Empowering Tomorrows Advances Today: Leading Cell & Gene Therapy Solutions
Accelerating Innovation Through Cell and Gene Therapy Solutions
Cell and gene therapy (CGT) represents a cutting-edge frontier in medicine, offering the potential to treat or even cure diseases at their most fundamental level – by modifying cells or genes within the body.
At Allucent, a specialized cell and gene therapy CRO, our dedicated team of CGT experts collaborates with small and mid-size biopharma companies to drive innovation in gene and cell therapy. We bring experience in all modalities, including autologous and allogeneic studies, dendritic cells, stem cells, and gene therapy, helping you realize the potential of these life-changing therapies.
Your Challenges in Cell and Gene Therapy Clinical Trials
Patient Recruitment
Enrolling patients into cell and gene therapy clinical trials is difficult due to a limited and geographically dispersed patient population, lack of awareness and diagnosis, rigorous eligibility criteria, complex logistics for treatment administration, and the high emotional burden on patients and their families.
Manufacturing & Logistics
Cell and gene therapy clinical trials face challenges in manufacturing, logistics, and supply chain management due to strict GMP standards, ultra-low temperature storage, precise coordination, and regulatory compliance.
Site Experience
Cell and gene therapy research challenges clinical sites with the need for specialized facilities, stringent regulatory compliance, complex logistics for sensitive materials, intensive staff training, and coordination for patient-specific treatments, demanding significant resources and operational expertise.
Regulatory Hurdles
Regulations for cell and gene therapy clinical trials are more complex compared to other therapies due to novel mechanisms, novel endpoints, manufacturing standards, personalized treatment protocols, the need for long-term safety data, and ever-evolving guidelines, as well as reimbursement and market access challenges.
At Allucent, a specialized cell and gene therapy CRO, we understand your challenges and act as your strategic partner to gain a competitive edge in the rapidly evolving field of cell and gene therapy, accelerating time to market and maximizing therapeutic impact.
With executive-level oversight, our dedicated team of cell and gene therapy experts provide extensive regulatory, operational, and consulting solutions, cutting-edge innovation, and a network of preferred partners, who are well-equipped to support the successful development and delivery of ground-breaking gene and cell therapies.
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Dedicated Cross-functional Team
Allucent has a dedicated team of cross-functional experts and cell and gene therapy consultants focused on optimizing strategy, study design, and delivery, who have successfully managed cell and gene therapy clinical trials in the past. This expertise helps ensure that your gene and cell therapy clinical trials are designed and executed effectively, with an understanding of potential pitfalls and best practices specific to cell and gene therapies.
Regulatory Strategy & Support
We have extensive knowledge of regulatory agencies and their specific biologics guidelines including CMC development and manufacturing strategies for cell and gene therapies. Our ongoing, extensive interactions with regulatory groups provide us with the opportunity to maintain an awareness of current FDA and EMA regulations, expedited pathways, guidelines, and positions regarding cell and gene therapy development programs. These interactions include the FDA’s division of the Center for Biologics Evaluation and Research (CBER), CGT branches of the Office of Therapeutic Products, Canada’s HPFB, and the successful navigation of the EU CTR.
Study Design
Allucent’s regulatory, biostatistical, modeling, and clinical pharmacology experts have expertise in designing and implementing complex and adaptive trial designs tailored to cell and gene therapy clinical trials that allow for modifications based on interim data without compromising the integrity of the trial, including seamless phI/II designs, basket trials, and master protocols.
Patient Recruitment & Retention
Allucents dedicated Patient Engagement team offers a robust CGT clinical trial site network of over 260 clinical sites worldwide with the necessary infrastructure and experience to conduct cell and gene therapy clinical trials, including facilities equipped for complex procedures like apheresis and cell processing.
We offer tailored strategies to support patient recruitment for CGT clinical trials including consent, engagement, diversity and compliance, and long-term follow-up.
To ensure patient participation is more accessible and less burdensome Allucent implements on-site, decentralized, and hybrid trial designs such as those that include DCT, telemedicine, remote monitoring, digital health tools and wearables.
Preferred Partners
Our Cell and Gene Therapy Solutions Center boasts a comprehensive list of preferred partners, ensuring seamless coordination, and superior support for CGT clinical trials including central labs, ePRO, IMP manufacturing to stringent GMP standards, and logistics and supply chain partners to manage the specialized requirements of cell and gene therapies.
Allucent Cell and Gene Therapy Experience
As a trusted cell and gene therapy CRO, our regulatory and CGT clinical trial experience encompasses the use of cell and gene therapies for the potential treatment of a variety of diseases, including immuno-oncology CAR-T and TCR therapies, rare diseases, infectious diseases, degenerative joint diseases, neurodegenerative diseases, and various immunodeficiency disorders.
Cell Therapies
50+
Cell Therapy Studies
465+
Global Sites
3300+
Patients Recruited for Cell Therapy Trials
Gene Therapies
40+
Gene Therapy Studies
290+
Global Sites
2115+
Patients Recruited for Gene Therapy Trials
All-time years of experience
Cross-Therapeutic Cell and Gene Therapy Expertise
Our extensive experience in cell and gene therapy clinical trials spans multiple therapeutic areas and includes a deep understanding of the ever-evolving needs within each one.
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