11.21.25 -- Regulatory Pathways With Real-Life Examples For Successful CGT Clinical Trials

On your journey to developing and executing a successful rare disease trial, it is critical to focus on patient experience and accessibility from the earliest stages of trial design.

Informed consent is essential in clinical research. However, when participants lose decisional capacity, a Legally Authorized Representative (LAR) is needed to provide consent and uphold ethical standards.

An RFP is more than a budget tool — it’s a strategic communication document that guides vendors, clarifies expectations, and enables informed, data-driven sponsor decisions.

GLP1 and neurology trials depend on detecting subtle retinal or neuro-ophthalmic changes early. By planning an imaging strategy upfront, sponsors can de-risk studies and protect critical endpoints.

Real-world data (RWD) is increasingly vital for advancing breast cancer research, and leveraging TA datasets allows researchers and clinicians to address pressing challenges.

High-quality biospecimens are the foundation of precision medicine success. Learn the five crucial steps—from planning to compliance—for a prospective biospecimen collection that is robust and accelerates your research.

Assimilate how MRN’s CEO Stuart Redding leads efforts to bring clinical trials to patients' homes, workplaces, and communities, enhancing accessibility across all trial phases.

CISCRP’s 2025 survey reveals key clinical trial insights: altruism drives participation, trust in pharma lags, and most are comfortable with AI analyzing medical data.

A biotech developing bispecific antibodies partnered with a flexible CRO to launch its first U.S. GI oncology trial, requiring strategic insight and full-service clinical support.

A CRO was engaged to help a biotechnology sponsor develop a novel oncology therapy design and execute a multicenter, open-label Phase 1/2 dose escalation and expansion study in advanced solid tumors.

Effective value chain planning for cell and gene therapies requires early decisions on manufacturing, complex cold storage solutions, flexible reimbursement models, and scalable partnerships.

Explore how to develop a strong packaging system, and learn more about why a reliable supply chain is critical for drug substance and drug product transport.

Uneven ice formation during bottle freezing creates a "Volcano Effect," pushing solutes into highly concentrated zones. This test-based study explains this risk to drug substance quality.