Clinical Outcome Assessments/ePRO

At ERT we understand that the most important output from your clinical trial is data. As such, we design and implement clinical programs that generate the highest quality data, be it from a patient (PRO), clinician (ClinRO) or caregiver (ObsRO).

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electronic Clinical Outcome Assessment (eCOA) Expertise

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Experience, Driven by Science

ERT has combined scientific and regulatory expertise with innovative technology to deliver reliable COA consulting services and practical electronic solutions that ensure the patient’s voice is heard during new medical product development. Capturing Clinical Outcome Assessment (COA) data (including PROs, ClinROs & ObsROs) electronically avoids errors associated with manual data entry and inaccurate, incomplete or illegible data.

At ERT, we don’t believe in a one-size-fits-all approach. We understand that your study parameters are unique and as such, you need flexibility in how your data is collected. With the most widely deployed solutions in COA and unbiased consultancy in selecting the appropriate instruments and modality, you can eliminate patient restrictions and compliance issues, and ultimately produce better data, on time and on budget.

eCOA/ePRO Solutions

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Multiple modalities for more flexible, better managed and higher quality data.

Sites Prefer ERT’s eCOA Products
At ERT we are committed to serving sites and patients and this is evident in the results of independent research. We appreciate how critical site satisfaction is when conducting clinical research and we work to make sure your sites are happy. When sites are happy, trials run smoother, patients are more compliant and you get the quality data you need faster and without hassles. 

Another key to site satisfaction is technical support. ERT’s help desk has won multiple awards for excellence in customer service and independent research shows that our Customer Care is ranked highest in the eCOA device industry. 

Finally, we place great emphasis on properly training sites, which is critical to the success of the trial. We train both in person and online and ensure staff is properly trained by testing them on their knowledge before they can enroll patients. 

Comprehensive Suite of Products
ERT has a comprehensive suite of eCOA solutions that is unmatched in the industry.  Our options include DIARYpro for remote eCOA data collection, SITEpro for site-based data collection and IVR and mobile spirometry no matter where you are located.  This breadth of options ensures you have the right solution for your patients, study, and budget.

Our COA solutions are delivered on time, every time to locations across the globe. In the rare event of a device issue, there are contingencies in place, such as the local storage of devices for quick and easy replacement. Our worldwide logistics and in-house 24-hour customer care center are always in place to support your study anywhere, at any time. 

COA Consulting

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Robust Strategies to Prove Product Value

ERT provides expertise to biopharmaceutical companies when making decisions about the strategies, instruments, implementation, and regulatory defense of Clinical Outcome Assessments (COAs) in clinical programs.

Our scientific experts are thought leaders in the industry and will support your decision making in the creation, execution and documentation of a COA strategy to support the specific objectives, complexity, patient population and geographic coverage of your research programs. This team of experts can further assist you in interpreting and applying regulatory guidance, as well as packaging evidence to support regulatory advice meetings and submissions.

We focus on the following core services:
·    COA Measurement Strategy
·    Instrument Selection/Modification/Development/Validation
·    Instrument Migration from Paper to Electronic Format
·    Regulatory and Communication Support

For more information, click here.  


Guidance for COA/PRO

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Understanding the requirements for electronic data collection.

In December 2009, the FDA issued its final Guidance on Patient Reported Outcome Measures. In doing so, the FDA clearly endorsed of the use of ePROs for the collection of patient reported data. More recently, in October 2011, the FDA conducted a public workshop to discuss measurement principles for all Clinical Outcome Assessments (COAs) used in clinical trials for new drugs – including PROs, Clinician Reported Outcomes (ClinROs), and Observer Reported Outcomes (ObsROs). As a result of that meeting, the FDA made it clear that the PRO Guidance requirements equally apply to these other types of COAs – thereby also endorsing the collection of all PROs, ClinROs and ObsROs electronically. 

Further, in January 2014, FDA issued Guidance on the Qualification Process for Drug Development Tools including a COA Qualification Program that describes a process for the advanced qualification of COAs within a specific context of use.  These guidances are designed to help sponsors as they consider, choose and/or develop, and implement their patient-focused outcome measurement strategies for clinical development.