Upcoming Bracket and Eisai AD Webinar: December 11th at 11am est

Join esteemed speakers Dr. Veronika Logovinsky, Executive Director at Eisai Inc., Neuroscience & General Medicine, and Dr. David Miller, Clinical Vice President at Bracket, as they present their upcoming webinar on the challenge of and need for developing more sensitive clinical outcomes in Alzheimer’s disease (AD) clinical trials, and ensuring that these clinical outcomes are administered and scored properly. The development of one such composite will be discussed. Additionally, real-world examples from recent and on-going AD clinical trials, where data quality programs were employed, will be presented.

For more information and to register, click here.

Enhancing Confidence in AD Clinical Trial Outcomes: How Composite Measures and In-Study Quality Programs Can Help Achieve the Goal
Presented by David Miller, MD, Bracket and Veronika Logovinsky, M.D., Ph.D., Eisai
Thursday, December 11, 2014
11am EDT (NA) / 3pm GMT (UK) / 4pm CET (EU-Central)
60 minutes

Bracket Releases Latest Version of Endpoint Reliability® Platform: Rater Station 3.5

Debuting at CNS Summit 2014

(Boca Raton, Florida) – Bracket is pleased to announce the release of Rater Station 3.5, our core technology platform. Rater Station 3.5 offers the advantages of a single system for management of clinical trial data collection and advanced Endpoint Reliability® solutions. Bracket’s Rater Station has been chosen by drug developers and CROs for its proven capabilities in numerous pivotal worldwide trials.

Dr. Gary Sachs, the original Rater Station inventor and now Clinical Vice President at Bracket, commented, “The latest version of Rater Station reflects over ten years of continuous improvement to the product and addresses several key sponsor needs, including Electronic Source (eSource) collection, auditable data workflow, and Blinded Data Analytics (BDA).”

Using Bracket’s proprietary electronic scale administration tool, the Rater Station’s capabilities include delivery of more than 50 diverse electronic scales. Rather than turning paper-based scales into PDF forms, Rater Station combines technology with the expertise of Bracket’s clinicians and a network of external experts to improve workflow, reduce errors, and ensure consistent scale administration.

Barbara A. Baldwin, Director of Clinical Research at Harmonex Neuroscience Research, stated, “Bracket’s Rater Station is very simple to use for both site staff and patients. Patients can easily answer scales more efficiently, which saves time during study visits. The information is effortlessly uploaded due to the ability to transfer files wirelessly, and reports are quickly sent to site staff. Bracket’s Rater Station makes collecting data from patients easy and efficient.”

Rater Station’s review, correction, and approval process allow it to be the system of record. Once the data has been transmitted back to Bracket, a team of clinicians examines the data using statistical risk-based quality metrics to identify anomalies, administration errors, and areas for concern. These issues are then discussed with the sponsor and timely remediation is initiated.

The Rater Station 3.5 also integrates with Bracket’s Blinded Data Analytics programs, which provide sponsors a visual dashboard of key study metrics and eliminates the need to comb through massive datasets to identify outliers. The dashboard brings efficiency by displaying outliers ranked by their potential to impact the quality of study data. Bracket’s clinicians help sponsors to interpret the data and provide actionable recommendations to resolve issues.

Dr. David Daniel, Bracket’s Senior Vice President and Chief Medical Officer, commented, “Bracket’s Rater Station 3.5 Clinical Trials Platform facilitates risk-based monitoring of clinical trial data for aberrant rating patterns and patient selection anomalies. Risk-based monitoring may be most effective when paired with a toolbox of Rater Station based instruments designed to enhance data quality collection, such as prompted interviews, intelligent e-scale design, and e-workbooks. Blinded data monitoring can be paired with tandem ratings or audio/video surveillance to cost effectively identify at-risk sites in global clinical trials.”

About Bracket
Bracket partners with sponsors and contract research organizations to achieve greater certainty and accurate outcomes in their clinical trials by providing a combination of scientific, technological, and operational support, from Phase 1 to post approval. Bracket’s Scientific Services target indications that are dependent on subjective endpoints (Clinical Outcome Assessments) to evaluate the safety, efficacy, and value. Bracket’s solutions have been used in more than 1,100 clinical trials across 75+ countries and 60+ languages.

Bracket’s comprehensive Endpoint Reliability® solutions include Blinded Data Analytics, Diagnostic Solutions, Electronic Scale Administration and Collection, Audio/Video Capture and Review (VERIFIED™), and a computer-based cognitive assessment system (CDR System™). Our Trial Enhancement services include Rater Training and Certification, Scale Management, and Site Selection. In addition to our scientific expertise, Bracket’s eClinical Services include Randomization and Trial Supply Management (Bracket RTSM) and ePRO technologies.

Bracket leads the specialty services field in the U.S., U.K., Continental Europe and Japan. www.bracketglobal.com.

CNS Summit 2014

CNS Summit 2014 will begin on Thursday, November 13 in Boca Raton, Florida. The Summit offers a pre-competitive environment in which industry leaders can discuss the challenges being faced in CNS research and work together to find practical solutions.

Bracket’s subject matter experts will be participating in a variety of activities at the Summit. In addition, we will be exhibiting during the Evening Receptions and will have demos of our Endpoint Reliability services on Bracket’s newly released Rater Station 3.5. We will be located at booth #1.

Thursday, November 13, 2014
8am – 5pm
CNS Summit 2014 Research Roundtable
Co-Chair: Adam Butler, Senior Vice President of Strategic Development and Corporate Marketing

Saturday, November 15, 2014
9am – 11:45am
Has it been Worth It? Data Quality Monitoring
Co-Chair: Dr. David Daniel, Senior Vice President and Chief Medical Director
Panelists: Dr. Gary Sachs, Clinical Vice President and Dan DeBonis, Principal, Endpoint Reliability Solutions

Summary of CNS Summit 2014 Research Roundtable
Co-Chair: Adam Butler

1:45pm – 2:30pm
Global Rater Certificate Database Initiative
Co-Chair: Dr. David Daniel

Poster Presentations
Poster Presentations will take place Friday and Saturday during the Evening Receptions.

Friday, November 14, 2014
5pm – 7pm
Training Implications of Identification of CDRS-R Items of Particular Challenge to Raters in Child and Adolescent Depression Clinical Trials
Dr. Joan Busner, Clinical Vice President

A Computer-Simulated Rater Administers the Primary Outcome Assessment in a Successful Acute Treatment Trial of Repetitive Transcranial Magnetic Stimulation (rTMS) for MDD
Dr. Gary Sach, Clinical Vice President and Dan DeBonis, Principal, Endpoint Reliability

Saturday, November 15, 2014
5pm – 7pm
Rater Change Associated with Identical Scoring of the PANSS as a Marker of Poor Data Quality
Dr. Alan Kott, Senior Manager, Data Analytics and Dr. David Daniel

For the full agenda, click here .