Cell Therapy Clinical Trials
Software to support your cell therapy and gene therapy clinical studies
More than 1,000 cell and gene therapy clinical trials are underway worldwide, and each one comes down to individual patients who require clinical trial operations as sophisticated as the emerging science itself. It can be daunting to get any trial opened and initiated, enroll patients, and keep everything moving on time to reach scientific and regulatory milestones. In cell therapy and gene therapy trials, additional obstacles such as patient-specific supply chains and large volumes of Chemistry, Manufacturing, and Controls (CMC) data can sometimes make the complexity seem overwhelming.
Vineti’s PTM® platform, proven with both clinical-phase and commercial cell and gene therapies, provides the essential support and simplification that advanced therapy clinical trials need. PTM Essentials™, a version of the Vineti platform configured specifically for advanced therapy clinical trials, can get autologous clinical studies moving quickly, simply, and cost-effectively.
Challenges and solutions
Advanced therapy clinical trials represent some of the most complex operational endeavors in the history of medical inquiry. Cell and gene therapy product and patient journeys require sophisticated orchestration to succeed, but they face a variety of obstacles.
Clinical trial teams need advanced tools and systems to keep their phases in forward motion and provide high-quality patient care that builds trust and confidence.
Vineti’s Personalized Therapy Management (PTM)® platform has already orchestrated thousands of patient and product journeys worldwide for clinical trials and commercialization.
PTM® allows you to smoothly manage supply chain complexity and keep your clinical trial program on track.
Distributed, complex supply chains built around patients and donors can be extremely difficult to view, track, and manage.
Solution: A proven, configurable platform that gets your manufacturing up and running sooner and keeps your end-to-end times on track.
Quality requirements are rigorous, including those related to Chain of Custody and Chain of Identity.
Solution: Flexible, compliant cloud-based label printing on any hardware.
Manufacturing batches are small — often as small as one per patient.
Solution: “Smart scheduling” to optimize manufacturing slots and shipping from clinical sites, labs, manufacturing facilities, and storage centers worldwide, allowing a higher volume of order fulfillment
A novel manufacturing paradigm means that the cell therapy production process extends beyond the traditional factory and into hospitals and healthcare settings not covered by Good Manufacturing Practices (GMP) guidance.
Solution: Industry-leading digital Chain of Identity and Chain of Custody, with digital workflows that walk stakeholders through GMP processes step by step and capture required data and signatures
Traceability is essential end to end, yet difficult to maintain across a distributed ecosystem.
Solution: End-to-end traceability and product tracking
Manufacturing capacity is often limited and must be orchestrated in real-time to take advantage of every available slot.
Solution: Best-in-class, user-friendly capacity management — set up your manufacturing capacity and allow your stakeholders to book slots, arrange shipments, and make the process work for them and for you.
The supply chain can be highly variable and unpredictable, with non-stop volatility complicating everything from raw material collection, to shipping, to manufacturing suite usage.
Solution: Automated dashboards give visibility into the status of entire product lines or individual product journeys. Best-in-class change management tools, steeped in real-world experience. Need to reroute a batch to a different facility, print a revised label, or reschedule a shipment? With PTM®, it’s no problem.
Manufacturing processes can be complex and require a high degree of precision and compliance.
Solution: Automated regulatory compliance. Patient- and collection-related documents, such as those related to starting material, that are readily available any time via a cloud-based digital system.
Data management is of vital importance: large amounts of data must be documented, collected, and reported for each batch. Chemistry, Manufacturing, and Controls (CMC) data takes on greatly increased importance in cell and gene therapy approvals, and gaps or errors have the potential to trigger extensive regulatory delays.
Solution: Proven data management, ranging from per-patient data to process-wide analytics and enabling a robust, auditable CMC package.
Fast scale-ups are expected: beyond the earliest stages of a clinical trial, manufacturing experts are asked to quickly scale up production processes that may have been developed for just a few patients.
Solution: Built-in standards and best practices help streamline the transition to greater scale, and configurability that lets you create a version of PTM® that supports your product.
Manufacturing costs can be high, and every additional complexity makes these costs harder to control. Manufacturing teams are asked to bring breakthrough science to life while keeping a rigorous eye on the bottom line.
Solution: A more cost-effective way to manage the distributed resources so often found in cell and gene therapies, where manufacturing can be done in-house, via satellite or contract facilities, or through a mix of all these options.
“My manufacturing extends out in many directions, and I need one place where I can see it all and manage it all — what’s coming in, what’s in process, what’s final product, and what’s shipping out for infusion. Manufacturing for cell therapies is multi-dimensional, and it never stops moving. I need a quality-centered system that lets me handle everything, from a master view of every batch down to a single product for one patient.”Manufacturing lead, late-stage autologous cell therapy company
Mastering your cell and gene therapy clinical trials with PTM®
If you focus on standing up and managing clinical trials, PTM® provides mission-critical support with:
- The tools and systems you need to keep patients moving through your trial smoothly, including automated COI and COC.
- Digital stakeholder management, coordination, and access control.
If you help hospitals and clinics prepare to participate in trials, PTM® helps by delivering:
- Administrative tools to set up users, manage stakeholders, and control access to your clinical trial systems.
- Digital pre-manufacturing documentation.
- Automated report generation and audit documents/trails.
- Digital records that are easy to access and cross-reference from anywhere.
If you operate advanced therapy clinical trials on behalf of biopharmaceutical developers, PTM® puts automation within reach by providing:
- Best-in-class digital systems for managing personalized patient product supply chains.
- Industry-leading compliance tools, ensuring conformance with a wide variety of regional regulations while protecting patient privacy and data security and integrity.
- Automated dashboards and record-keeping to provide critical information, including real-time product status updates, trial-wide analytics, and audit-related reports.
Clinical-phase solution, Vineti scales with you
Get a glimpse! PTM Essentials™ is a breakthrough supply chain management innovation for advanced cell and gene therapy clinical trials. The clinical-phase solution, PTM Essentials™, delivers advanced therapy clinical studies quickly, safely, and simply with a turn-key supply chain management solution. Get in touch with us today to learn more!
Explore the PTM® solution for clinical trials
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Whether you are handling manufacturing for early clinical trials or for commercial scale, Vineti is here to help.