DCT Consulting for Stronger Evidence

Your experts for more accurate endpoints.

A clinical trial is only as valuable as the reliability of its results. ObvioHealth’s DCT experts know how to design your trial to recruit and train the optimal cohort and root out statistical “noise”—so you get the robust evidence you need.

Poor Study Design Can Tank Your Trial’s Success

Problem: 54% of trials fail in clinical development*

Factors most likely to drive poor results are flawed study design, wrong choice of endpoint, and inadequate sample size*

*See analysis of 640 Phase III trials by Hwang et. al.

Solution: DCT expertise that powers your study for success.

Efficient and more accurate trials that take full advantage of DCT capabilities.

5 Steps to Stronger Evidence

The ObvioHealth team is made up of seasoned professionals who have deep clinical, data science, and technology expertise. Benefit from our track record of designing successful decentralized clinical trials through some or all of the following key steps.

Optimized Cohort Design

Endpoint and Outcome Selection

Instrument Selection

Patient and Expert Training

Novel Instrument Validation

Optimized Cohort Design

Ensuring more precise and efficient identification of recruitment targets.

Identify the Best Participants

ObvioHealth uses prognostic and predictive enrichment to identify participants more likely to meet your study’s requirements and achieve the targeted endpoints.

Minimize Your Sample Size

Predictive analysis can reduce the size of the sample needed to prove efficacy, making your study more efficient.

Clinical Endpoint and Outcome Selection

Merging clinical science with data science to determine the best endpoints and outcomes for a given TA and protocol.

Root Your Endpoints in Science

Our research and scientific teams conduct comprehensive reviews to ensure the identification of the most relevant endpoints for each indication.

Pinpoint the Most Meaningful Metrics

Our deep understanding of patient context allows us to identify the most sensitive metric of therapeutic intervention and ensure measures represent real-life scenarios.

Instrument Selection and Validation

Providing recommendations for instruments that are technically and clinically valid as well as user-friendly.

Select the Optimal Instrument(s)

We identify instruments, devices, and wearables that are most appropriate for the population, condition, and treatment under study.

Evaluate the Tradeoffs

We arbitrate between the reduction of patient burden and the delivery of outcomes quality, taking into consideration fatigue, usability, and granularity of data.

Multi-vital devices can make life easier for patients. But, the more things get measured, the more the quality of the data tends to suffer. Instrument selection must determine the right balance between these sometimes conflicting criteria.

Training

Reducing the bias, errors, and variability inherent in self-reporting and rater scoring.

Improve Data Quality

Patient and caregiver training reduces the biases and errors associated with self-reporting, while also mitigating placebo effect.

Keep Patients Engaged

Interactive multimedia training sets expectations and educates on best practices and how to use tools to improve data quality.

Reduce Site and Expert Rater Variability

Interactive rater training modules, created by our in-house training team, reduce inconsistencies in scoring.

Novel Instrument Development and Validation

Validating novel instruments tailored to your trial to provide more nuanced and accurate measurements of outcomes.

250+ eCOA Instruments Developed and Validated

Concept elicitation
Cognitive debriefing
Usability testing adapted for digital
Equivalence testing
Psychometric validation

The DCT Expertise You Need

  • eCOA and ePRO Experts
  • Regulatory Experts
  • Computational Biologists

ObvioHealth: Delivering Stronger Evidence

ObvioHealth launched one of the first-ever DCT platforms with a mobile app in 2017. Today, we’re a global industry leader delivering DCTs that generate stronger evidence.

91%

ePRO Compliance

89%

Retention
Average rates for ObvioHealth completed studies
Co-creating the future of clinical trials with these industry leaders.

Development and Validation of COVID-19 Symptoms ePRO Tool  

During peak COVID-19, ObvioHealth worked with Red Hill Biopharma to evaluate the safety of a new treatment for viral symptoms. ObvioHealth’s consulting team was asked to develop an ePRO tool to measure signs and symptoms of the virus remotely and thus minimize the risk of contagion from hospital visits. Successful study endpoints developed and validated through concept elicitation, cognitive debriefing, and usability testing led the sponsor to proceed to Phase III preparations.