Worldwide’s Clinical Assessment Training and Surveillance (CATS)
Trust your trial data with the right partner.
Quality Endpoints. Confident Decisions.
Worldwide’s Scientific Solutions Team offers a suite of unique services with the singular goal of assuring endpoint quality to maximize trial sensitivity (i.e., the ability to detect drug-placebo differences) in clinical trials across therapeutic areas. These services are a direct response to increasing trial failure rates, heightened placebo response, and growing trial complexity.
Our in-house, long-established rater training and assessment program is at the core of these services. The program’s primary objectives are to ensure proper scale administration and scoring, and to maintain continuous surveillance methodologies. This ensures accurate endpoint accrual throughout the life of the trial.
CATS services align to achieve high-quality data and endpoint assurance. They improve precision in trial planning and execution, minimize bias, and increase accuracy, empowering more confidence in study data.
With a strong scientific focus on rigorous trial methodology, the CATS team is committed to providing valid, reliable, and high-quality data that you can trust.
The CATS team has substantial experience and a dedicated and focused commitment to data quality to ensure better outcomes across our therapeutic areas of focus.
We offer differentiated services across nuanced therapeutic areas where rigorous and accurate data can become challenging, including:
Psychedelics
Psychiatry
Pain
Oncology
Neurodegenerative
Rare Diseases
Enhancing Data Quality & Reliability
Our CATS Team Structure Ensures Full Coverage
Operations
The international operational team manages the logistics of each project, including securing scale licenses, contracts, and translations.
Clinical
The clinical team is directly responsible for the quality of clinical outcomes. These services include the best approach for site, participant, and caregiver rater aid, diagnostic and symptom severity assessment, accurate reporting, and placebo response mitigation through various training modalities (e.g., direct-to-rater, Webex, or video). They also provide manual and video training to help with complicated assessments, such as those utilized in rare disease protocols or eligibility reviews.
Surveillance
The clinical team also conducts strict data monitoring through a central review of recorded assessments, source notes, and data flags. This surveillance process aims to address data quality concerns, improve rater reliability and compliance, mitigate placebo response, address site-specific issues, and, if necessary, execute targeted site or rater retraining.
Evaluation Systems
The evaluation systems division leverages the expertise of our assessment and learning management systems to advance innovative training solutions through our Virtual Learning Center and ensure high standards in managing electronic endpoint solutions.
Our Team Provides:
Expert advice and review of endpoint selection and COA identification.
We conduct rigorous reviews to identify and address data discrepancies, rater drift, and participant eligibility.
Ongoing monitoring maintains data integrity and quality and remediates any potential rater quality concerns before they impact your trial.
Our methods include comprehensive training programs for site, central, participant, and caregiver raters to ensure they follow best practices and provide extensive participant assistance for optimal protocol adherence.
Complex Therapeutic Area Expertise
Rare Disease Trials
Our experts provide specialized support to navigate the unique challenges of rare disease trials, including clinical assessments that may not have pre-determined and validated assessments specific to the disease under study. They guide raters in addressing individual nuances to keep in mind when administering and scoring assessments with the specific population, as well as custom videos to fortify functional assessments.
Psychedelic Trials
We use advanced training and monitoring to handle the distinct requirements of psychedelic research, including personalized videos, clinical interviewing training, data quality monitoring, rater trend analysis, and fully blinded central raters to enable accurate primary or secondary endpoints.
Participant-Reported Outcomes in CNS & Oncology Trials
We handle the complexities of trials that rely on participant-reported outcomes for primary and secondary endpoints. Our services ensure accurate reporting, diary compliance, and placebo response mitigation through customized participant training videos. We provide comprehensive training on placebo response and precise reporting for site staff, participants, and their caregivers. Additionally, we offer interventions to optimize participant-reported outcomes reporting and enhance the likelihood of successful trial outcomes.
Meet Your CATS Experts
Magda Perez, PhD
Senior Director, Clinical Projects
