PTM Essentials cell therapy clinical trial accelerator software

A  new breakthrough clinical trial accelerator for medicine’s most complex studies

PTM Essentials is Vineti’s purpose-built solution that helps cell and gene therapy clinical trials start up quickly and run simply. This purpose-built system has the flexibility to meet the shifting needs of patients and healthcare providers – all without disrupting operations or compromising quality and safety. This is a modular system that grows with you.

When developing a supply chain strategy for cell therapy, gene therapy, or cancer vaccine trials, advanced therapy innovators face several major hurdles:

  • Developing and testing a technology solution to manage complex workflows takes time
  • New software systems can be challenging for members of small, early-stage teams to implement and operate
  • Compliance, quality, and security standards can be complex and time-consuming to address
  • Critical Chemistry, Manufacturing, and Controls (CMC) regulatory guidances must be followed to collect and report large volumes of required data and avert costly regulatory delays
  • A fully-featured commercialization solution may not be in your program’s R&D budget

PTM Essentials™ is a turn-key digital solution for autologous advanced therapy clinical trial supply chains. This industry-leading, off-the-shelf accelerator enables advanced therapy R&D to run more quickly, with best-in-class supply chain operations, data management, quality, and security built in from the start. PTM Essentials™ scales with your trial program and seamlessly transitions into a full commercial-grade solution when the time is right.

Scientist looking through microscope

A turn-key supply chain solution for autologous therapies

  • Built-in best practices get your supply chain operations up and running quickly
  • Key configuration features let you choose options that are right for your patient management, workflow needs, and brand
  •  Based on a wide range of clinical-phase experience across a wide variety of indications, from oncology to rare disorders
  • Core solution is already deployed in hundreds of clinical sites in 20 countries
  • Includes security, data privacy and compliance with critical industry regulations
  • Best-in-class data management avoids the risks and data losses common in paper-based systems. Teams can stay on track to hit key trial and filing milestones, including mission-critical CMC data packages
  • Core solution is pre-validated — every deployment includes a validation starter kit that gets customers live in weeks

Why PTM Essentials?

PTM Essentials is the turnkey cell and gene therapy clinical trial accelerator that provides critical infrastructure for personalized therapy clinical trials.

  1. Fast implementation

    This modular system gets your program up to speed quickly, with built-in best practices and a validation starter kit.

  2. A quicker path to approval

    By streamlining the supply chain, collecting and harmonizing data, and providing best-in-class reporting, PTM Essentials™ accelerates the pace of research and enables cell and gene therapy programs to meet stringent CMC requirements and hit trial milestones on time and on budget.

  3. Built-in standards

    Standardized requirements templates and a configurable platform provide proven, experience-based best practices for the workflows the sector relies on most.

  4. Compliance

    This proven and validated solution meets rigorous compliance requirements and regulations right out of the box, including GAMP5, cGMP, 21 CFR Part 11, EUDRALEX Annex 11, HIPAA, GDPR, NIST, ISBT-128, and SEC.

  5. Affordability

    PTM Essentials™ is considerably less expensive than custom-built solutions. It offers the best of PTM®’s clinical trial capabilities at a price point that works for early-phase projects.

  6. Flexibility

    The modular platform grows with you as you scale to commercialization or expand into new geographic and therapeutic areas. PTM Essentials™ adapts to meet the shifting needs of patients and healthcare providers without disrupting operations or compromising quality or safety.

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PTM Essentials features

PTM Essentials replaces outdated, disparate, bespoke clinical trial systems with a single purpose-built foundation.  The platform comes pre-loaded with a “best practices” configuration for clinical trial needs. PTM Essentials offers functionality across the clinical trial journey.

  1. Ordering and Patient/Trial Subject Management

    A branded user experience for ordering clinical-phase therapies, with a system that sites of care already know and trust that ensures patient data and privacy rights are protected

  2. Collection and Infusion Management and Tracking

    Automated, paperless, validated system to manage processes, ensure Chain of Identity and Chain of Custody, collect accurate data, and maintain control of patient/donor material and product

  3. Logistics Management

    Automated courier logistics management configured for your clinical trial workflows

  4. Manufacturing Support

    Manage your manufacturing capacity, and enable your clinical site partners to schedule collections that sync with your shop floor

  5. Flexible Labeling

    All solutions are supported — pre-print and ship, or print to any printer, including hospital printers

  6. Manufacturing Scheduling

    Manage scheduling in real-time for time-critical procedures based on resource availability

  7. Tracking and Analytics

    Real-time order status tracking and aggregate self-service supply chain analytics, with data and reporting that enable simpler, faster inspections and filings

  8. Quality Assurance

    Permanent and transparent association of a therapy to the complete record of all activities

How our cell and gene therapy trial accelerator system works

PTM Essentials™ simplifies the advanced therapy clinical-phase supply chain.

Who:

  • Healthcare providers
  • Biopharma case managers
  • Supply chain managers

What:

  • Schedule orders based on manufacturing availability and therapy-specific timelines
  • Set manufacturing capacity

Why:

  • Streamline the scheduling process
  • Assure incoming volume matches available capacity
Three doctors reviewing information

Who:

  • Supply chain managers

What:

  • Manage courier shipments
  • Configure each delivery phase
  • Record Chain of Condition and Proof of Delivery

Why:

  • Eliminate manual shipment processes
  • Support complex routing needs
  • Attain full Chain of Custody traceability
Three doctors reviewing information

Who:

  • Healthcare providers
  • Apheresis collection staff
  • Cell therapy lab staff
  • Manufacturing staff

What:

  • Print to cloud and locally connected label printers

Why:

  • Leverage existing printing hardware
  • Maintain accurate delivery to ensure patient safety
Three doctors reviewing information

Who:

  • Biopharma staff

What:

  • Obtain real-time updates from all participants in the value chain

Why:

  • Address events in real time
  • Provide visibility and rapid data discovery
Three doctors reviewing information

Who:

  • Healthcare providers
  • Biopharma case managers

What:

  • Order commercial and clinical therapies inside the clinic on a branded experience
  • Initiate Chain of Identity
  • Manage scheduling

Why:

  • Provide the industry’s most user-friendly clinic experience
  • Optimize the ordering process
  • Make use of flexible, configurable workflows
  • Build trust for the brand among healthcare providers
Three doctors reviewing information

Who:

  • Apheresis collection staff
  • Cell therapy lab staff

What:

  • Manage paperless cell collection and final product processing at clinical sites

Why:

  • Provide staff with industry-leading usability
  • Maintain regulatory compliance
  • Improve accuracy and control of data
Three doctors reviewing information

Who:

  • Manufacturing staff

What:

  • Trace CMO, in-house, depot and satellite manufacturing
  • Track care site COC, match to COI, capture collection and infusion data
  • Support material receipt, storage, disposition, and shipping
  • Integrate to ERP/MES

Why:

  • Achieve transparency and control of product
  • Ensure regulatory compliance
Three doctors reviewing information

Who:

  • Biopharma staff
  • Healthcare professionals

What:

  • Associate therapy to complete end-to-end activities
  • Access audit reports while strictly protecting patient privacy and ePHI

Why:

  • Meet regulatory requirements for compliance and accountability
  • Ensure critical patient safety for accurate therapy delivery
Three doctors reviewing information

Demo video

See PTM®’s personalized supply management solution in action in this short video.

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Whether you are managing a handful of personalized patient-centric supply chains, or thousands, Vineti has the orchestration platform to get the job done.

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