Case Studies
Results that speak for themselves
Proven across phases, indications, and organizations
From biotech startups to global CROs, we’ve supported imaging trial teams with tailored consulting, high-stakes documentation, and scalable training—bringing clarity, precision, and speed to some of the industry’s most complex imaging challenges.
Imaging Documentation in 30 Days
Facing a compressed NDA timeline, a leading sponsor developing a prostate cancer imaging kit turned to Merigold to deliver the full imaging documentation package.
In just 30 days, we produced the Imaging Review Charter, Site Imaging Manual, Quality Monitoring Plan, reader training, and eCRF specs—accelerating enrollment, enabling on-time database lock, and supporting FDA acceptance of the sponsor’s NDA.
30 days to full document suite
Including charter, QC checklists, and training guides
Cross-functional input, zero bottlenecks
Including charter, QC checklists, and training guides
Regulatory-ready outputs
Built for speed and accuracy
Imaging Master Charter Framework
Merigold partnered with a leading pharmaceutical sponsor and global imaging CRO to transform the way BICR imaging documentation is developed across oncology portfolios. By introducing a modular Imaging Master Charter Framework, Merigold standardized core content while maintaining protocol-specific flexibility.
The result: faster study startups, fewer draft cycles, and improved data quality. With reusable, version-controlled appendices and streamlined methodology documents, teams saved significant time and reduced errors. Today, the framework supports multiple oncology portfolios, ensuring scalability, regulatory alignment, and operational efficiency as pipelines advance
Standardized yet flexible
A modular framework that streamlines imaging charters while adapting to protocol-specific needs
Efficiency at scale
Faster study startups, fewer draft cycles, and improved data quality across multiple oncology portfolios
Future-ready
Scalable design aligned to regulatory standards
Imaging Rescue Study
When a mid-sized immuno-oncology sponsor faced critical regulatory findings that halted their Phase II BICR reads, Merigold was brought in to lead a high-stakes remediation. Within compressed timelines, our team overhauled imaging charters and technical documentation, executed platform validation, trained readers, and aligned stakeholders on a compliant, harmonized process.
The result: a fully FDA-aligned read system implemented in record time, regulatory risks mitigated, and confidence in imaging data restored. This case highlights Merigold as a strategic partner—delivering swift, precise solutions under pressure
Rebuilt BICR infrastructure
Implemented a fully FDA-aligned read system in record time, restoring halted Phase II imaging reads
End-to-End Expertise
From documentation overhaul to platform validation and reader training, Merigold delivered compliant, streamlined processes
Proven Under Pressure
Mitigated regulatory risks and restored sponsor confidence
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