December 1st is World AIDS Day. To bring light to the great work being done to advance HIV/AIDS research, we are highlighting BRACE (BrainBaseline Assessment of Cognition & Everyday Functioning), our technology that assesses cognition in people living with HIV.

The Clinical ink team has long had a collaborative relationship with Dr. Leah Rubin from Johns Hopkins University School of Medicine. Since 2018, we have equipped her HIV research with BRACE for use in-clinic.

Dr. Rubin is an Associate Professor of Neurology, Psychiatry, and Epidemiology and focuses on researching at-risk individuals’ cognitive and mental health. She uses big data sets to find patterns and predictors for that population, and then drills down to identify the mechanisms behind cognitive or mental decline. With a focus on people with HIV, Dr. Rubin’s work has been a part of the National Institute of Health’s Women’s Interagency HIV Study (WIHS) and Multicenter AIDS Cohort Study (MACS).

Adapting Cognitive Tests for In-Clinic Administration

Most HIV clinic visits focus on antiretroviral medication adherence, leaving patients’ cognitive and mental health forgotten. Traditionally, cognitive testing also requires a great deal of training on the part of a test administrator; even those well-trained may differ and deliver data inconsistencies. Because Clinical ink’s cognitive assessment for HIV positive people is self-administered, they remove the burden of training a test administrator AND deliver more consistent data.

Dr. Rubin says, “Being able to hand an iPad over and have [patients] complete the BRACE cognitive battery, basically [takes] away all of the burden.”

In collaboration with Dr. Rubin, the advanced technology team at Clinical ink team adapted the HAND in Hand at home iPhone app to BRACE, an in-clinic iPad app for Dr. Rubin to deploy at the John G. Bartlett HIV Practice of Johns Hopkins Hospital in Baltimore, Maryland.

“We needed some sort of electronic method that can be implemented within these busy clinics,” said Dr. Rubin. “When patients are waiting, you have 10 minutes. We can incorporate this into the busy routine of clinic care.”

Study goals

The primary goal for this study was to assess as many people as possible to understand the cognitive burden of people with HIV, and then link that cognitive data to patient medical records. Additionally, there was a desire to study the stability of cognitive function in people with HIV, because it seems to fluctuate. Because most cognitive testing is typically done at infrequent intervals, it does not allow for clear visualization of fluctuation; however, BrainBaseline’s application allows for quick, low-cost, and more frequent testing.

Dr. Rubin intended the initial BRACE protocol as a short screening tool that can flag individuals’ area of cognitive impairment. After patients are flagged, more in-depth testing can be done.

“BRACE is a nice screener for minor forms of cognitive impairment which are hard to pick up on.”

Then, Now, and Next Steps

In 2019, Dr. Rubin envisioned the BRACE data set growing into the thousands—and indeed, now in December 2022, the numbers stand at over 2,275 people enrolled. Because these cognitive assessments are more widely used in HIV clinics, cognitive decline can be better identified and quantified, which can in turn lead to the identification of underlying problems. For instance: Is HIV causing this cognitive decline, or is it the medication? Is it both? Identifying impairment can also allow for more customized treatments.

“For me it’s just about getting BRACE out there,” said Dr. Rubin. “The data will convince people. If the tool is good, the data is good … [the Clinical ink team] has developed an exceptional product.”

With mobile apps for both Apple and Android phones, at-home testing can be completed by a larger population, allowing the BRACE data set to continue to grow. We look forward to partnering to make Dr. Rubin’s vision a reality.

“[This is] the tip of the iceberg,” said Dr. Rubin. “So many amazing things that will spin off of this.”

The post Cognitive Testing for People Living with HIV appeared first on Clinical ink.

The Clinical ink Mobile Gait and Balance Assessment measures visuomotor coordination, balance, and motor performance.  It utilizes multiple sensors attached to participants to characterize biomechanical movements and identify abnormal walking patterns.^1,2

In this task, participants walk at a normal pace along a straight path, back and forth. Walking patterns are recorded from the trunk and wrist.

