Consistent and appropriate measurement of clinical assessments is needed in order to improve understanding and evaluation of interventions. Accurately understanding and measuring anxiety, depression, rare and orphan medical conditions, and other healthcare issues is becoming more important as these conditions are prevalent in our environment. The problem is that conventional approaches frequently fail to adequately capture the whole range of symptoms, behavior and experiences that participants experience as a result of their specific diagnosis.

Valis Biosciences  is dedicated to improving the clinical trial experience for patients and sites, with a commitment to scientific rigor and passion for applying novel approaches to measurement, and brining innovative technologies into clinical trial processes. . When they observed the gaps in the system—where the requirement for precise data clashed with subjective symptoms—they made the decision to act and developed solutions that would provide researchers and clinicians with the knowledge and skills necessary to properly comprehend and treat various central nervous system (CNS) disorders. .

Valis Biosciences Inc provides clients around the world with innovative solutions that improve data quality in clinical trials, incorporating endpoint and assessment services, clinician training and assessment certification, risk-based examination of endpoint and assessment data, and video-recording, transcription, and electronic data capture technologies. Valis is committed to improving the accuracy and efficacy of evaluating symptoms in psychiatric, neurological, and rare and orphan diseases, with a primary focus on the advancement of measurement, testing and improving clinician’s understanding of assessment and data quality

Senior Management Christian Yavorsky, Ph.D., discusses the company’s fundamental goals and strategy for transforming the field of clinical trials research in CNS disorders. Recently, clinicians have begun to focus on more subjective outcomes such as quality of life, social health, pain, and patient satisfaction. The difficulty of measuring subjective symptoms is fundamental to their work.

“For example, many measurement tools have a lack of conceptual clarity and measurement feasibility and may not have been tested for reliability and validity within the specific patient population that it is being used. It is essential to define and operationalize these measurement tools. The field of clinical assessment has become more sophisticated and methodologically rigorous A good assessment tool should cover the full spectrum of behaviors that are thought to contribute to a particular disease and include a generic core and disease-specific items. Additionally, the usability of the measurement tool must be considered.” says Dr. Yavorsky.

Valis Biosciences uses a multimodal strategy to tackle this problem. In order to guarantee consistency in the administration of evaluations across various contexts and demographics, the organisation offers disease-specific extensive training programmes for professionals participating in pharmacological clinical trials, gene therapy studies, virtual reality interventions, and academic research studies. Also, they provide innovative tools designed to make data collection, data quality, and interpretation during trials easier.

Valis’s work heavily relies on the use of assessments,  that are designed to measure particular conditions. For example, clinical trials use the Montgomery-Åsberg Depression Rating Scale (MADRS) to gauge the presence and severity of depression symptoms the . However, there is irregularity in how clinicians and researchers administer, interpret and score this assessment , particularly across large-scale international trials, which can affect the outcomes of the clinical trials.

In order to address this, Valis Biosciences uses an integrated risk-based strategy that may involve two or more of the following: 1) consistency checks between and across assessments to ensure that a system is being consistently reported across assessments measuring the same construct,  2) secure 21 CFR Part 11 compliant and Annex 11 complaint closed-loop video recording system to observe clinicians’ administration skills or therapy techniques are in line with training, 3) clinician feedback and remediation for assessments conducted, and 4) central data review of clinical assessments using features within a complaint electronic Clinical Outcome Assessments (eCOA) system that allows for comparison of findings across different clinicians and assesses trends of reported results.

Valis fosters enduring relationships with pharmaceutical companies and research institutions by utilising its vast experience in the clinical trial sector. Bridging the gap between scientific rigour and technology innovation, their distinctive combination of scientific understanding and technological prowess puts them as leaders in the sector.

Valiss’s dedication to advancements in measurement and assessment in clinical trials is demonstrated by its contributions to innovative fields of inquiry (e.g., psychedelic substances, gene therapy, virtual reality and digital interventions, digital biomarkers).

Valis maintains a flat and distributive leadership model where decision-making and influence are dispersed throughout the organization and encourages a culture where each team member has a part in the success of the business. Agile decision-making and effective project execution are made possible by this methodology, which is essential for navigating the challenging field of clinical trials and regulatory compliance.

Their aim extends much beyond technology or business. It’s about people: the people battling CNS disorders and rare disorders, the medical professionals working to give the best treatment possible, and the researchers pushing the envelope of what’s feasible.

Despite Valis’s achievement, their adventure is far from ended. We can’t help but be optimistic about the future as long as they keep coming up with new ideas, working together, and supporting a more sympathetic method of measurement and assessment in clinical trials and research studies. We’re getting closer to a society in which CNS disorders, such as mental illness, and rare and orphan disorders is accepted with compassion and understanding rather than stigmatised or disregarded with Valis Biosciences leading the way.