Remote Assessment

Your ability to create patient-centric, rapid-to-enroll clinical trials is critical to advancing therapeutic breakthroughs. Cogstate can help you implement a full suite of decentralized, at-home testing solutions to reduce trial risk, improve data collection, and ease patient and site burden.

We’ve assessed thousands of individuals remotely, including in global Phase II-III clinical trials. We are eager to share what we’ve learned and innovate together to help you answer important study questions.


A Suite of Remote Options to Meet Your Trial Needs

As leaders in cognitive testing, our team can help you weigh the feasibility of various remote assessment options. We have experience in all variations of virtual assessment and can offer guidance and suggestions through every step of your trial.

Brief and reliable self-administered digital cognitive assessments

Cogstate digital assessments are effective and equivalent when deployed inside or outside the clinical site. They have been utilized for in-clinic, supervised settings, and remote settings where assessment may be supervised or unsupervised.

Our tests are ideal for remote administration as they are brief, repeatable, and adapted for self-administration with online learning modules to train participants. (Fully web-based and can be accessed via tablet or PC.)

Remote administration of conventional paper-and-pencil assessments

Cognitive assessments—in conventional or eCOA format—can still be viable to conduct remotely. Cogstate has worked on delivery of multiple COAs for ‘remote-supervised’ assessment and can share lessons learned and feasible adaptations to help your research progress.

Scales delivered remotely include CDR, ADAS-Cog, ADCS-CDL, PACC, MOCA, Vineland, and many others.

Expert central raters to enhance data quality and reduce patient/site burdens

With central rating, cognitive and clinical outcome measures are administered by an independent team of highly qualified raters via telehealth (video or phone). Central raters are uniformly and regularly trained and calibrated to increase reliability, standardizations, and scoring accuracy for the clinical outcome assessments in your study.

This approach gives your sites rapid access to experienced professionals. It also allows participants to be assessed from their home, reducing site visits, and supporting faster and more diverse recruitment.

Central scoring of complex clinical measures to improve accuracy

Scoring of many clinical outcome measures can be highly manual, complex, time intensive, and error prone. In a central scoring model, assessments are completed by site raters either in-clinic or via telephone or videoconference.

Cogstate expert raters then score the assessments. Utilization of experts for centralized scoring (or score validation) can dramatically improve scoring accuracy and reduce variance, thus improving data quality.

Case Examples of Decentralized Programs in Action

Usability and Acceptability of Cogstate Digital Tests in Remote Settings

A large online registry targeting the assessment of Alzheimer’s disease utilized the Cogstate Brief Battery™. 75,491 participants completed independent, at-home tests every 3-6 months, resulting in extensive baseline (57,000) and longitudinal (28,000) data collection for the study team. Cogstate tests have high usability for the remote assessment of cognition. (Mackin et al. Alzheimers Dement 2018 Jun 21;10:573-582. Nosheny et al. Alzehimers Dement 2018 Oct 15;4:565-574. Weiner et al. Alzheimers Dement 2018 Aug;14(8):1063-1076)

Central Raters Increased Efficiency and Optimized Data Quality

The Vineland-3 is a widely used measure of adaptive functioning in rare disease clinical trials. In one program of clinical trials, 53 site raters administered the assessment; in another program of clinical trials, 7 central raters administered the assessment. An analysis of these results showed the use of central raters offered greater efficiency and optimized data quality by decreasing rater variance, while also reducing the burden on sites. (Ventola, et al, “Leveraging Remote Assessment and Central Raters to Optimize Data Quality in Rare Neurodevelopment Disorders Clinical Trials,” ECRD, 2022)

  • The team of 7 central raters conducted 150 administrations (~21 per person) compared to the 53 site raters who conducted 138 administrations (~2.5 per person).  
  • 0 of the administrations completed by the central raters had significant errors, compared to the site raters which had 4 administrations with errors that compromised the validity of the assessment.

Regulatory Landscape

Cogstate is aware of and well-equipped to work within regulatory guidelines specific to decentralized clinical trials. This includes…

FDA 21 CFR Part 11

FDA Digital Health Technologies for Remote Data Acquisition Draft Guidance

General Data Protection Regulation (GDPR)

How can we help you optimize the measurement of brain health?

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