With the data collected, we can analyze and calculate metrics associated with gait speed, efficiency, and synchronicity, along with other disease-specific features.

Why Measure Gait and Balance?

Gait is sensitive to changes in visuomotor coordination, balance, and motor performance. Diseases affecting brain regions involved in the ability to efficiently maintain their walking pattern, volitionally control their limbs, or safely recognize and avoid hazards in their environment can negatively affect Gait performance. For example, altered Gait performance has been demonstrated in Parkinson’s disease, multiple sclerosis, and amyotrophic lateral sclerosis. ^3-5  Using Gait measurements, disease- and treatment-related changes in visuomotor coordination, balance, and motor performance can be estimated.

Discover the Additional Benefits of Clinical ink’s Technology

Learn more about how Clinical ink’s wearable and sensor technologies power the Mobile Gait Assessment, as well as other biomechanical, cognitive, and speech assessments here, or download the Clinical ink Big Brain Book, a digital assessments and endpoints catalog.

Sources:

1. Takeda, R et al (2009). Gait analysis using gravitational acceleration measured by wearable sensors. Journal of Biomechanics, 42, 223-233.

2.  Senden, R (2009). Acceleration-based gait test for healthy subjects: Reliability and reference data. Gait & Posture, 30, 192-196.

3. Latt, MD et al (2009). Acceleration patterns of the head and pelvis during gait in older people with Parkinson’s disease: A comparison of fallers and nonfallers. Journal of Gerontology, 64A, 700-706.

4. Spain, RI et al (2012). Body-worn motion sensors detect balance and gait deficits in people with multiple sclerosis who have normal walking speed. Gait & Posture, 35, 573-578.

5. Hausdorff, JM et al (2000). Dynamic markers of altered gait rhythm in amyotrophic lateral sclerosis. Journal of Applied Physiology, 88, 2045-2053.

The post Clinical ink Mobile Gait Assessment appeared first on Clinical ink.

The Clinical ink Mobile Postural Tremor Assessment measures arm stability and motor performance by measuring moment-to-moment changes in upper limb position and velocity.

Data is captured by mobile phone and smartwatch. During a baseline rest phase, participants rest their hands in their lap. During an active posture phase, participants hold their arms out, palms facing down.

Through signal processing of different frequencies, we can measure changes in upper limb position and velocity from  diseases affecting motor control as well as treatment related changes.

Why Measure Postural Tremor?

Voluntarily attempting to maintain a position against gravity is sensitive to changes in motor performance. Diseases affecting brain regions involved in the ability to maintain steady posture and arm position can negatively affect Postural Tremor performance. For example, altered performance has been demonstrated in Parkinson’s disease, multiple sclerosis, and stroke.^1-3  Using Postural Tremor measurements, disease- and treatment-related changes in motor performance can be estimated.

The Role of Clinical ink’s Technology

Learn more about how Clinical Ink’s sensors and wearables technology power the Mobile Postural Tremor Assessment and its data collection, as well as other mobility, cognitive, and speech assessments, or download the Clinical ink Big Brain Book, a digital assessments and endpoints catalog.

Sources:

1. Lance, JW, Schwab, RS, & Peterson, EA (1963). Action tremor and the cogwheel phenomenon in Parkinson’s disease.Brain, 86, 95-110.

2.  Koch, M et al (2007). Tremor in multiple sclerosis. Journal of Neurology, 254, 133-145.

3. Bansil, S (2012). Movement disorders after stroke in adults: A review. Tremor and Other Hyperkinetic Movements, 2,tre-02-42-195-1.

The post Clinical ink Mobile Postural Tremor Assessment appeared first on Clinical ink.

The Clinical ink Mobile Finger Tapping Test measures a patient’s ability to rapidly generate and coordinate rhythmic motor movements.

Participants place their index and middle fingers on the circles and rapidly tap them in alternating order. Taps completed correctly add to the “Total Taps” counter during a  dominant hand and non-dominant hand test. Performing coordinated movements requires sufficient motor control to make them consistent and repeatable.

