Cell and Gene Therapy Services

Vineti’s PTM® platform is the proven solution that delivers and drives the personalized therapy supply chain.  PTM® is fully backed every step of the way by our industry-leading Customer Success team.

Establishing and running an end-to-end personalized therapy supply chain is a complex undertaking. Once you’ve made the decision to leverage the fully integrated and validated cloud-based PTM® platform, Vineti’s Customer Success team will work with you to set strategies that define your requirements, manage your configuration and implementation, and provide full support along the way, including once your instance of Vineti goes live.

Vineti’s Customer Success team is composed of experienced implementers with the most complete knowledge base in the industry. From initial requirements definition and workflow planning through ongoing support, training, and upgrades, we provide comprehensive, continuous, responsive service to accelerate and streamline the patient journey.

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“Our experienced team focuses on keeping things as simple as possible for our customers, with expert implementation services and excellent technology. That way, our customers can focus on what matters most to them — their therapy, their science, and the patients they serve.”

Joe DePinto, Chief Commercial Office at Vineti

Optimized workflow

Vineti’s team of experts works as a strategic and functional partner with your own team to simplify end-to-end personalized therapy workflows. Our goal with every engagement is to make the entire process more efficient, while meticulously maintaining Chain of Custody and Chain of Identity and implementing a solution to optimize your cell and gene therapy operations.

Supply chain process review

The success of your therapeutic workflow depends on how well it is mapped prior to platform configuration. With our expertise in orchestrating personalized therapeutics, the Vineti team performs a thorough process and workflow review. We collaborate on optimizing the processes and workflows that support your therapy, whether your treatment is in early-stage clinical trials, late-stage pivotal trials, or scaling commercially.

Requirements and validation

The Vineti team collaborates and advises during the requirements-gathering phase. Agreeing upon the User Requirements Specification (URS) is a key first step. We advise your team on the best validation deliverables to meet all regulatory requirements; this is a critical outcome that drives many decisions throughout the implementation process.

Implementation

To support the therapeutic and business targets of each customer, the Vineti team configures, integrates, and launches the PTM® platform to your therapy’s specifications, The Vineti team works to align the flexible cloud-based PTM® platform to quickly and thoroughly meet your workflow and product process needs.

Integration

Vineti’s cloud-enabled solution offers proven connectivity with other systems and technologies in the therapeutic ecosystem. Our team works with you to create connections with other data and processing solutions such as EBR, ERP, IWRS, MES, CRM, and logistics systems.

Ongoing configuration and updates figuration

Many advanced therapy workflows require updates down the road as product processes and industry best practices evolve. Vineti’s enterprise platform approach means that updates are simpler and quicker, and industry best practices are baked into the platform and always available to all customers.

Compliance and security

The Vineti team works with each customer’s IT and Quality organizations to generate a robust risk-based validation and testing package and automation to ensure compliance with complex regulations and standards.

Critical standards

With the PTM® platform, biopharmaceutical companies receive a compliant solution with every implementation. Running on Amazon Web Services (AWS), PTM® solutions are compliant with critical standards for cell and gene therapies, including: HIPAA, GAMP-5, GDPR, GMP, NIST, Title 21 CFR Part 11, EUDRALEX Annex 11, etc.

Learn more about Vineti’s commitment to security and compliance

Product specific documentation

Vineti’s team puts all product specific documentation into place prior to implementation. This documentation ensures that all parties are in agreement on the details of what will be delivered, how it will be tested, and what will be flexible for scale.

Validation and testing

Vineti’s team makes certain that each customer’s PTM® configuration is fully validated to launch successfully and to maintain compliance in an ever-changing ecosystem.

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Training

The success of maintaining a smooth and efficient patient journey depends on the expertise of those responsible for using, maintaining, and administering the orchestration solution. Vineti’s services always include a supportive training plan.

Custom training materials

When biopharmaceutical customers commit to a PTM® solution, they receive in-depth, hands-on, module-by-module instruction. Vineti training accompanies each implementation and is tailored to each therapy’s specific workflow. Training always includes:

  • Custom training manuals
  • Sandbox walk-throughs
  • “Training the Trainer” sessions

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Technical support

Vineti’s dedicated software support team members are available to our customers around the clock, every day, worldwide. We provide customized technical and operational cell and gene therapy software customer support based on Service Level Agreements to ensure that each implementation continuously meets the needs of each personalized therapy.

Always on call

Our cloud-enabled PTM® solution includes automatic continuous monitoring. With global representation, Vineti’s software support team is always on call to address any immediate concerns, including disaster recovery protocols.

Long-term planning

Vineti’s Account Managers are available to help navigate the long-term product lifecycle and collaborate on additional requirements as each therapy scales.

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Platform updates

One of the primary benefits of our cloud-based solution is dynamic and seamless lifecycle management.

Continuous expansion and updates

Our cloud-enabled PTM® solution is continuously maintained and seamlessly updated, allowing efficient global scaling. With each scheduled software release, customers gain access to updated features and functionality. These offerings are added regularly to support emerging customer needs and market segments for both clinical and commercial therapies.

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