Services
Imaging trials are complex. We introduce clarity.
Turn imaging into a strength—not a scramble
Merigold’s consulting services provide clinical teams with the specialized expertise needed to confidently design, document, and execute imaging components of clinical trials. From Imaging Charter development to regulatory strategy, we partner with sponsors, CROs, and iCROs to ensure high-quality imaging data is captured, interpreted, and delivered on time—every time.
Whether you need end-to-end support or targeted expertise, Merigold offers flexible, responsive, and peer-reviewed consulting that elevates imaging from a risk to a strategic advantage.
Everything you need to get imaging right
Merigold’s consulting services cover the full lifecycle of imaging in clinical trials—from protocol development and strategic planning to documentation, training, and vendor oversight.
We organize our consulting offerings into four core areas:
Imaging Strategy & Study Design
We help trial teams design robust imaging components aligned with protocol endpoints, regulatory expectations, and operational feasibility.
- Protocol development (general and imaging-specific)
- SOP/process evaluation and optimization
- Response criteria consulting (e.g., RECIST 1.1, Lugano, RANO, PCWG3, etc.)
- Modality- and indication-specific strategy
- Vendor evaluation, selection, and oversight
Document Development & Medical Writing
Our writing services are delivered by imaging SMEs—not generalists. Every document we author or review is peer-reviewed and built for clarity, regulatory alignment, and operational utility.
Imaging Training & Enablement
In addition to our eLearning products, we design and deliver customized training for every imaging stakeholder—sites, CRAs, investigators, independent reviewers, internal teams, and vendors.
- Live or recorded training sessions
- Indication-, modality-, or response criteria-specific instruction
- Investigator, CRA, and site training
- Independent reviewer training and calibration
- Internal SME development
Oversight & Quality Assurance
We support trial teams in implementing rigorous QC of central read results, documentation audit, and oversight processes that reduce risk and enhance data integrity.
- Medical QC workflows and checklist design
- Reader performance monitoring
- Read paradigm design and validation
- Review of vendor QC workflows and outputs
What we don’t do
At Merigold, we specialize in what we do best—and we’re clear about what we do not provide:
- Full-service clinical trial execution or site management
- Imaging core lab operations (e.g., image QC, independent review)
- General medical writing outside of imaging-specific contexts
We work best as a specialized partner—collaborating with sponsors, CROs, and iCROs to ensure the imaging components of your trial are strategic, compliant, and delivered with clarity.
Speed + Flexibility
We tailor our services to your team, timeline, and trial.
Our clients count on us for:
- Fast turnaround imaging charters and study documents
- Responsive support
- Phased consulting across trial planning, execution, and vendor oversight
Our modular approach and peer-reviewed process ensure precision without bottlenecks—and quality without compromise.
When to engage us
Merigold can step in early, late, or anywhere in between.
Here are the moments when clients find our consulting services most valuable:
01.
During Protocol Development
When you’re designing a trial and need expert input on imaging endpoints, acquisition schedules, or response criteria.
02.
During Vendor Selection or Oversight
When you need help assessing imaging vendors, setting up central read paradigms, or defining imaging-related SOPs.
03.
During Business Development or RFP Response
When you’re responding to an RFP for an imaging-heavy study or preparing for a bid defense—and need fast, credible support that sets your proposal apart.
04.
Before Drafting Imaging Documents
When you’re ready to scope or write charters, manuals, or QC checklists—and want to get them right the first time.
05.
When Your Team Needs Training
When sites, readers, or CRO partners need onboarding or upskilling in imaging workflows, response criteria, or QC procedures.
06.
When Things Get Off Track
When you’re facing delays, inconsistencies, or regulatory pushback on imaging data—and need clarity and recovery support.
Rescue study prevention — Why wait for a crisis to get expert help?
Merigold is often brought in to rescue struggling imaging trials—but we’d rather help you avoid the fire drill altogether. Our proactive involvement during protocol design, vendor setup, and document development prevents the delays, deviations, and data issues that often trigger remediation. With Merigold, imaging becomes a strategic asset—not a source of trial risk.
Build capability while you execute
Pair your project with Bloom or eLearning to reduce repeat work, shorten timelines, and grow team confidence from the inside out.
Preview Bloom AI
Be among the first to experience Bloom, Merigold’s AI-powered platform for imaging documentation.
Upskill with Merigold eLearning
Get notified when our imaging training modules and downloadable tools go live—covering everything from response criteria to reviewing imaging charters and more.
Where strategy meets execution
These snapshots show how we’ve helped sponsors, CROs, and iCROs overcome bottlenecks, avoid rework, and elevate the imaging component of their trials.
Imaging Rescue Study
Rapid Redevelopment of BICR Infrastructure
When a high-stakes oncology trial stalled due to imaging failures, Merigold rebuilt the BICR infrastructure in just weeks—delivering compliant, high-quality imaging data that enabled an on-time NDA submission.
Prostate Cancer NDA Trial
Imaging Documentation in 30 Days
Faced with aggressive NDA timelines, Merigold developed a full imaging document suite across multiple stakeholders in under 30 days—accelerating data delivery for a landmark prostate cancer submission.
Master Charter Innovation
Standardizing Imaging Across Trials
Merigold partnered with a global CRO and top-10 pharma sponsor to pioneer a modular Master Charter framework—streamlining documentation across oncology trials while ensuring consistency and regulatory alignment.
Let’s get your imaging strategy right—starting now
We’re ready when you are. Whether you need full support or a quick consult, Merigold brings clarity and speed where it counts.