Bracket Introduces Transformative IRT Solution, CUBE™, to Biotech and Pharma Sponsors

WAYNE, Pa — Bracket, a leading clinical trial technology and specialty services provider, announced today the release of CUBETM, a transformative interactive response technology (IRT) solution for the life sciences industry. Designed through an iterative user acceptance build experience, CUBE will be immediately available to qualifying biotechnology and pharmaceutical trial sponsors through Bracket.

The solution will enable biotech and pharma sponsors to utilize an innovative new solution to deploy studies in one to two weeks. It leverages an iterative user acceptance build experience to provide a rapid and advanced deployment methodology without the time and cost constraints of traditional IRT solutions. Key highlights of CUBE for biotech and pharma sponsors of any size include:

  • Accelerate times for sponsors and improves efficiency for CROs
  • Leverages Bracket’s full RTSM platform, but streamlines deployment through automation
  • Rapid project lifecycle lets sponsors experience the system prior to requirements approval
  • Reduce lengthy turnaround times for enhancements and in-study changes

“We’re so pleased to introduce CUBE to the life sciences marketplace and are confident that its easy-to-implement nature will improve the process of managing clinical supplies,” said Jeff Kinell, CEO at Bracket. “By deemphasizing requirement documents and prioritizing unique configuration needs, CUBE will undoubtedly evolve the paradigm of how sponsors collaborate to deploy IRT.”

The platform’s iterative UAT process allows study teams to visualize the RTSM system during the kick off meeting. This accelerates timelines for sponsors and improves efficiency for CROs. CUBE also leverages Bracket’s full RTSM platform, but streamlines the deployment of configuration profiles through automation. It’s intended to support most trial design constructs.

For more information, please visit www.bracketglobal.com/CUBE/.

About Bracket
Bracket, with nine offices and more than 700 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 SmartSupplies™ is a proven platform for improving a clinical supply chain. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs.

Bracket Announces Launch of Cloud-Based Version of SmartSupplies

Wayne, Pa — Bracket, a leading clinical trial technology and specialty services provider, today announced the launch of a cloud-based service for SmartSupplies, its clinical trial inventory management software suite. This launch marks the first hosted solution of SmartSupplies since Bracket’s acquisition of CLINapps in 2016 and is applicable to all modules of the SmartSupplies suite.

SmartSupplies, an enterprise clinical trial material management software solution, provides end-to-end clinical inventory management for sponsors. The release of the cloud-based offering will enable companies without their own IT infrastructure and servers to easily and securely run and manage the application. Built atop Oracle Cloud Services, the cloud-hosted solution will facilitate enhanced integration with other eClinical systems as well as allow end users and clinical research associates (CRAs) to share data seamlessly and instantaneously without geographic constraints.

“We are pleased to introduce a cloud-based hosting option for SmartSupplies to our existing and new customers,” said Jeff Kinell, CEO of Bracket. “The benefits of cloud hosting continue to present themselves, especially as clinical trials worldwide rely more on immediate collaboration across sites.”

Bracket’s hosted SmartSupplies solution is competitively priced and provides a cost-effective alternative for sponsor companies deploying the enterprise solution. This cloud-based option allows sponsors to eliminate in-house hardware maintenance and management for a reduced IT footprint.  Other advantages include:

  • Reducing outsourced hosting, off-shore contractors and vendors for decreased third-party costs;
  • Enabling proactive support and system health-checks from Bracket’s support team;
  • Facilitating better integration with other eClinical systems and collaboration across sites; and
  • Ensuring a well-maintained regulatory environment and robust business continuity.

The transition of SmartSupplies to the cloud is seamless for existing customers, causing no disruption to the end user.

“Offering customers the option of cloud hosting for SmartSupplies was born out of necessity,” said Kinell. “We want sponsors to focus their energy and efforts on running clinical trials, not on managing their IT infrastructure – and hosting SmartSupplies in the cloud will alleviate that burden.”

About Bracket
Bracket, with nine offices and more than 700 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 SmartSupplies™ is a proven platform for improving a clinical supply chain. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs.

