Accelerate Research & Clinical Development

Delivering the global R&D services that are driving cell and gene therapy innovations

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The united power of trials, labs, and data combined with unparalleled experience with cell and gene therapies is accelerating greater insight and faster cell and gene therapy development. By integrating these critical services within a single global organization, Precision amplifies proven scientific approaches, streamlines complex processes and minimizes risk.

50+ research and clinical development projects supported in the last two years
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Cell and Gene Therapy Clinical Trial Development

New treatment modalities—such as cell and gene therapies—require novel approaches to demonstrating safety and efficacy. From pre-clinical through registration studies, our experts are leaders in the advancement of cell and gene therapy development, leveraging the research interests of the sites to build clinical enthusiasm, supporting the logistical complexities of these trials, and addressing complex safety issues.

Our teams bring broad-reaching experience in both cell and gene therapies, spanning therapeutic areas including oncology, CNS, autoimmune disease, cardiovascular disease and hemophilia. With our experience in rare disease, solid and liquid tumors, our teams meet logistical and regulatory challenges with bold solutions that accelerate your development cell and gene therapy development pathway.

Cell Therapy –Autologous and Allogeneic

  • CAR-T cells
  • Stem cells
  • Tumor-infiltrating lymphocytes
  • TCR Therapy
  • Cell Therapy – Other

Gene Therapy

  • Multiple AAV serotypes
  • Lentivirus
  • Exosomes

Cell and gene therapy clinical trials require distinct skill sets. Our multidisciplinary teams have these skills, with global cell and gene therapy expertise across clinical trial operations, regulatory, pharmacovigilance, and medical monitoring. These experts anticipate obstacles and provide strategic guidance—ensuring site-to-site consistency in crucial processes from raw material collection to bedside therapeutic administration.

  • Clinical development strategy and planning
    • Study design and protocol development
    • Manufacturing logistics
    • Toxicity Management Guidelines
  • Cell and gene therapy experience navigating CBER, CDER, and ex-US Regulators, as well as site-level IBC requirements for cell and gene therapy
  • Experienced Investigators with documented experience in cell and gene therapy
    • Investigational Product Receipt and Processing Plan
    • Logistical oversight of supply chain management
    • Labelling requirements
  • Robust data-driven monitoring strategy
  • Rapid AE identification and management
    • Ongoing patient safety and data trend analysis
  • Data Safety Monitoring Boards
  • Data collection strategy
    • eCRF development
    • Data visualizations
    • Scientific and medical remote data review
  • Biometrics/biostatistics and oversight
  • CDISC programming and documentation
Logistics for both allogeneic and autologous cell therapy, as well as gene therapy studies require a high level of coordination, organization and oversight. We are meticulous, precisely orchestrating sample collection based on protocol requirements to mitigate risk and ensure trial success.

  • Customized kit manufacturing
  • Site support and lab manuals
  • Real-time sample processing (assays and PBMCs)
  • Virtual Sample Inventory Management
  • Global biobanking (tissue and cells)
  • Quality standards and certifications (CAP, ISO, GxP)
  • Transport management and 24/7 tracking and reporting
Gloved hand pointing at cell and gene therapy development

Specialty Lab Services for Gene and Cell Therapy Clinical Research

Cell and gene therapy research requires specialized expertise to support successful translation from the bench to the clinic. We deliver, with a broad array of both established and Precision-engineered platforms targeted specifically to the needs of cell or gene therapy development, and thought leaders who are helping shape the therapeutic and regulatory landscape.

Laboratory assays for evaluating the efficacy and safety of cell therapies—which are essentially living drugs—may require innovative approaches. We support cell therapy development, from providing insight into cell biology and pharmacodynamics to generating quantitative data that can be used to optimize the profile and manufacturing of these complex therapeutics.

  • Molecular characterization of CAR T-cells using the nCounter® CAR-T Characterization Panel
  • Cell expansion, distribution and persistence assays using ddPCR or flow cytometry
  • Cytokine, chemokine, and pro-inflammatory assays
  • Sequencing for aberrant CRISPR events
  • Measurement of minimal residual disease using flow cytometry or NGS
  • Liquid biopsy using ApoStreamTM for CTC and rare cell capture and enrichment
  • IHC and multiplex IF for immunophenotyping and tumor profiling
  • Central laboratory testing services for global clinical trials
  • Epigenetic markers for immune cell lineages
Gene therapy holds great promise, but this field of research is still in its nascent stages and the optimal methods for unlocking its full clinical potential are still being defined. We support gene therapy development, from exploratory assays for preclinical development to companion diagnostics.

  • NAb and TAb assays (exploratory to CLIA, CE Mark or CDx)
  • Immunogenicity testing e.g. ELISpot and Fluorospot
  • Viral capsid and transgene expression assays
  • Distribution and persistence assays
  • Central laboratory testing services for global clinical trials
Image of genetic sequencing

Companion Diagnostic Services for Cell and Gene Therapies

The success of cell and gene therapies ultimately relies on accurate identification of appropriate candidates for treatment. These precision medicine products often require a Companion Diagnostic (CDx)—and that requires specialized clinical development, biomarker assays, regulatory strategy and commercialization capabilities.

To optimize assay efficacy, we dive deep to understand and address critical pivot points for the proposed CDx, ranging from access optimization to kit compatibility.

  • TAb and NAb companion diagnostic development
  • Cell-based, ELISpot, and immunoassay capabilities
  • Complete analytical studies under full design control
  • Cell bank development and maintenance
  • Extensive experience with multiple AAV serotypes
  • Regulatory strategies for LDTs, IVDs, and CDx
  • QMS development
  • FDA pre-submissions
  • IDE and SRD submissions
  • 510(k), de novo, and PMA submissions
  • Access, reimbursement, and channel analysis and strategy
Woman with headset reviewing cell and gene therapy logistics

Biomarker and Translational Intelligence

Biomarkers play a critical role in cell and gene therapy programs, identifying risk factors for adverse events and measuring the durability of therapeutic mechanisms. Because of the complexity involved with specialty labs running complex assays globally, we’ve developed a proprietary platform to provide timely visibility into sample availability and quality, data availability and quality, and critical on-study measurements.

Systems and processes used to track samples and monitor patient status are dispersed across CROs, labs, and sponsors. Precision for Medicine’s QuartzBio team, has developed proprietary technology-enabled capabilities, to centralize and harmonize this non-standard and silo’d data from across the ecosystem.

  • Integrated visibility across sites, central, and third party special labs
  • Site-level sample QC metrics and availability
  • Results-data availability across multiple assay modalities
  • Assay- and batch-specific data quality on-study
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