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.
“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!