Bracket Among the First Providers to Initiate BYOD ePRO Clinical Research Study in Japan

Wayne, Pa —Bracket, a leading clinical trial technology and specialty services provider, today announced the launch of a new Bring Your Own Device (BYOD) electronic patient-reported outcome (ePRO) study in Japan.  This study highlights the importance of BYOD use in clinical studies as an integral component of electronic clinical outcomes assessments (eCOA). Bracket is among the first to utilize BYOD in a randomized clinical trial in Japan.

The use of BYOD in clinical research is the next crucial stage in continuing to embrace the technology that has fundamentally improved the way studies are conducted. BYOD adoption is slowly gaining momentum, but the many ways it has enhanced the effectiveness of clinical research serve as an argument for why mobile support should become an essential element of other eCOA platforms.

Bracket’s own next-generation platform, Bracket eCOA™, integrates with several devices to support ePRO, eClinRO and eObsRO use, supplementing a BYOD approach. Allowing patients to collect and report data in a central location through easy-to-use mobile applications increases patient engagement and improves data quality.

“eCOA is an extremely important research tool and the increasing adoption of BYOD is highly beneficial for the industry on a global scale,” said Jeff Kinell, CEO at Bracket.

Bracket Patient Diary is a native app that allows patients in clinical trials to use their own smartphones to complete questionnaires about their symptoms, medication use, and quality of life. Bracket Patient Diary has been in use in clinical trials since 2014 and is available for Android and iOS.

About Bracket
Bracket, with nine offices and more than 700 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 SmartSupplies™ is a proven platform for improving a clinical supply chain. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs.

Bracket to Develop Electronic Versions of MDS-UPDRS and UDysRS for Parkinson’s Disease Trial Assessments

Wayne, PA., — Bracket, a leading clinical trial technology and specialty services provider, today announced an agreement with the International Parkinson and Movement Disorder Society (MDS), to develop electronic versions of the MDS-Unified Parkinson’s disease Rating Scale (MDS-UPDRS) and the Unified Dyskinesia Rating Scale (UDysRS). The migration of these complex scales to an electronic clinical outcome assessment (eCOA) format aims to improve trial conduct and data quality for Parkinson’s disease (PD) studies.

The increasing prominence of PD, a progressive disorder of the nervous system that affects movement, drove MDS to prioritize the update of its scales. Today more than 10 million people worldwide are living with the condition, and each year 60,000 people are newly diagnosed in the United States alone.

Bracket has extensive experience working with paper-and-pencil clinical outcomes in Parkinson’s disease and other movement disorders. Bracket is creating eCOA versions of the MDS-UPDRS and UDysRS to support efforts to improve data quality in these studies. Both scales require careful clinical interviews of patients, and by migrating these instruments from paper records to eCOA platforms, investigators and pharmaceutical sponsors will be equipped with a more effective method for using these outcomes in clinical trials.

“Clinical trials in Parkinson’s disease and other movement disorders are extremely complex and have a high failure rate,” said Jeff Kinell, CEO of Bracket. “Fortunately, digitization in clinical trials is improving results, as the logic of eCOA streamlines scoring protocols and compliance. We’re proud to partner with MDS to advance PD trials and help address the growing prevalence of the disease at the ground level.”

The UPDRS was developed in the 1980s and is the most widely used rating scale for PD in clinical trials. The revision, known as the MDS-UPDRS, was released in 2008 and measures mentation, behavior and mood, activities of daily living and motor functions. The UDysRS evaluates involuntary movements associated with treated PD, measuring on-dyskinesia, off-dystonia, impairment and disability.

The MDS-UPDRS and UDysRS scales are prime candidates for digitization as eCOA will streamline specific trial protocols, including the addition of time stamps associated with administration to ensure scales are administered appropriately. Additionally, eCOA will simplify calculations on how much time subjects report experiencing dyskinesia, dystonia and an “off” state.

About Bracket
Bracket, with nine offices and more than 700 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 SmartSupplies™ is a proven platform for improving a clinical supply chain. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs.