Why Measure Finger Tapping?

Finger Tapping is sensitive to changes in visuomotor coordination and motor performance. Diseases affecting brain regions involved in the ability to generate coordinated motor movements can negatively affect Finger Tapping performance. For example, altered Finger Tapping performance has been demonstrated in Parkinson’s disease, schizophrenia, and alcoholism.^1-3 Using Finger Tapping measurements, disease- and treatment-related changes in visuomotor coordination and motor performance can be estimated.

Learn About the Benefits of Clinical ink’s Technology

Learn more about how Clinical ink’s sensors and wearables technology powers the Mobile Finger Tapping Test, as well as other mobility, cognitive, and speech assessments, or download the Clinical ink Big Brain Book, a digital assessments and endpoints catalog.

Sources:

1. Tavares, ALT et al (2005). Quantitative measurements of alternating finger tapping in Parkinson’s disease correlate with UPDRS motor disability and reveal the improvement in fine motor control from medication and deep brain stimulation. Movement Disorders, 20, 1286-1298.

2.  Carroll, CA et al (2009). Timing dysfunction in schizophrenia as measured by a repetitive finger tapping task. Brain and Cognition, 71, 345-353.

3. Parks, MH et al (2006). Brain fMRI activation associated with self-paced finger tapping in chronic alcohol-dependent patients. Alcoholism: Clinical and Experimental Research, 27, 704-711.

The post Clinical ink Mobile Finger Tapping Test appeared first on Clinical ink.

The Clinical ink Mobile Phonation Assessment measures emotional affect, voice and respiratory function.

Data from the phonation assessment is captured by phone. Participants are instructed to speak syllables such as “ahh” as long and as loud as possible within a single breath.

Why Measure Phonation?

Phonation is sensitive to changes in emotional affect, voice, and respiratory function. Diseases affecting regions of the central nervous system involved in the ability to produce or maintain phonations over an extended period of time can negatively affect Phonation performance. For example, altered Phonation performance has been demonstrated in Parkinson’s disease, amyotrophic lateral sclerosis, multiple sclerosis, and respiratory disease.^1-4 Using Phonation measurements, disease- and treatment-related changes in emotional affect, voice, and respiratory function can be estimated

Discover the Additional Advantages of Clinical ink’s Technology

Learn more about the Clinical ink’s sensors and wearables technology powers Mobile Phonation Assessments, as well as other mobility, cognitive, and speech assessments here, or download the Clinical ink Big Brain Book, a digital assessments and endpoints catalog.

Sources:

1. Tsanas, A., Little, M. A., McSharry, P. E., & Ramig, L. O. (2010). Nonlinear speech analysis algorithms mapped to a standard metric achieve clinically useful quantification of average Parkinson’s disease symptom severity. Journal of The Royal Society Interface, 8, 842–855.

2.  Ramig, LR et al (1988). Acoustic analysis of voices of patients with neurologic disease: Rationale and preliminary data. Annals of Otology, Rhinology, & Laryngology, 97, 164-172.

3. Nordio, S et al (2018). Expiratory and phonation times as measures of disease severity in patients with multiple sclerosis: a case-control study. Multiple Sclerosis and Related Disorders, 23, 27-32.

4. Tong, JY & Sataloff, RT (2020). Respiratory function and voice: The role of airflow measures. Journal of Voice.

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Central Nervous System (CNS) clinical outcome assessments — particularly Performance Outcome (PerfO) based measures — are among the most complex and nuanced assessments in neuropsychology clinical trials. Simplifying data collection for better data quality and signal detection relies on the innovative use of smarter electronic Clinical Outcome Assessment (eCOA) technology to streamline test administration and scoring, paired with expert clinical scientific guidance to design workflows. Advanced eCOA technology and expert scientific guidance enable dramatic improvements in assessment data collection. The results are more confident decision-making, more conclusive research, and faster delivery of new medicines to the patients who need them.

