Bracket Announces Release of “Intelligently Designed” eCOA Solution for the Vineland Adaptive Behavior Scale

WAYNE, PA  –  Bracket, a leading clinical trial technology and specialty services provider, today released a sophisticated electronic clinical outcomes assessment (eCOA) solution for Pearson’s Vineland Adaptive Behavior Scale, Second Edition (Vineland™-II), an assessment tool used to identify various special needs.

The Vineland-II is a complicated assessment that can be difficult for clinicians to administer in clinical research settings. Utilized nationwide, this tool measures communication, socialization, daily living and motor skills and maladaptive behavior in individuals from birth to adulthood. Traditionally, the Vineland-II has been administered in a semi-structured interview, via paper-and-pencil, in the form of a questionnaire.

Bracket’s Rater Station eCOA solution for the Vineland-II is helping to drive efficiencies, productivity and accuracy in the identification of various special needs by offering an electronic version of the clinical assessment. Highly interactive, the solution helps make a clinician’s time with a patient more effective.

“Pearson’s Vineland Adaptive Behavior Scale helps clinicians gain a total picture of an individual and as a result, ensuring its optimal efficiency and accuracy is vital,” said Jeff Kinell, CEO of Bracket. “By partnering with Pearson to introduce an electronic version of the Vineland-II, we aim to provide clinicians, parents and caregivers with a precise and modernized method for administering the questionnaire.”

At the forefront of digitization in clinical trials, Bracket’s eCOA version of the Vineland-II is highly customizable and includes features that make it more powerful than the classic paper-and-pencil test, including:

  • Adaptive logic that allows clinicians to only administer and score patient-specific items;
  • A prompted interview that guides a clinician through the scale; and
  • Automated scoring algorithms that reduce time and eliminate human error.

“Pearson Assessment is pleased to be associated with the high quality adaptation of one of our key products, now available to our Pharma partners,” said Paul McKeown, Director Global Licensing and Strategic Partnerships at Pearson.  “This is a great example of how we, as IP owners, can work with a leading CRO to produce a quality outcome for the sponsor and this significant piece of pharma research. Bracket is a very important associate for us in this market and we look forward to building on this work moving forward.”

About Bracket

Bracket, with seven offices and more than 500 employees worldwide, is a clinical trial technology and specialty services provider dedicated to helping biopharmaceutical sponsors and contract research organizations increase the power of their clinical research data by leveraging core competencies in Science, Technology, and Service. Bracket eCOA is a flexible platform for electronic clinical outcomes assessments. Bracket RTSM is a best-in-breed, scalable and configurable clinical IRT solution for the life sciences industry. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs. Learn more about Bracket atwww.bracketglobal.com.

Modernizing the Vineland Adaptive Behavior Scale (VABS) with eCOA

Published in 2005, the Pearson Vineland Adaptive Behavior Scale (VABS) is an assessment tool utilized nationwide to identify various intellectual and developmental disabilities, including autism. A complicated assessment that can be difficult for clinicians to administer, the VABS measures communication, socialization, daily living and motor skills and maladaptive behavior in individuals from birth to adulthood.

Traditionally, the assessment tool has been administered in a semi-structured interview that takes approximately 20 to 60 minutes to complete, via paper-and-pencil, in the form of a questionnaire.

We recently partnered with Pearson to introduce an intelligently designed electronic clinical outcomes assessment (eCOA) solution for the VABS. The electronic version will help drive efficiencies, productivity and accuracy in the identification of various special needs by featuring a variety of benefits that make it more powerful than the classic paper-and-pencil test. These features include:

2
Daily Living Skills – Personal Domain with a drop down menu displaying available responses
  • Adaptive logic that allows clinicians to only administer and score patient-specific items;
  • A prompted interview that guides a clinician through the scale; and
  • Automated scoring algorithms that reduce time and eliminate human error.

The highly interactive solution will help to make a clinician’s time with a patient more effective and aims to provide clinicians, parents and caregivers with a precise and modernized method for administering the questionnaire.

3
End of Daily Living Skills Personal Domain – Users will select the “Continue” button to proceed to the next domain

At the forefront of digitization for clinician reports, we continue to lead the charge in paper-free clinical trials and introducing an electronic version of the VABS is our latest effort in today’s mobile revolution.

For more information, read the press release or contact us today.

Bracket Randomizes First Patient Using New Integrated Precision Block Technology

Company is the first clinical IRT provider to natively integrate PBD

WAYNE, PA — Bracket, a leading clinical trial technology and specialty services provider, has randomized its first patient using Precision Block Design™ (PBD) technology integrated in its clinical IRT platform, including its mobile application. The first RTSM provider to develop and utilize the novel PBD method, Bracket is minimizing selection bias, reducing predictability of treatments and improving patient randomization by balancing known and unknown prognostic factors across comparative groups.

“The statistics group at Bracket is committed to generating the highest quality randomization lists and the development of Precision Block Design is a true testament to their dedication,” said Jeff Kinell, CEO at Bracket. “This technology ensures block patterns are uniform and we look forward to maintaining the integrity of controlled clinical studies through this innovative solution to patient randomization.”

Randomization is a core component in the design and implementation of RTSM in clinical trials and Bracket developed PBD for sponsors who want or need to utilize block pattern distribution in their randomization lists when using Bracket RTSM™. Randomization designs including those with a high number of strata or low number of slots lend themselves best to the utilization of this method.

To ensure equal representation across all permutations, PBD guarantees a uniform distribution of block patterns within each stratum. As a result, PBD does not require acceptance tests nor does it add additional time or costs to the creation of the randomization list. These benefits make PBD a win-win solution as it reduces selection bias and predictability while maintaining time and cost efficiencies.

“At Bracket, we’ve created new programming standards, crafted training, updated standard system requirements, and modified our SOPs. Maintaining the maximum level of integrity in our randomization technology is our highest priority,” said Dr. Scott Hamilton, Principal Biostatistician at Bracket.

To date, PBD has been successfully utilized by Bracket in four separate clinical trials.

About Bracket

Bracket, with seven offices and more than 500 employees worldwide, is a clinical trial technology and specialty services provider dedicated to helping biopharmaceutical sponsors and contract research organizations increase the power of their clinical research data by leveraging core competencies in Science, Technology, and Service. Bracket eCOA™ is a flexible platform for electronic clinical outcomes assessments. Bracket RTSM™ is a best-in-breed, scalable and configurable clinical IRT solution for the life sciences industry. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs. Learn more about Bracket at www.bracketglobal.com.

Visit Booth 202 During SCDM to see the Latest Technology from Bracket

The SCDM 2016 Annual Conference on September 11-14, in San Diego, CA is rapidly approaching. As the date approaches, we are excited to announce that we will be exhibiting at booth 202, and a panel discussion will be presented on Challenges to the Adoption of Bring Your Own Device in Clinical Trials by our very own, Adam Butler, Senior Vice President, Strategic Development. This panel will gather representatives from sponsors, CRO’s, and investigator sites who have already utilized BYOB to discuss what has worked, and what has not.

If you are looking to implement BYOD in your next trial or simply leverage new technologies for your RTQA, eCOA or RTSM needs, then stop by booth 202 during SCDM for more information!