Bracket Welcomes Jennifer Peters as Senior VP and General Manager to Scientific Services

WAYNE, PA — Bracket, a leading clinical trial technology and specialty services provider, today announced the addition of Jennifer Peters to its growing team as the Company’s new Senior Vice President and General Manager for the Scientific Services division. In this role, Ms. Peters will be responsible for Bracket’s work in Rater Training, Quality Assurance, and Electronic Clinical Outcomes Assessments (eCOA.) Ms. Peters joins Bracket with a strong skillset and demonstrated record building technology-based businesses in life sciences.

With more than 14 years of life sciences industry experience, Ms. Peters most recently served as a Founder and Chief Experience Officer of Greenphire, a global provider of disruptive clinical trials payment and process optimization technology products serving pharmaceutical sponsors, biotech companies and CROs. She led Greenphire from an idea-stage startup, with three founding employees at its inception in October 2007 to a global technology enterprise with more than 100 employees and 500+ clients when it was sold to a private equity firm in 2014.

“We’re very fortunate to have someone with Ms. Peters’ background join our senior leadership team at a time when we are experiencing solid growth due to the adoption of technology and deployment of proprietary methodologies,” said Jeff Kinell, CEO at Bracket. “Our growth has created the need to be innovative in both the way we’re organized and the way we deliver on our commitments to clients. We are confident that Ms. Peters will bring fresh ideas to help lead us to continued success.”

Prior to her tenure at Greenphire, Ms. Peters held a series of progressively senior leadership positions beginning in 2002 at Transperfect Translations, a global provider of translation services and localization technology to clinical trial sponsors and CROs.

Ms. Peters holds a Master’s of Science degree from Pace University and will be based in Bracket’s Wayne, PA headquarters.

About Bracket
Bracket, with nine offices and more than 700 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.

Bracket Welcomes Clinical Vice President Lewis Fredane, MD to Global Team

Wayne, PA – Bracket, a leading clinical trial technology and specialty services provider, announced the addition of Clinical Vice President Lewis M. Fredane, MD to its global team. A board certified neurologist with more than 30 years of clinical research experience, Fredane brings a strategic combination of clinical and industry research expertise to his new role.

As Clinical Vice President, Dr. Fredane will serve as the Therapeutic Area Leader for neurology and will oversee Bracket’s eCOA, Rater Training, and Quality Assurance work in this important therapeutic area.

“Neurology, especially neurodegenerative and developmental disorders are a critical focus for Bracket and Dr. Fredane’s impressive background and experience will be instrumental to our progress in these areas,” said David G. Daniel, MD, Senior Vice President and Chief Medical Officer at Bracket.

“We look forward to the knowledge and leadership Dr. Fredane will bring to Bracket and warmly welcome him to the team.”

Prior to joining Bracket, Dr. Fredane served as a practicing neurologist and clinical assistant professor of Neurology at Drexel University College of Medicine in Philadelphia, Pennsylvania. He has worked in pharmaceutical drug development at several companies including at Sanofi/Genzyme Pharmaceuticals, Meda Pharmaceuticals and with CRO Omnicare Clinical Research. He also maintains extensive experience in medical affairs and has published research on multiple sclerosis, pain management and transplantation.

“I am so pleased to join the esteemed Bracket team and combine my diverse experience in neurology with the global platform, innovative tools and intelligence already set forth by this organization,” said Dr. Fredane.

Dr. Fredane received his medical degree from Albert Einstein College of Medicine and completed his training with a residency in Neurology at Duke University. He completed fellowships in Clinical Immunology at St. Luke’s-Roosevelt Hospital Center in New York and in Immunology at Yale University School of Medicine in New Haven, Connecticut through a research fellowship with the National MS Society.

About Bracket
Bracket, with nine offices and more than 700 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.

Bracket’s New SAB Sub-Committee for Alzheimer’s Disease to Hold Inaugural Meeting at CTAD 2016

WAYNE, PA- Bracket, a leading clinical trial technology and specialty services provider with expertise in Alzheimer’s disease (AD), announced that its Scientific Advisory Board (SAB) has formed an AD sub-committee that will hold its inaugural meeting at the 9th Annual Clinical Trials on Alzheimer’s Disease (CTAD) conference on December 8 – 10, 2016 in San Diego, California.

