Clinical Outcome Assessments/ePRO

While certain aspects of your trial may be viewed as PRO, ClinRO or ObsRO, the most important output from your trial is data. As such, we offer you the ability to design and implement clinical programs that generate the highest quality data, be it from a patient, physician or caregiver.

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CLINICAL OUTCOME ASSESSMENTS / ePRO EXPERTISE

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Supporting the best outcomes in clinical research.

ERT has combined scientific and regulatory expertise with innovative technology to deliver reliable 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, illegible or imaginary 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 modality, you can eliminate patient restrictions and compliance issues, 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 — subject, study, budget and protocol. 

CLINICAL OUTCOME ASSESSMENTS / ePRO SERVICES

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

In the quest for high-quality patient data, there are many ways to produce a good end result. This could mean utilizing multiple modalities for data collection within the same study, or more simply needing an expert recommendation of which method would be most beneficial. We understand that each study has diverse needs based on your protocol, patient population, indication limitations and other factors, and accordingly, help you create a custom solution.

Our user-friendly solutions support you in key aspects of your clinical trial, including clinical outcome assessments, monitoring and alerting, protocol design, and validation consulting. We have validated a significant number of gold standard instruments and assessments using multiple delivery methods which gives you consistency, reliability and reproducibility when collecting and analyzing these crucial clinical outcomes.

From scale and patient diary development and protocol writing or advice to multi-modality PRO, ClinRO and ObsRO solutions, we provide a full range of services in support of your clinical outcome assessments, but streamlining your data collection is not our only consideration. We are also focused on promoting patient safety throughout the clinical trial process. Increased suicidality risk with novel compounds is a growing concern, which is why prospective monitoring for suicidal ideation and behavior is now a requirement in an increasing number of drug-development efforts. We offer an electronic self-rated version of the Columbia Suicide Severity Rating Scale (eC-SSRS) — our award-winning solution providing patient-safety monitoring to identify and treat patients at risk. According to the Prospective Assessment for Suicidality Guidance, both the C-SSRS and the eC-SSRS are identified by the FDA as acceptable methods to assess patient suicidal ideation and behavior during study participation. 


GUIDANCE FOR CLINICAL OUTCOME ASSESSMENTS / ePRO

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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.

DEVICES

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Data collection. Consistent and compliant.

The biggest concerns in research for clinical endpoints are missing information, delayed entries, inaccurate data, and faulty devices. You need technology that measures what it’s intended to measure in order to promote stable, reproducible outcomes. That’s why our clinical outcome assessments/ePRO solutions are designed to standardize your data collection process, thus increasing the consistency of your data and ease of use for all stakeholders.

ERT delivers the most widely deployed products to offer a wide array of capabilities and guarantees you have the right solution for your patients, your study, and your budget. The flexibility in selecting the appropriate modality for your trial ensures you utilize the best method to obtain high-quality patient and efficacy endpoint data. Industry-leading, purpose built hand-held devices, simple electronic pens, and even device-less solutions connect your study participants to one centralized database and  improve study management across all investigator sites with easy setup and real-time data transfer. We are committed to achieving consistency in clinical outcome assessments and having built and deployed over 100,000 ePRO devices, the consistency of our data and equipment has been tested and proven. 

Our clinical endpoint equipment is delivered on time, every time to locations across the globe. In the rare event of a device malfunction 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.