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CELL & GENE THERAPY

Strategies for cutting-edge healthcare

Bringing innovative therapies to patients in need requires a robust strategy that links strong infrastructure and clinical insight with patient engagement solutions.

Jimmy El Hokayem Ph.D., VP, Program Development & Medical Insights

Cell and gene therapy (CGT) has moved well beyond early innovation, representing today’s most innovative clinical research for neurological disorders (Alzheimer’s and Parkinson’s Disease), oncological diseases, hematological conditions, and more. Focused on genetic material, cellular transfer, or even both interventions working together, the global CGT market is poised to provide next-level treatment options for patient care and rehabilitation.

Biorasi provides cutting-edge, clinical trial solutions that enable pharmaceutical and biotech companies to realize the future of CGT in healthcare. Across our 20+ year history as a CRO, BIorasi’s #OneTeam has optimized cell and gene clinical trials – leveraging key differentiators in logistical support, regulatory support, biosafety standards, clinical expertise, and patient engagement to meet trial goals and milestones.

Clinical Expertise and GuidanceClinical Expertise and Guidance

In addition to Biorasi’s experience in leading innovative clinical trials, we also engage our Medical and Scientific Affairs Department (MSA) and Scientific Advisory Board (SAB) team to provide guidance at all stages of your trial. Our MSA is highly experienced in critical eligibility and safety review activities. Biorasi’s SAB represents the best and brightest in clinical leadership – across key industry focus areas, including CGT. Dr. Ole Isacson (Neurology) and Dr. Robert S. Negrin (Hematology) are clinicians at the forefront of cell and gene clinical research and treatment.

Biorasi leaders also sit on scientific boards, working closely with rare disease and other foundations to bring cell and gene research one step closer to patient treatment.

Regulatory SupportRegulatory Support

CGT innovations often outpace the current regulatory oversight framework, which can result in clinical holds and trial delays. Biorasi stays up to date on regulatory guidance from the Food & Drug Administration (FDA), the Center for Biologics Evaluation and Research (CBER), and other global agencies. We confirm that all medical, ethical, and safety concerns are assessed prior to clinical trial launch, assist with potential protocol amendments, and collaborate quickly to minimize changes to the project timeline.

Patient EngagementPatient Engagement

Identifying patients who will remain committed throughout the length of a clinical trial can be a challenging prospect. Fortunately, Biorasi has resources and processes devoted specifically to help engage and educate patients for long-term, complex trials like CGT studies.

One-of-a-Kind Logistical SupportOne-of-a-Kind Logistical Support

As a leading, full-service CRO, our Clinical Operations and Project Management teams are focused on making strong connections – linking our project teams, sites, patients, and sponsors together. We customize our logistics strategies for each clinical trial, ensuring safe, secure, and timely solutions for CGT’s unique shipping and receiving needs.

Clinical Expertise and GuidanceBiosafety Standards

A crucial element of our CGT experience is meeting biosafety standards for all trial participants, from patients to clinical site staff and vendors. Biorasi’s Quality and Pharmacovigilance departments execute bio-risk management protocols to ensure biological integrity and containment strategies throughout the trial.