OVERVIEW
Purpose-built for early phase oncology studies
Early phase oncology trials move fast, and every data point matters.
Regulators are increasingly emphasizing PROs in early dose-finding trials to enhance the assessment of tolerability.1 Missed side effects, delayed tolerability signals, or poor-quality data can compromise a drug’s safety profile, slow decisions, and increase regulatory risk.
eCOA Swift is built for early phase oncology trials, enabling fast, electronic capture of patient-reported outcomes to help:
Inform dosing decisions with near-real-time tolerability monitoring
Deliver timelines and budgets that are comparable to paper-based COA
Detect patient-reported symptomatic events
Capture higher-quality data in line with regulatory expectations
Why choose eCOA Swift over paper-based COA?
Superior regulatory-grade data quality
eCOA Swift supports higher-quality data capture compared with paper-based methods through:
- Time-stamped, attributable data with full audit trails
- Reduced missing data, transcription errors, and recall bias
- Reported compliance rates of 90%+ for electronic diaries compared with approximately 11% for paper diaries in a published study2
Fast setup
Set up your study in as little as 2 weeks, with timelines comparable to paper-based assessments.
Costs comparable to paper
Pricing is aligned with early phase oncology budgets and comparable to paper-based COA.
Faster, more informed decisions
Access near-real-time data on patient-reported symptomatic events, tolerability, and quality of life.
Paper may seem simpler – but it introduces delays, risks, and hidden costs that can ultimately slow your trial and jeopardize results.
Get started with eCOA Swift today and set up your study in as little as 2 weeks.
Enhance site and participant experience
eCOA Swift is designed to support a better experience for sites and participants while helping sponsors capture higher-quality data.
For sites
Fewer queries and data discrepancies
Fast site setup with reduced administrative burden
Centralized dashboard for near-real-time monitoring
For participants
Simple, intuitive interface
Automated reminders to support compliance
Flexible participation, including on-site, at-home, and a hybrid option
Backed by Clario expertise
When you choose eCOA Swift, you gain more than technology – you gain a partner.
- 25+ years of eCOA experience
- 90+ oncology eCOA-supported regulatory approvals (FDA and EMA submissions)
- Scientific and regulatory experts embedded in your study
- Deep operational expertise to help keep your trial on track
References
- FDA Guidance (August 2024) Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases
EMA Guidance (April 2016) Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man. The use of PRO measures in oncology studies - Stone A, et al. Patient non-compliance with paper diaries. BMJ. 2002;324:1193.
FAQs
What is eCOA in early phase oncology trials?
eCOA, or electronic Clinical Outcome Assessment, enables patients in early phase oncology trials to report symptoms, side effects, and quality of life digitally. Compared with paper-based COA, eCOA can support more accurate, timely, and complete patient-reported data.
What are the risks of using paper COA in Phase I trials?
Paper-based COA in Phase I trials can delay identification of patient-reported symptomatic events and introduce data quality risks, including missing data, transcription errors, and audit challenges. Nor does this approach meet regulatory ALCOA standards (Attributable, Legible, Contemporaneous, Original, Accurate), making it harder to demonstrate data quality and inspection readiness.
How does the cost of Clario eCOA compare to paper in an early phase oncology trial?
eCOA Swift is purpose-built for early phase oncology trials, with pricing designed to be comparable to paper-based COA. While total study costs vary, eCOA Swift helps avoid many hidden costs associated with paper, such as double data entry, query resolution, and shipping.
How long does it take to set up Clario eCOA Swift in an early phase trial?
Clario eCOA Swift can be set up in as little as two weeks, with timelines comparable to paper-based COA.
How does eCOA improve data quality?
eCOA can improve data quality by reducing missing data, minimizing transcription errors, and ensuring entries are time-stamped and attributable. These capabilities support higher-quality clinical outcome assessment data compared with paper-based methods.
Accelerate your early phase oncology trial with eCOA Swift
Capture high-quality patient-reported outcomes in real time with an eCOA solution designed for the unique speed, budget, and data quality needs of early phase oncology trials.