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Bracket RTSM (Randomization and Trial Supply Management) represents a best-in-breed, scalable and configurable Clinical IRT solution for the life sciences industry. Through Bracket’s deep expertise in RTSM consultancy, coupled with our industry-leading Study Configuration Wizard™, we offer clients rapid and high quality results.

Why Bracket RTSM℠?

Bracket’s Randomization and Trial Supply Management (RTSM) represents a best-in-breed, scalable and configurable Clinical IRT solution for the life sciences industry. Bracket’s Randomization and Trial Supply Management (RTSM) platform provides quality optimization, consistency within clinical program and sponsor-specific needs, and timeline acceleration with a fully live and operational system in four weeks.

By leveraging Bracket’s deep experience and innovative Randomization and Trial Supply Management (RTSM) solution, we enable clients to implement standardized or complex system delivery requirements, well-suited to manage simple or highly innovative, large or small clinical trials.

Modalities

Bracket’s innovative RTSM solution allows for single build, multi-modalities deployment supporting traditional IVRS, IWRS and first-in-industry Interactive Mobile Response System (IMRS). Bracket’s refined solutions eliminate error and streamline results. By providing Bracket’s clients with best-in-class solutions and deep expertise, we lead the industry in RTSM.

Services

Bracket’s RTSM services focus on Library Consultancy and Development for client-specific library planning and implementation, Trial Supply Optimization for adequate and timely dosing of trial patients, and Project Management for support and guidance from project kickoff to implementation. End User Support ensures continuing and effective service and Bracket’s Biostatistical solutions are backed by our team’s expertise and industry-leading design skills.

RTSM Library Consultancy & Development

Through Bracket’s deep expertise in RTSM consultancy, coupled with our industry-leading Study Configuration Wizard™, we offer clients rapid and high quality deployments.

Bracket’s deep expertise in Randomization and Trial Supply Management RTSM consultancy, coupled with our industry-leading Study Configuration Wizard™ enable us to offer clients rapid and high quality deployments by implementing client-specific libraries meeting unique RTSM requirements.

Our advantages include:

  • Experienced team of Business System Analysts, focused on consulting on client and study-specific business requirements
  • Mature implementation framework enabled by Bracket’s Study Configuration Wizard™ to develop and implement Libraries for continued system implementation
  • Optimized processes to streamline the testing and ultimate deployment of Library artifacts, reducing client-specific testing requirements

Trial Supply Optimization

Bracket offers a fully-integrated and industry leading framework for complex trial supply management.

Bracket’s years of RTSM experience, coupled with ongoing innovation of supply chain management, offers clients a best-in-class solution to optimize global trial supplies, ensuring their patients around the world are dosed adequately and on time. Providing the first and only true mobile application supporting RTSM, Bracket keeps the end user in mind and the patient’s safety at heart by providing barcode-enabled trial supply monitoring checks and drug expiry monitoring. Bracket provides self-service, web-based, drug release and emergency drug ordering, enabling clients to meet unique trial demand. Our superior process includes:

Automated resupply methodologies (threshold, predictive, buffer, just-in-time) and inventory pooling across protocols (at depot or site levels), reducing trial supply overage

  • Kit and/or lot number (quantity based) inventory management to support open label or concomitant therapy management
  • Barcode scanning for drug dispensation confirmation (mobile app)
  • Temperature excursion / quarantine management for effective cold chain supply management and trial supply administration
  • Complete Investigational Product Returns (IPR) solutions to meet client internal regulatory requirements

Project Management

Bracket operates in a team structure designed to optimize our ability to service our clients and to provide senior leadership from both a technical and project management perspective.

Bracket operates in a team structure designed to optimize our ability to service our clients.  We provide senior leadership from both a technical and project management perspective. Our goal is to continue building a highly-scalable resource model while leveraging each team’s expertise, allowing us to better serve our clients. our cross-functional team offers support from the time of project kickoff through solution implementation. Ongoing support includes:

  • Experienced project managers and support staff to execute on a comprehensive project lifecycle (PLC)
  • Solution-oriented PLC, integrating a proven project management methodology overseeing software development lifecycle (SDLC) controls
  • Integrated validation framework, facilitated by Bracket’s Total Quality Management organization, to manage SDLC gates throughout the entire project lifecycle

End User Support

Bracket provides direct support across our entire portfolio of solutions, providing a seamless end user experience unique to the technology and service implemented in support of our clients’ clinical needs.

Bracket provides direct support across our entire portfolio of solutions, providing a seamless end user experience unique to the technology and service implemented in support of our clients’ clinical needs.

  • 24x7x365 global end user support to meet the requirements of global clinical trials
  • Dedicated and trained Bracket personnel, supporting unique needs of each clinical solution and study-specific implementation
  • Multilingual capabilities to support global end user requirements
  • Regulatory-trained support personnel to ensure 21 CFR Part 11, HIPAA, and Safe Harbor Compliance throughout the support process

Biostatistical Expertise

Bracket offers randomization and kit lists generation and management, leveraging over 25 years of industry leading biostatistical design. Our statistical department utilizes the latest SAS software and relies on established and controlled processes to maintain blind.

Statistical Services

Bracket’s statistical services and advantages include:

Statistically-led randomization solutions (central, stratified, dynamic, adaptive)

Configurable to meet the needs of simple and highly innovative trial designs

Error-proof titration lookups and calculations

Seamless cohort & dose escalation management

Biostatistical Methodologies

Bracket can design and implement, within its RTSM solution, a variety of randomization methodologies to meet protocol design constructs across every phase of clinical research. Bracket developed Precision Block Design for sponsors who want or need to utilize block pattern distribution in their randomization lists when using Bracket RTSM. Bracket’s methodologies include:

Permuted Block Design

Dynamic Randomization

Adaptive Trial Design

Cohort Trial Design


SMS Patient Reminders

Bracket’s newest addition to the RTSM platform is SMS Patient Reminders.

This core component of Bracket’s RTSM 4.0 platform sends mobile patient reminders, delivered via SMS text messaging, directly to the patient’s mobile phone once opted in to the service.

All messages and patient data are encrypted and stored safely. The service is now available globally, and the reminders can be tailored to specific dosing regimens and communications types on a study-by-study basis.

Learn More >

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To inquire about Bracket RTSM and Bracket’s other services, please contact us today.

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