Positioned at the convergence of data and technology, the development of complex eCOA scales and assessments help advance clinical discovery. Clinical ink has supported more than 500 eCOA scales and assessments in 84 languages, leading the industry’s adoption of this powerful innovation. Partnering with Clinical ink in pursuit of driving endpoint data quality for CNS assessments is Cogstate Ltd (ASX:CGS), a leading neuroscience technology company specializing in the optimization of cognitive assessments to support the development of new therapeutics that provide earlier brain health insights in clinical care.

Clinical ink Principal Scientist Dr. Rinah Yamamoto sat down with Cogstate Neuropsychologist Dr. Robert McCue to discuss trends in clinical trials — and an exciting case — to illustrate where digital systems are being used to support data capture for complex cognitive assessments.

Rinah Yamamoto, Clinical ink Principal Scientist:
We’re here to talk about the use of cognitive assessments, like the Repeatable Battery for the Assessment of Neuropsychological Status, or RBANS, which are used in clinical trials research.

I know that these instruments are used in a variety of ways, from screening for inclusion to use as primary endpoints. As a neuropsychologist and an expert in neurocognition, can you provide some insight into the types of trials that monitor cognition and why it might be important for a clinical trial to be monitoring cognition in the first place?

Robert McCue, Cogstate Neuropsychologist:
Thanks, Rinah. So, there’s a surprisingly wide array of reasons to measure cognition in clinical trials. These include trials where cognition is an efficacy endpoint — either primary, secondary, or exploratory — such as in an Alzheimer’s or Parkinson’s disease trial, or those centered around other dementias, multiple sclerosis, or some rare diseases.

Cognition can also be used as a safety measure in some clinical trials, such as in cancer treatment, where quality of life factors are important for a drug that might extend life. For instance, what if such a drug extends life but causes quality of life to deteriorate? In that case, the drug might not be of as much value.

Cognitive testing is also used for inclusion-exclusion criteria, for example, if a study team wants to make sure someone has Mild Cognitive Impairment (MCI) and not dementia. Instruments can help more accurately narrow the study population down to a specific subset of participants or even segment the study into high-functioning and low-functioning cohorts. Also, if cognition declines, that might be a reason to discontinue a participant from the study if the drug may be causing it — discontinuation safety. There are a huge number of ways in which neurocognitive assessments are utilized in clinical trials.

These are all very important aspects that need to be considered when planning a trial. My guess is that there are probably many complex fit-for-purpose assessments to address each of them. Can you tell us a little bit about what makes cognitive assessment instruments so difficult to administer?

Many conventional assessments can be quite long and nuanced, including structured interviews and cognitive performance scales. Also, cognitive performance-based testing may include components that participants must utilize in the performance of the test. Many such scales are designed to be administered by skilled neuropsychologists, and it can be challenging for clinical trial sites to hire and retain such experienced, qualified raters. Oftentimes raters will come into a research site without an academic background in cognitive assessment or psychometric scales. Therefore, they may lack the hands-on supervised practice needed to refine these interviewing and testing skills. When you compound that with the fact that scales also appear, on the surface, to be simple, what happens is that raters end up really struggling when they first enter the clinical trials field.

There are a lot of other things that make cognitive assessment instruments challenging; it’s a bit like juggling. Until you actually try to juggle, you don’t realize just how difficult it is.

For example, raters must provide instructions to the participant accurately and appropriately. Using the standardized wording is critical and slight changes in the wording of the instructions to participants can have unanticipated effects on outcomes. Additionally, raters must present the test instructions with appropriate verbal pacing in order to avoid confusing participants who may have a diminished ability to rapidly process the instructions.

Raters also must respond appropriately to questions, and the participant may be confused about what you’re explaining to them. Sometimes you have to keep track of participant response time, where they only have so long to respond. And sometimes, you have tests where the rater has conditional responses that they give; they have to say something to the participant if the participant does something that meets a pre-specified condition. Those responses have to be ready to go automatically and quickly.

