Gene & Cell Therapy IBC Support
Acacia Safety Consulting provides biological, chemical, and OSHA safety support for biopharma and academic institutions, CROs, hospitals, and clinics.
We are committed to providing our clients with customized, sustainable, and effective EHS solutions that are adaptable to various work environments, ensuring the well-being of employees and the environment.
At Acacia, we believe clinical trial sites deserve more than checklists and compliance paperwork. They deserve the confidence that every staff member — from nurses and pharmacists to environmental services and receiving — knows exactly how to stay safe while advancing groundbreaking therapies.
That’s why we put safety first. Because when staff are supported, informed, and confident, clinical trials move forward smoothly, research participants are better protected, and compliance naturally follows.
Running a clinical trial site is already demanding. Your staff are coordinating participants, managing room schedules, and preparing a wide range of investigational drugs — most of them small molecules, not biological agents. Adding gene and cell therapy trials into the mix brings entirely new safety requirements, risk profiles, and regulatory obligations.
Too often, sites are left with generic checklists, little communication, and staff confusion — leaving personnel unsure of the hazards they face, or the expectations placed on them.
We understand how frustrating that can be — because we’ve been in your shoes. That’s why Acacia works side-by-side with your staff, bringing clarity, training, and role-specific safety measures that integrate directly into your workflows — so the IBC feels like part of your team, not an outside burden.
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We go on-site — routinely, and when needed. Not just a virtual tour, not just a checklist. We start strong with an in-person safety assessment and return on a regular schedule (and whenever extra support is needed) to ensure everything stays safe and on track.
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Tailored risk assessments. We don’t stop at “one-size-fits-all.” We create role-specific and location-specific assessments — for nurses, pharmacists, environmental services, receiving dock workers, and anyone else who may encounter an investigational agent. From receipt, transport, and storage, to preparation, administration, and waste disposal — every step is covered.
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Integrated into your policies and procedures. Instead of layering on new language and documents, we align biosafety guidance with your existing clinical practices, signage, and hazard communication program. Staff learn in terms they already understand.
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Training that closes the gap. We make sure personnel aren’t just “told what to do,” but fully understand risks and procedures — reducing confusion, stress, and delays.
With more than four decades of collective experience in gene and cell therapy IBC reviews, Acacia brings unparalleled expertise to the table. We also bring 14 years of direct site-level experience establishing and managing IBCs at two hospitals — one adult and one pediatric — that not only conducted gene and cell therapy trials but also manufactured clinical-grade agents for use in those trials.
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This rare end-to-end perspective — spanning site-level IBC operations, clinical requirements, NIH/IBC regulatory expertise, and hands-on manufacturing — gives us a unique understanding of how to design IBC programs that are:
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Safety-first (protecting staff and study participants)
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Compliance-assured (meeting NIH, CMS, OSHA, and other accreditation requirements)
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Practical (usable and effective for your staff in their daily environment)
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Confidence that every role knows what to do, in their own workspace.
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Clear, integrated procedures for spills, exposures, and waste disposal.
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Regular on-site visits for proactive support and reassurance.
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Reduced stress and confusion for staff — smoother trial operations overall.
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Secure, electronic access to risk assessments and procedures tailored to each study and location.
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Better-informed, better-prepared sites = fewer delays in startup and review.
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Reduced risk of compliance gaps or miscommunication.
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Transparency through our electronic system — providing real-time visibility into study readiness at each site.
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Confidence that sites are not just compliant “on paper” but genuinely safe and prepared.
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Most IBC providers never set foot on your site. We do — routinely, and when needed.
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Most providers write generic risk assessments. We write tailored versions for each role and each physical location or room — from the receiving dock, to transport routes, to pharmacy prep, to administration, and finally waste disposal.
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Most providers leave staff unsure of procedures. We integrate biosafety directly into your existing policies, signage, and workflows, so staff know exactly what to do in their own environment.
When your staff are supported, informed, and confident, your clinical trials run more smoothly. By focusing on safety first, integrating biosafety into existing workflows, and maintaining a real on-site presence, Acacia ensures your IBC process not only meets regulatory requirements but truly supports your people.
Whether you’re a site preparing to launch your first gene or cell therapy trial, or an experienced research center looking for stronger support, Acacia can help.
Contact us today to learn how our IBC services can make your trials safer, smoother, and more successful.