Cellular therapy represents a rapidly advancing and promising approach for treating blood cancers, solid tumors, and even non-malignant conditions such as liver cirrhosis and autoimmune diseases.
At CellServe, we aim to transform the current healthcare model by expanding access to advanced, tertiary-level care—making cutting-edge therapies more accessible and bringing them closer to the patients who need them. We support the development of your cell therapy and clinical research programs through expert training, hands-on coaching, and guidance in clinical operations and quality services.
and effectively. Our team conducts a comprehensive evaluation, culminating in a scored Gap Assessment Report (GAR). This report either confirms institutional readiness or outlines the specific actions required to achieve it.
We provide in-depth operational and quality-focused training and support across all program components, including clinical care, apheresis collection, bone marrow harvest, and cell processing. This phase also includes expert guidance on the development and implementation of Standard Operating Procedures (SOPs) and Clinical Practice Guidelines (CPGs). Upon completion, we deliver a Readiness Report (RR) that identifies existing gaps and recommends targeted improvements prior to progressing to the implementation stage.
This phase marks the initiation of the cellular therapy program. It begins with a simulated “dry run” procedure without a patient, designed to assess operational readiness. The outcomes are summarized in a Debriefing Report (DR), which is reviewed collaboratively with your team. Based on this review, a joint decision is made regarding readiness to treat the first patient. Our team provides on-site, hands-on support throughout the process to ensure optimal coordination of personnel, logistics, and infrastructure. Together, we will evaluate the need for continued support beyond the first patient treatment.
We offer tailored, ongoing support services to meet the evolving needs of your cellular therapy program. While this phase is primarily conducted remotely, in-person consultations are available as needed or upon request to address complex challenges or program milestones.
CellServe collaborates with organizations developing innovative cellular therapy products that align with our core mission: expanding access.We help bring promising, cutting-edge therapies closer to patients by establishing and supporting the clinical research infrastructure required to evaluate these therapies through clinical trials.
Our focus is on cellular therapies that offer advantages such as simplified manufacturing and lower cost which can make these treatments accessible beyond the United States.We equip your team with the tools and expertise needed to finalize trial design and build a compliant clinical research infrastructure that meets the highest quality and regulatory standards.
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