The rater can’t be reading the test manual during the test administration. Waiting for the rater to figure things out makes the participant’s experience far too frustrating. Additionally, sometimes there are materials that the rater has to put in front of the participant or take away or handle, like a tablet or printed materials. Or the participant has to draw, so you have to give them some paper and a pen.

It’s very much a multitasking type of experience for a rater, and I think that’s why some raters come in. If they’re good at that sort of thing, they actually learn very quickly, whereas some other raters — though they may ultimately be very good raters — really struggle at the beginning.

Sounds like it takes a lot of practice and training — and that those factors, along with monitoring inter-rater and intra-rater reliability — are critical aspects of performing these types of assessments.

Right. Central monitoring can be thought of as continued training, particularly for beginning raters. If they don’t have an academic background in psychometric or neurocognitive scales, that means they probably don’t have the kind of conceptual overview that could help them adapt to new scales more quickly. Also, supervised or monitored practice is part of clinical training in most fields. Without some type of review of the rater’s work, they miss out on a critical learning opportunity, and that can affect data quality.

So central monitoring of rater performance by expert clinicians is critical, but it’s very work-intensive — which means it tends to be costly, and it tends to be difficult for pharmaceutical companies to justify its expense.

But if the signal from the drug is going to be a small signal, then investing in things like eCOA and central monitoring can reduce variability to the point that the signal can be seen.

A good example of such a small-signal area is in Alzheimer’s disease, where you’re looking for a delay in cognitive decline over the course of the disease. This is slow with respect to the time span of a typical clinical trial.

Let’s talk a bit about the complexities involved in migrating traditional paper-and-pencil types of versions of these cognitive batteries to electronic formats. Maybe you could share a little about the practical differences between a computerized cognitive assessment, an electronic version, and a traditional paper-and-pencil cognitive assessment.

Cogstate was initially founded as an electronic cognitive assessment company. Our founders created some of the first computerized cognitive assessments specifically intended for use in international clinical trials. There are multiple advantages to an electronic assessment process: a major one being that variability between raters can be eliminated.

Cogstate computerized tests were developed from the outset to be international in the sense that the stimuli don’t need the kind of translation and localization that traditional neuropsychological tests require (where instructions tend to be very language heavy, and there’s often a lot more of the same in the process and the scoring). But the main advantage is that it really takes rater variability out of the equation, which is a huge help in achieving consistent data while potentially making clinical trials cheaper because you don’t need to train and monitor people as extensively.

So cognitive assessments come in a lot of different flavors — some that can be digitized into computer-administered tests, and then there are other more conventional assessments that are heavily reliant on rater administration with various language and cultural adaptations. When creating an electronic version of what has traditionally been a paper-and-pencil assessment, what are some of the goals?

Increasing reliability, certainly. Accuracy is probably the main thing, but there are a lot of operational considerations where an eSource really saves time and money. It saves the site a lot of work, saves the pharmaceutical company a lot of work, and saves companies like Cogstate a lot of work.

Electronic assessments allow central monitoring of studies, and they go far more smoothly with a direct data capture approach than with a traditional paper-and-pencil system because we can prevent many errors through scoring support and other validation checks. And for those errors that can’t be prevented, we can more rapidly identify when they occur, and there are certain automatic flags that tell us if it needs to be reviewed or not. If it does, we can have it reviewed by our central monitors, no matter where the site is; they can go in and electronically review written responses.

Many of our studies use audio recordings of the testing session so the monitors can listen to how the test was administered, which is often where we get most of our insights into whether the test was given properly or not. Once our reviewers have done their work, if there are findings that affect scores, they can be queried through the eSource technology platform.

Another big advantage of eCOA is that the data is already available as soon as the test is completed, as opposed to a research site having to scan documents and upload audio recordings and carry out manual data entry — an operational nightmare.

Do you have any insights on what clinical trial sponsors should be aware of when selecting to administer paper-and-pencil cognitive assessments in an electronic format? Taking something that would normally be a paper-and-pencil version, keeping the traditional form and layout, but converting it to an electronic format, and then administering it that way? What are the pitfalls? What are the things sponsors should be looking for, specifically?

