Study Start-Up Guidance

What’s Included in Our Study Start-Up Guidance

Accelerate activation. Minimize delays. Maximize readiness.

At VertexCTM, our start-up support goes beyond task management—we act as your strategic partner to ensure every site is trial-ready, every document is in place, and every timeline is optimized. Whether you're launching a single-site study or a multi-center trial, our start-up guidance is built for speed, compliance, and scalability.

Feasibility & Site Selection Support

Our approach to feasibility and site selection is strategic, data-driven, and personalized—because the right sites make or break a study.

Custom Outreach Based on Study Needs
We don’t just blast emails. We tailor outreach based on:

Therapeutic area & indication expertise
Geographic diversity and access to patient populations
Historical performance metrics (enrollment rates, deviation history, audit outcomes)
Site capacity and resource availability

You get a curated list of high-potential sites instead of sifting through hundreds of options.

Feasibility Surveys & Pre-Qualification Screening
We create and distribute custom feasibility questionnaires aligned with your protocol requirements.
Our process includes:

GCP- and HIPAA-compliant digital forms
Site staff role verification (e.g., experience with specific assessments or devices)
Past performance documentation requests
Early identification of red flags (e.g., staff turnover, enrollment limitations)

We compile results into clean dashboards to speed decision-making.

PI Interest Tracking & Analysis Dashboards
We engage Principal Investigators (PIs) directly and track:

Response time & engagement level
Interest level (Yes, Maybe, No)
Key concerns or barriers to participation
Preferred site visit windows

You’ll receive a live-updated dashboard showing site status, responsiveness, and recruitment readiness.

Regulatory Document Preparation

We manage the essential documents that keep your study audit-ready and site-activated—without the last-minute scrambles. Our support ensures every form is accurate, complete, and submission-ready from day one.

Compliance without the chaos.

FDA Form 1572 (Statement of Investigator)
We streamline completion and validation of the 1572 by:

Pre-filling sponsor and site info to reduce errors
Cross-referencing against protocol and IRB docs
Ensuring each sub-investigator and facility is correctly listed
Delivering finalized forms with digital signature capability (if permitted)
Includes: 1572 logs and version control, aligned with submission timelines.

CVs, Licenses, and GCP Training Verification
We collect, verify, and organize:

PI and sub-I CVs (signed and dated within 2 years)
State medical licenses, DEA certificates (if applicable)
GCP training records (ICH E6 R2 compliant)
Any protocol-specific certification requirements
You’ll receive a complete Site Qualification Packet formatted and ready for submission or monitoring visits.

Site Delegation Logs & Financial Disclosure Forms
We prepare and QC:

Delegation of Authority Logs (DOA) with role descriptions
Signature and responsibility tracking across versions
Financial Disclosure Forms (FDFs) for all key personnel
Sponsor reconciliation and re-certification timelines
Plus, we ensure logs align with protocol tasks and include only staff with valid training and licensure.

IRB Submission & Tracking

Ensuring your study meets regulatory standards—seamlessly and on schedule.

We manage the full IRB submission lifecycle, helping you stay compliant and activate faster, whether you’re using a central IRB or coordinating through local IRBs.

Central or Local IRB Coordination

Determine the appropriate IRB path (central vs. local) based on sponsor requirements, study type, and site preference.
Coordinate all IRB communications, submissions, amendments, and renewals.
Manage site-specific consent form customizations (if local IRBs require) to ensure consistency across multi-site trials. Outcome: Quicker approvals, fewer back-and-forth delays, and early alignment across all sites.

Site Start-Up Project Plan

Milestone timelines and deliverable tracking
Communication plans to align stakeholders
Weekly progress reports and risk flagging

Full Packet Preparation
We assemble and quality-check all required materials before submission, including:

Finalized study protocol
Informed consent forms (ICFs) and HIPAA authorizations
Investigator Brochure (IB) or device manual
Recruitment materials (flyers, ads, social media posts)
PI CV, medical license, GCP training certificates
Site-specific documents (1572, financial disclosures, delegation logs)

Outcome:
Sponsor- and IRB-ready packets with complete, organized documentation to speed the review process.

Budget & CTA Support

Site budget template and review
Contract template tracking and redline support
Payment terms aligned with visit schedules

IRB Communication Logs and Decision Tracking

Maintain detailed logs of all communications (initial submissions, queries, approvals, conditions).
Track IRB decisions and response deadlines in real-time dashboards.
Proactively flag upcoming expirations, continuing reviews, and re-consent needs.

Outcome:
Full audit trails for every site and study, minimizing compliance risks and avoiding last-minute surprises.

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