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Bracket Clinical Outcomes Assessment Quality Assurance

Successful clinical trials rely on accurate ratings by competent raters. Unfortunately, a rater’s clinical experience alone is not enough to ensure proper ratings administration and scoring of clinician-rated scales from trial to trial. You need a program that is tailored to the needs of your study, training raters to reach your performance expectations. Our Quality Assurance programs are designed to maximize concordance with standardized scoring conventions, maximize inter-rater and intra-rater reliability, minimize placebo response and ensure appropriate patient selection.

Why Bracket’s Rater Training and Certification?

Subjective methods of collecting research data rely on interpretation by individual research professionals. This creates the potential for variability across study sites and individuals that could result in flawed or failed studies. Avoid such discrepancies with our industry-leading rater training and certification programs.

Enhance the competency of a study’s data collection through Bracket’s customized training and validated assessment programs. Developed by Bracket’s team of therapeutic and scientific experts, get customized programs designed to reduce avoidable data variance and increase the likelihood of a clinically meaningful study.

From rater training and certification to patient education, we have developed comprehensive training materials across several multimedia platforms, providing our clients with a diverse offering of programs to meet clients’ clinical trial needs.

Why Bracket’s Quality Assurance Services?

Working in an industry that relies on the collection of data using subjective scales leaves room for inconsistencies that are often too difficult to recognize and rectify in a timely manner. Widespread issues – such as rater reliability, high placebo response rates, subject enrollment pressures and assessment variability – can contribute to a failed study.

Avoid these pitfalls with strategic and technological support from Bracket. We’ve successfully managed more than 1,200 clinical trials, ranging in size from one to thousands of sites, ten to 26,000 subjects, and we can do the same for any client. We address all aspects of clinical rating instruments and data collecting needs with proven and patented methodologies that drive endpoint reliability. Improve the quality, efficiency and accuracy of clinical research with constant monitoring, real-time feedback and guidance. With this level of transparency, clients are able to make timely decisions regarding their trials—decisions that save time, cost and stress associated with the collection of inaccurate data.

VERIFIED℠

Video Enhancement of Rater Interviewing for Independent Evaluation Data

Improve data quality and FDA compliance with Bracket’s VERIFIED℠ system. Get video and audio monitoring of study conduct and procedures and support to sites and raters throughout a study to ensure that rater interviews are performed correctly, thoughtfully and in accordance with study conventions. Our expert clinicians assist clients in reviewing each and every video to provide assurance that all is going according to plan.

Bracket’s VERIFIED℠ solution offers the following benefits:

Monitoring & Reporting

Provide continuous monitoring and timely reporting to sponsors

Consistency

Increase consistency of ratings within and across sites

Quality

Minimize trial noise

Bracket's Rater Station℠

Bracket’s Rater Station℠ is a regulatory compliant device used in dozens of worldwide studies with extensive use in central nervous system clinical trials. With an intelligent and flexible design and availability in more than 60 languages, the Rater Station℠ is an advanced eClinRO tool that improves interview quality while reducing administration and scoring errors. Outcomes can be programmed to enforce a structured interview format and can be applied to a wide range of therapeutic areas and Clinician-Reported Outcomes, in addition to electronic Patient-Reported Outcomes and Observer-Reported Outcomes. Bracket Rater Station℠ is supported by a simple training process led by a team of expert consultants.

Bracket’s industry-leading Rater Station℠ solution provides clients unique advancements in eClinRO services, including:

 

Ease of data capture at study site

Elimination of transcription costs and errors

Prevention of missing and unreadable data

Instant availability of completed visit data

Built-in error trapping intelligence

Integrated scoring and audio and video capture

FDA-preferred means of capture

Real-time data and reports access

Customizable per protocol requirements

Collection of precise assessments across multi-site, global development programs

Identification of underperforming sites and raters

Blinded Data Analytics

Bracket’s Blinded Data Analytics (BDA) represents an integral part of ensuring reliable and valid outcomes data in your clinical trial. Our BDA combines the statistical analysis of raw and derived data with rigorous clinical assessment / interpretation of the results in order to identify any areas of concern.

By allowing sponsors to identify, in near real-time, sites and raters who represent a potential risk to the quality and integrity of study data, Bracket’s BDA capabilities exceed the recommendations listed in the FDA’s “Risk Based Monitoring” guidance.

Bracket’s first-in-class Blinded Data Analytics solution offers clients critical insights into clinical outcomes data throughout the duration of the clinical trial.

  •  Unobtrusive analysis identifying potential sources of anomalous data patterns
  •  Promotes risk-based approach to data monitoring
  •  Collaborative approach with sponsor and sites to improve data quality

Learning Zone

Industry-Leading

On-Demand Training Materials
An inadequate understanding of the clinical trial by any of those involved will undoubtedly increase variability. Train your investigators, site personnel and patients to meet your study expectations anytime, anywhere with Bracket’s suite of eLearning programs and meetings. Take advantage of our industry-leading on-demand training materials and standardize your training process.

Expertly Reviewed

by Clinicians
Every program is thoroughly reviewed by our expert clinicians and available for a range of therapeutic areas, so you know you’re getting the best possible solution for your clinical trial. Ensure the collection of high-quality data with convenient, reliable and cost-effective programs from Bracket.

Bracket Learning Zone

Administer On-Demand Training Materials
Bracket Learning Zone (LMS): Administer on-demand training materials via an intuitive interface. An ideal platform for supplementing investigator meetings, delivering interim or in-study training, conducting ad-hoc training, and deploying secure, validated trainee assessments.

Subject Eligibility Validation

The C-VISA™ (Clinical Validation Inventory for Study Admission) is a customized composite inventory designed to ensure the right patients are enrolled in a trial. By incorporating information from multiple sources, we are able to verify the diagnosis, confirm symptom severity and establish subject validity for the study. Using Clintara’s proprietary software applications, and our easy to use audio/digital technology, the C-VISA™ is administered by the study rater, and reviewed independently by a Clintara clinician for confirmation. The C-VISA™ is a powerful weapon in the battle against placebo response, a leading cause of failed studies.

 

C-VISA™

Site and patient-based misincentives can contribute to inappropriate subject selection which can derail a study. Surveillance of any kind will improve subject selection. Our approach is to undertake unbiased, rater-independent assessments to identify sources of variance (e.g. misdiagnosis, insufficient symptom severity, confounding factors) that may contribute to adverse study outcomes. We think it is important that this process be collaborative, and our site-independent review procedures therefore do not adversely affect enrollment timelines, or increase work at the site level.

The C-VISA™ was created with the knowledge that “dual” rater-independent reviews for subject selection can improve study outcomes.


For more information about Rater Training and Quality Assurance, please contact our main U.S. number at 888.794.0122 or locate an area near your office.

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