Sponsors should be aware that eCOA may take longer during the initial startup process to make certain everything is absolutely right and ready to go. But after that, the cost savings and the time savings are where eCOA really starts to shine.

There are so many advantages in monitoring, even if it’s just a CRA checking GCP compliance, which is much easier. eCOA can fire off validations, which prompt the rater to go back in and fill something out that they may have accidentally left blank.

Sites appreciate not having huge stacks of study binders sitting around their offices. I recall a study where a research site in Tokyo became very upset when they received their shipment of study binders and refused the shipment because they simply didn’t have the space for these large study binders in their small Tokyo office. There are a lot of advantages that offset the slightly longer initial startup. Get it right at the start, and then it’ll go well thereafter.

We’ve really become very habituated to a digital world. I’d assume another big advantage of these electronic formats is not only not having to spend time transcribing results from paper into an electronic format but eliminating the potential risk of transcription errors.

Absolutely. That’s another job for the CRAs that is made so much easier and another job for the research sites that’s eliminated. They don’t have to take the time to write it on paper and then risk mistakes entering it into an EDC system. Data is directly entered into the system at once. So, it’s a big time and cost savings there as well.

Can you speak a little about how Clinical ink and Cogstate have worked together to develop electronic solutions for some of these paper-and-pencil cognitive assessments?

Clinical ink and Cogstate worked together on many cognitive assessments, but one recent example is implementing the RBANS, the Repeatable Battery for the Assessment of Neuropsychological Status. The RBANS is not just one test; it is a set of tests and an extensive undertaking to implement them — they all work together and are scored in such a way as to produce composite scores in several cognitive domains.

The kind of scoring that has to be done in the RBANS for this particular study protocol means the index scores and the total overall RBANS score both have to be derived using normative data. That’s something that clinical trial raters don’t typically do, and it can be complex and error-prone for neuropsychologists who do this every day. It’s doubly so for raters with no background in deriving standardized scores.

Because I have some background in software programming, I was impressed by how smoothly the development of the scoring went. From our initial pilot testing onward, the index scores were computed accurately.

Given the importance of the RBANS total score in this protocol, this scoring automation will be hugely helpful to the success of the study.

We’d like to thank Dr. McCue for his time and valuable perspective. Cogstate and Clinical ink have a long-standing collaboration jointly supporting CNS eCOA instruments.

Find out more about how our eCOA technology can help.

Read our eCOA solutions Fact Sheet or contact us to learn more.

The post Use of Advanced eCOA Technology Streamlines Complex Neuropsychological Assessment: RBANS® appeared first on Clinical ink.

Clinical ink’s platform uniquely supports the needs of sponsors working on Alzheimer’s trials by:

• Using direct collection tools that allow for flexible data collection options (site-based, home-based, and remote), which are critical for studies that involve contraindicated patient populations.
• Providing an integrated review of patient data progression, allowing for subtle changes in patient status can be monitored in real time.
• Including cognitive batteries, coupled with clinical outcome assessments, all on one device — enabling quality and speed.
• Delivering data to clinical research professionals in near real time, enabling timely actions in support of patients and early insights into the study data.
• Supporting at-home collection for patients via provisioned devices or bring your own device (BYOD) — the use of a patient’s own smartphone — for improved compliance and better patient experiences.
• Providing expert caregiver support for at-home patient diary solutions, which feature easy-to-follow workflows and simplified implementation.

Clinical ink’s work with the Alzheimer’s Clinical Trials Consortium (ACTC) has added to the company’s expertise, above and beyond its wealth of real-world protocol experience. Clinical ink’s proactive engagement of the multiple stakeholders it takes to build a superior tool that supports the complexities of Alzheimer’s trial conduct and data collection — including the ACTC and real-world patients — has resulted in technology that is as easy to use as it is robust.