The sub-committee, chaired by and established in collaboration with Jeffrey Cummings, M.D., Sc.D., Director of Cleveland Clinic’s Lou Ruvo Center for Brain Health and Camille and Larry Ruvo Chair of the Neurological Institute of Cleveland Clinic, will focus exclusively on maintaining Bracket’s awareness and involvement in AD research advancement, field changes, emerging technologies and competitive landscape.

As a specialty services provider with specific expertise in AD trial technology, including the development and launch of Bracket eCOASM, Bracket’s sub-committee will build upon the Company’s strategic agenda to capture data using technology, finding innovative ways to minimize error-prone human factors in clinical trials. The committee will be critical in assessing the acceptability of new technologies to sites.

“Bracket’s SAB is well-represented across various therapeutic areas, but we maintain a specialized focus on AD in effort to combat the many challenges facing its clinical trials today,” said Jeff Kinell, CEO of Bracket. “We’ve invested tremendously on improving outcomes in the area and we’re hopeful that this focused sub-committee will connect the right data, minds and initiatives to move AD trials forward.”

With plans to meet several times per year at relevant meetings such as American Academy of Neurology Annual Meeting and Alzheimer’s Association International Conference, the committee will share meeting notes and coordinate on common projects with Bracket’s SAB, while operating independently. The SAB is currently chaired by Dr. Charles Nemeroff, M.D., Ph.D. and Dr. Jeffrey A.Lieberman, M.D.

About Bracket
Bracket, with nine offices and more than 700 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.

Revolutionizing the Clinical Trial Supply Chain with Acquisition of CLINapps

WAYNE, PA — Bracket, a leading clinical trial technology and specialty services provider, today announced the strategic acquisition of CLINapps Inc., an international software development and consulting firm that offers a comprehensive supply chain management product suite, designed to meet the unique requirements of biopharmaceuticals management.

Effective today, CLINapps will combine its complimentary product offering with the Bracket eClinical suite to deliver a wider range of digital solutions across a trial. With synergies across their individual product offerings, Bracket and CLINapps maintain significant opportunities to revolutionize supply chain management.

“CLINapps’ strong technology fits squarely into Bracket’s goal of transforming the way pharmaceutical companies manage data and interact with sites, investigators and patients,” said Jeff Kinell, CEO of Bracket. “We are extremely excited to converge with CLINapps and work to improve how sponsor companies manage their clinical supply chain.”

CLINapps’ product portfolio will be tightly integrated into Bracket’s eClinical product suite, adding significantly to the Company’s existing Randomization and Trial Supply Management (RTSM) capabilities. SmartSupplies, CLINapps’ flagship enterprise clinical trial material management software solutions, will give Bracket the opportunity to manage end-to-end clinical inventory management for sponsors. Bracket’s new integrated solution will advance areas of demand planning (forecasting), inventory management, cold chain distribution and controls electronic batch records and overall quality control on the labeling, release, assignment and return of clinical trial materials.

“This acquisition marks an exciting opportunity for CLINapps and we are so pleased to have partnered with Bracket to help take our eClinical clinical supplies solutions to the next level,” said Tim Elliott, CEO at CLINapps. “Upon recognizing the many synergies that existed, the opportunity to combine our conceptual and innovative solutions was an obvious answer to advancing this life sciences space.”

Founded in 1999, CLINapps maintains offices in San Diego, California and Hyderabad, India and will continue to operate these locations, expanding Bracket’s presence in North America and Asia.

About CLINapps
Established in 1999 with international offices, CLINapps is a fast-growing software development and consulting firm, creating state-of-the-art systems for the pharmaceutical and biotechnology industries.

With a full time staff of highly skilled industry professionals, and a strong customer focus, CLINapps has a track record of providing high-quality end-to-end solutions for leading Biotechnology and Pharmaceutical companies. By leveraging our extensive domain knowledge and applying proven technologies, our mission-critical solutions give customers a distinct competitive advantage.

About Bracket
Bracket, with seven offices and more than 600 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.

