Our Services
At VertexCTM, we provide strategic and hands-on clinical trial management solutions that bridge scientific rigor with operational excellence. Our lean, AI-assisted approach allows sponsors and research partners to streamline processes, reduce costs, and improve patient outcomes—all without compromising quality or compliance.
Regulatory Document Support
What we offer:
We provide full-spectrum regulatory support, ensuring that all trial-related documentation aligns with ICH-GCP guidelines and local regulations. Services include:
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Preparation and submission of regulatory binders
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IRB/EC submission packages and amendments
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Clinical Trial Agreement (CTA) tracking
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Maintenance of essential documents throughout the trial lifecycle
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e-Regulatory system guidance or light setup (optional)
Why it matters:
Delays in documentation can cost time and money. We ensure every piece is audit-ready and submitted accurately and efficiently.
Study Start-Up Guidance
What we offer:
Our support begins at pre-activation. We help navigate the complexities of startup and minimize bottlenecks through:
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Site identification and qualification
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Startup timeline development and tracking
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Coordination of ethics approvals
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Investigator packet review and support
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Pre-study visits (PSV) coordination support
Why it matters:
The start-up phase is one of the most delay-prone areas in clinical research. We keep it tight, clean, and on schedule.
Feasibility & Site Readiness Coordination
What we offer:
We assess sites not just for capacity but for compatibility, helping you select high-performing research locations. Our services include:
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Feasibility questionnaire development and site outreach
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Assessment of PI interest, patient population, and trial fit
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Site qualification call coordination
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Site readiness tracking and communication
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Metrics reporting for decision-making
Why it matters:
Right-site selection sets the tone for the entire trial. We help you choose partners who can actually deliver.
Patient Recruitment Strategy Design
What we offer:
Using behavioral insights, community engagement, and AI-driven tools, we build tailored strategies to meet your enrollment goals. Services include:
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Recruitment material design (flyers, digital ads, videos)
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Diverse patient population outreach strategies
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Partnerships with community organizations and patient advocates
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Social media strategy guidance
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Retention planning: patient support pathways, site tools, and visit optimization
Why it matters:
Over 80% of trials fail to meet enrollment targets. We help you get ahead of the curve with smarter recruitment and sustainable retention.
Project Management Oversight
What we offer:
We act as a single point of coordination to ensure seamless communication and operational alignment across all stakeholders. Services include:
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Study planning and milestone tracking
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Communication between sponsors, CROs, and site teams
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Risk identification and mitigation strategies
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Budget adherence and deliverables review
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Regular status reporting and escalation management
Why it matters:
You don’t need more meetings. You need clarity, execution, and control—without bloat. We provide all three.
Specialized Support for Neurodivergent & Rare Disease Trials
What we offer:
We understand the sensitivities, complexities, and nuances of engaging neurodivergent participants and rare disease populations. Support includes:
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Inclusive protocol and consent design consultation
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Site training on communication and accessibility needs
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Participant experience design (environment, communication, sensory-friendly options)
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Tailored recruitment strategies for hard-to-reach populations
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Community and caregiver engagement initiatives
Why it matters:
True innovation includes everyone. Our commitment to inclusivity ensures no patient is left behind in the pursuit of scientific progress.