Clinical ink CEO Ed Seguine, previously a founding manager of the Eli Lilly & Co. venture capital funds, e.Lilly, and Lilly Bioventures, said, “Alzheimer’s is an especially complicated and challenging therapeutic area in which to conduct a clinical trial. Clinical ink’s Lunexis eSource platform is custom-tailored for exactly such indications, enabling virtual and hybrid models driven by direct data capture. We’ve been pleased to work on therapies and devices offering such promise.”

About Clinical ink
Clinical ink, a global clinical technology company, offers data certainty from source to submission. Our Lunexis eSource clinical technology and configurable direct data capture, eCOA, ePRO, and eConsent modules — a suite of solutions for capturing and integrating electronic data from sites, clinicians, and patients at its source — naturally enhance your clinical trial workflow by reducing manual labor, providing anytime, anywhere data access, and saving resources as your trials progress.

The post Clinical ink Adds 16th Concurrent Alzheimer’s Study Supporting 9,000+ Patients Across 25 Countries appeared first on Clinical ink.

“Our goal is to transform the entire rater experience with process-enabling technologies that lead to better assessments, so a partnership with the eSource pioneers at Clinical Ink was the clear choice for advancing that objective”, commented Cogstate CEO, Brad O’Connor. “This is one solution from two market leaders, so it is very much aligned to the ‘best-of-breed’ approach that many sponsors are taking for their outsourcing strategies; particularly in the area of CNS where signal detection is so challenging and endpoint quality assurance is so critical.”

“The benefits of eSource for CNS research are dramatic,” stated Ed Seguine, CEO, Clinical Ink. “Combining Cogstate’s therapeutic expertise with our SureSource® platform, which directly captures data in the moment during the patient visit, promises to improve protocol execution. Researchers can focus more attention on the patient and the ratings when workflow and scoring are automated. This is an incredible time for CNS research and Clinical Ink is delighted to partner with a therapeutic leader like Cogstate on this advancement.”

This joint solution delivers important advantages to sponsors seeking to transcend traditional paper-and-pencil assessment scales in their clinical trials, including:

• Custom edit checks, programmed workflows, and automated scoring at the point-of-care that prevent clerical errors and miscalculations
• Same day access to quality source data and documents for central monitoring by Cogstate’s network of local expert advisors (LEADs), with custom flagging algorithms designed by clinical scientists for rapid identification of rater variance
• Rater training that reaches beyond the investigator meeting and eLearning platforms by elegantly incorporating rater guidance directly into the rating scale instrument used during the patient visit for more accurate, standardized administration

A growing library of enhanced electronic scales ready for study-specific licensing and protocol customization
Key Learnings from a recent multi-site study will be presented in a live educational webinar, taking place November 9th at 11:00 a.m. EST.

About Cogstate

Cogstate Ltd (ASX:CGS) is a leading cognitive science company dedicated to simplifying the measurement of cognition in clinical trials, academic research and healthcare. Cogstate provides expert support for traditional neuropsychological and functional assessments to drive higher quality measures, and commercializes rapid, reliable and highly sensitive computerized cognitive tests. Cogstate customers include the world’s leading biopharmaceutical companies; military and elite sporting organizations; physicians and patients; renowned academic institutions and public-private partnerships.

Media Contact: Rachel Colite | 203.773.5010 | rcolite@cogstate.com

About Clinical Ink

Clinical Ink is a global clinical trial technology company that is transforming the clinical trial experience. Founded in 2007, the Company’s proven and future-built eSource platform, which includes solutions for EDC replacement, eCOA, ePRO and more, accelerates time to value while delivering scientific results that matter. With offices in Winston-Salem, NC, and Philadelphia, PA, Clinical Ink is advancing the business model responsible for bringing new treatments to market.

Media Contact: Jessica Romero | 336.728.6541 | jessica.romero@clinicalink.com

The post Cogstate and Clinical Ink Deliver Enhanced Tablet-Based eCOA for CNS Clinical Trials appeared first on Clinical ink.