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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

eClinRO

powered by Bracket’s Rater Station℠ Solution

Bracket’s Rater Station℠, an enhanced type of electronic Clinician-Reported Outcome (eClinRO), uniquely features intelligent design that provides added clinical value and quality control. The Rater Station℠ is an FDA 21 CFR part 11 and EMEA Annex 11 compliant computer device that has been used in dozens of pivotal worldwide studies.

The Rater Station℠ intelligent design 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.

Bracket’s industry-leading Rater Station℠ solution provides clients the following advancements in eClinRO services:

 

Ease of data capture at study site

Prevents missing / unreadable data

Eliminates transcription costs / errors

Instant availability of completed visit data

Built-in error trapping intelligence

Integrated audio / video capture option

Integrated scoring

Customizable per protocol requirements

FDA-preferred means of capture

Collects precise assessments across multi-site, global development programs

Accesses real-time data and reports

Identifies 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.


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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