suicide Severity Rating Scale (eC-SSRS) facilitates compliance with regulatory requirements for prospective monitoring of suicidal ideation and behaviors (SIB). The validated eC-SSRS solution, developed in collaboration with the scale’s lead author, is a cost-effective and reliable method of prospectively monitoring for suicidality, and is specified as an appropriate means for capturing this important data in the FDA’s revised Guidance on SIB.
Scientific & Regulatory Consulting
In the field of COA / ePRO consulting, ERT offers the consulting services of several pioneers in COA research. Our thought leaders will support your decision making in the creation, execution and documentation of a COA strategy to support the specific objectives, complexity, patient population and geographical coverage of your research programs. Specifically, ERT offers unmatched consulting in COA instrument development/selection/modification, paper-electronic migration, and regulatory communication/support.
Centralized Cardiac Safety 2.0
ERT's Centralized Cardiac Safety 2.0 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. As a result of the improved data quality and processes associated with the use of centralized cardiac safety, significant cost savings can be recognized, resulting in better science and improved convenience for stakeholders.
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 offer quality control, real time views of data through a user-friendly Web Portal, and Best Test reviews of unacceptable data.
For more information about ERT's leading solutions visit: www.ert.com