For Personalized Therapies

A complex journey

From the patient, to the lab, to the patient

Vineti’s solution connects those responsible for bringing a cell or gene therapy to the patient. Whether the solution needs to manage the workflow for five patients in a Phase 1 clinical trial or fifty thousand patients in a global commercial product, the therapy requires significant people and process management. Vineti makes this possible.

Clinical and Commercial Phases

  • Early Clinical

    Traditional one-to-many therapies did not require significant software in Phase 1 trials; Excel could manage most data and coordination needs. In personalized medicine, however, the therapy becomes risky and overwhelming to manage with 10 or more patients. Enter Vineti’s Ready to Use solution, which includes Chain of Identity (COI), Chain of Custody (COC), plus clinical site, manufacturing, and logistics management. 

    Learn More

    Early Clinical
  • Late Clinical

    As therapies enter late stage clinical trials — and commercialization becomes foreseeable — regulators begin requiring data to support claims of consistently reliable delivery. Internal organizational complexities arise to support growing scale. Vineti’s solution is flexible to meet these requirements and increasing demands.

    Learn More

    Late Clinical
  • Commercial

    The only third-party software supporting commercially available therapies, Vineti’s robust toolset manages multi-region and multi-language clinical support, shipping, manufacturing, and compliance. For pharmaceutical companies seeking rapid commercial expansion, the Vineti platform makes this ambition feasible.

    Learn More

    Commercial

Regional to Global

Vineti is flexible for global operations, supporting therapies manufactured and delivered in North America (United States and Canada), Europe, and Asia. Whether your therapy remains within one country or spans multiple continents, Vineti is configurable to support the workflow. With a focus on specific requirements for regional compliance, Vineti’s platform also functions in many Latin- and character-based languages.

Autologous, allogeneic, and personalized cancer vaccines

Because Vineti’s solution is flexible to meet each therapy’s workflow, it is able to support autologous, allogeneic, and personal cancer vaccine therapies. Working together with the biopharma team, the solution is configured to support the right workflow required for each particular protocol. If a customer has multiple therapies and different modalities, the system can support the unique configuration required for each within one account.

Key roles in the therapeutic workflow

Each therapy requires careful handling and oversight from dozens of people across a complex, multi-party, interdependent supply chain. 

Clinical Operations / Case Managers

Key coordinator collecting and sharing pertinent information throughout the patient journey. Needs up-to-date process information to ensure smooth therapy delivery.

Supply Chain Logistics

Oversees the viability and safety of the patient's personalized material throughout the process, from collection and manufacturing completion through delivery and infusion.

Collection Staff

Nurses and pharmacists collecting cells and genes per SOP. Once collected, must package, label, and ship according to specification.

Patient

Individual with hope of receiving new, breakthrough treatment to alter the course of their lives.

Transport Logistics

Orchestrates the pick up, shipping, and delivery of the patient's material between clinical site(s) and manufacturing site(s).

Manufacturing

Oversees consistent, reliable manufacturing for each therapy. Manages capacity for weekly manufacturing slots. Potentially manages multiple manufacturing sites, providing quickest potential location for processing.

Transport Logistics

Oversees consistent, reliable manufacturing for each therapy. Manages capacity for weekly manufacturing slots. Potentially manages multiple manufacturing sites, providing quickest potential location for processing.

P.I./H.C.P.

Responsible for patient wellness and decision for condition-therapy fit. Integral to patient registration, ordering, and long-term monitoring.