Bracket Announces New eCOA Milestones on Industry-Leading Rater Station Platform

Wayne, PA – Bracket, a leading clinical trial technology and specialty services provider, announced today that 20,000 patients have been evaluated using the newest version of its industry-leading Rater Station eClinRO platform in clinical trials. Bracket’s eCOA solutions are used extensively by pharmaceutical and biotechnology companies to collect and manage Patient-Reported and Clinician-Reported Outcomes in clinical trials.

Bracket also announced a new release of Rater Station Web, a platform used by sponsors and clinicians worldwide to centrally support the management and conduct of clinical trials utilizing electronic Clinician-Reported Outcomes in global studies. Rater Station Web allows sponsors to report on site and outcome data from their programs using a centralized, configurable portal. Rater Station Web is also used by clinicians worldwide to conduct blinded clinical review and quality assurance on clinical outcome data. This includes confirmation on subjective outcome scoring, web-based review of audio and video of clinical trial visits, and independent Central Rating and Central Scoring.

“Bracket is working aggressively to bring together both our eCOA platform and our extensive experience utilizing quality assurance and predictive analytics to improve outcomes in research programs,” said Jeff Kinell, CEO at Bracket. “This release improves our ability to implement these programs worldwide, and gives sponsors and clinicians a better tool for clinical trials.”

In addition to the 20,000 patient milestone, Bracket also announced;

  • 75,000 subject visits have been captured using the Rater Station
  • 100 unique Clinician-Reported and Patient-Reported Outcomes have been developed and implemented in clinical trials

Bracket will be demonstrating Rater Station Web and presenting new findings related to their eCOA solutions at the CNS Summit in Boca Raton, FL, beginning on Thursday, October 27.

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.

Bracket Announces New Study for Assessment of Brain Insulin Resistance in Alzheimer’s Disease

WAYNE, PA  –  Bracket, a leading clinical trial technology and specialty services provider with expertise in Alzheimer’s Disease, announced today a new study partnership with researchers at Massachusetts General Hospital (MGH) on the ‘Assessment of Brain Insulin Resistance in Alzheimer’s Disease Using an Insulin Clamp’. The researchers will utilize its proprietary CDR System™ in the study, which is both a product of the Bracket eCOA™ product line and the industry standard for automated assessment of cognitive function in clinical trials.

The study will determine the effects of hyperinsulinemia on brain physiology, brain electrophysiological responses, and neurocognitive performance among subjects with and without Alzheimer’s Disease. Brain insulin resistance is emerging as a major mechanism of interest in Alzheimer’s Disease. While data from autopsy studies and animal research have shown that neurons are resistant to insulin in Alzheimer’s Disease, it has been difficult to directly demonstrate this in humans.

“Using advanced neuroimaging, electrophysiology, and cognitive testing methods from Bracket’s CDR System, we are comparing the effects of experimentally-induced high insulin levels on the brains of individuals with Alzheimer’s Disease and healthy older adults,” said Dr. Aaron Koenig, Assistant in Psychiatry, at Massachusetts General Hospital, Research Fellow in Epidemiology, Harvard School of Public Health & Assistant in Research (Psychiatry), Harvard Medical School. “This is an important study that could clearly establish the presence of an abnormal brain insulin response in Alzheimer’s Disease, and may provide useful tools for current and future treatment research in this very common disorder.”

Early-to-market with a flexible platform for eCOA and with specialties in Alzheimer’s Disease trial technology and services, Bracket’s CDR System provides clients with the most sensitive set of tests ever developed to assess improvements and impairments in cognitive function. The system assesses the major domains of cognitive function that are vulnerable to aging, fatigue, disease, pathology, trauma, diet and pharmaceuticals. To date, the system has been used in more than 1,200 trials across 50 indications.

“Establishing new targets for therapeutic interventions in Alzheimer’s Disease is essential. This study is an exciting opportunity to explore a new pathway, and we feel that the CDR System is particularly well-suited to help identify any potential signals,” said Professor Keith Wesnes, developer of the CDR System and a consultant to Bracket.

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.