Calyx and Invicro are now Perceptive
Independent review of trial event assessments by adjudication experts.
Proven expertise in delivering high-quality imaging data at a global scale.
With strengths in instrument engineering, signal processing, and pharmaceutical R&D, Perceptive Discovery consistently delivers successful imaging study designs and executions.
Effective RTSM, built on 30 years of experience, and connected to an ecosystem which includes eConsent and eCOA.
Highly established imaging centers for first-in-human and multicenter trials.
900+ agents radiolabeled and counting.
Supporting both malignant and non-malignant indications.
Experts in Alzheimer’s Disease, Parkinson’s Disease imaging and more.
Supporting over 85% of radiopharmaceutical companies.
Optimize preclinical and clinical trials in other areas and drug classifications.
Therapeutic and technical expertise in imaging modalities, protocol design, and acquisition.
Oncology imaging, RTSM, and clinical adjudication services.
Tackling unique rare disease trial supply, imaging and adjudication challenges.
We are here to serve science.
From discovery, through early to late-phase clinical development, to regulatory approval and post-market, you can count on Perceptive to be dependable, diligent, and driven in everything we do.
Perceptive Discovery bridges preclinical insights to early clinical success, ensuring rigorous scientific analysis and high-quality data to support innovation.
Providing the right-fit randomization & trial supply management solution for your trials, delivered by experts.
The right people, experience, and technology to drive clinical trial imaging success.
What is eCOA?
As the complexity of clinical trials continues to increase and regulatory compliance becomes increasingly demanding, the need for precise, efficient data collection has never been more fundamental for clinical trial success. One such technology that has revolutionized the process of data collection is eCOA.
In this article, we spotlight eCOA, asking how this eClinical solution surpasses traditional paper-based methods. We also consider why the FDA strongly advocates for the collection of participant-reported outcomes, particularly in a way that promotes data accuracy, reliability, and consistency.
What does eCOA stand for?
eCOA stands for Electronic Clinical Outcome Assessment. eCOA is a technology that enables clinicians, trial site staff, trial participants, or observers, to report outcomes more efficiently and accurately. Data collected through eCOA is generally subjective in nature, COA being an umbrella term for a number of different health-related outcomes.
Clinical outcome assessments
eCOA can include many different types of clinical outcome assessments, capturing data electronically from the point of view of participants, clinicians, observers, or via performance assessments.
There are four main outcomes:
What is ePRO?
ePRO is a subset of eCOA, referring specifically to Electronic Participant-Reported Outcomes. Participant-reported outcomes are quickly becoming an integral element of clinical trials due to their ability to provide valuable insights into the participant’s experience.
While objective data focuses on measurable facts such as lab results, imaging, or clinical biomarkers, subjective insights from participant-reported data speak to the participants’ lived experiences, perceptions, and feelings toward treatment.
ePROs complement objective clinical data, offering a more comprehensive view of treatment efficacy and tolerability, ensuring that what matters to the participants being treated is factored into regulatory decision-making.
Examples of PROs
Why PROs are FDA-approved
Incorporating participant-reported outcomes into clinical trials is encouraged by the Food and Drug Administration (FDA), who provide clear guidance on incorporating such endpoints into trial design where appropriate.
Participant-reported outcomes offer a holistic view of treatment effects, enabling a better understanding of the impact of treatment from the perspective of the participant. The participants are viewed as experts in living with their disease or condition, so their perceptions are valued.
The FDA considers that participant-reported outcomes allow for a more participant-centric evaluation of new treatments, considering the real-world concerns of the participants undergoing treatment.
When collected effectively, participant-reported outcomes can be used as a basis for regulatory submission, recognized as a valid measurement of real-world treatment benefits. This is particularly important where clinical outcomes may be challenging to quantify, such as symptom relief or quality-of-life measures.
While the FDA does not endorse specific technology, it advocates for the collection of participant-reported outcomes in a scientifically sound manner to ensure the accuracy of data.
Why use eCOA in clinical trials?
The use of eCOA technology allows sponsors to evaluate the effectiveness of medical interventions while also understanding participant experience and treatment preferences.
eCOA transforms how clinical trial data is collected, replacing outdated paper methods with digital tools that not only enhance accuracy but improve compliance, making participation easier for participants and investigators.
Advantages of using eCOA:
Traditional paper-based questionnaires are replaced with electronic devices, such as smartphones, tablets, or web-based interfaces. Bring your own device (or BYOD) allows users to download a simple, intuitive eCOA interface onto their smart device, personalized to trial-specific endpoints and updated with reminder schedules where needed. eCOAs allow for real-time monitoring of participant-reported outcomes, improving data accuracy and compliance.
Given the regulatory support and the need for trial designs to be more patient-centric, the use of ePRO in clinical trials is only expected to increase.
Perceptive eClinical is more than a technology provider—we’re your trusted clinical trial ally.
Learn more about Perceptive eClinical today
Food and Drug Administration (FDA) Guidance for Industry.
Patient-reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.
Learn more about Perceptive eClinical today, or contact an eClinical solutions specialist
Resources
Food and Drug Administration (FDA) Guidance for Industry. Patient-reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.
Read More
