From first contact to final report, every engagement with The Odom Group, Inc. follows a structured, documented methodology designed to bring your site to — and keep it at — full audit-readiness. No guesswork. No surprises. Just a clear path to compliance.
Engagement Timeline
Every engagement follows the same six-phase methodology — adapted to your site's specific needs, but never improvised. From the first discovery call to the final knowledge transfer, you always know exactly where you are, what comes next, and what we have committed to deliver.
Average time from signed agreement to active mobilization
Every engagement is fully scoped and documented before work begins
FDA observations across all sites we have prepared for inspection
Every engagement begins with a no-obligation consultation to understand your site's current state, upcoming milestones, and specific pain points. We review your trial portfolio, regulatory binder status, EDC data quality, and any outstanding queries or monitoring findings.
Written Site Assessment Summary with prioritized recommendations
We document everything from day one. The assessment summary becomes the baseline against which all subsequent improvements are measured.
Based on the discovery findings, we develop a tailored Scope of Work that defines exactly what will be done, by whom, on what timeline, and at what cost. No vague retainers or open-ended commitments — every engagement is clearly scoped before work begins.
Signed Client Services Agreement + Detailed SOW with timeline
A written SOW is your protection as much as ours. It establishes clear expectations and prevents scope creep — a common source of budget overruns and relationship friction.
Once the agreement is signed, we mobilize quickly. Our team gains access to your systems, conducts a thorough baseline audit of your regulatory files and data, and establishes the working protocols that will govern the engagement.
Baseline Audit Report with gap analysis and remediation priority matrix
The baseline audit is the foundation of everything that follows. It gives us — and you — a clear, documented picture of where you stand before any remediation begins.
This is where the work happens. Our team works directly in your systems to resolve outstanding issues, close queries, organize regulatory files, and bring your documentation to audit-ready standard. For EDC engagements, we guarantee data entry within 5 business days of visit completion.
Weekly progress reports with metrics: queries closed, documents filed, open items
Every action we take is documented with a timestamp and rationale. If an FDA inspector or sponsor monitor asks why a document was filed a certain way, we have the answer — in writing.
Before any monitoring visit, audit, or FDA inspection, we conduct a structured inspection readiness review. This is a systematic check of every regulatory requirement — not a quick scan, but a methodical, protocol-by-protocol, document-by-document verification.
Inspection Readiness Report with pass/fail status by regulatory domain
We have prepared sites for FDA inspections with zero Form 483 observations. The inspection readiness review is the same process we use internally — now applied to your site.
At the conclusion of a project engagement, we do not simply hand over a report and leave. We conduct a structured knowledge transfer to ensure your team can maintain the standards we have established. For retainer clients, we provide continuous oversight and proactive compliance monitoring.
Final Engagement Report + SOP Recommendations + Training Summary
The goal is not dependency — it is capability. We want your team to be stronger after working with us than before. That is what a real consulting partner delivers.
Audit-readiness is not a one-time event — it is a continuous state. Every process we follow is designed to keep your site compliant not just for the next monitoring visit, but for every visit, every audit, and every inspection that follows.
All documentation practices align with the current ICH Good Clinical Practice guidelines, including source data verification, audit trail integrity, and investigator oversight requirements.
Our regulatory file management and data entry practices comply with FDA regulations governing electronic records, informed consent, financial disclosure, IRB oversight, and IND requirements.
Data entered within 5 business days of visit completion — documented, timestamped, and verifiable. This is a commitment, not a target.
Complete the form and a member of The Odom Group, Inc. team will respond within one business day. There is no obligation — just a clear, honest conversation about what your site needs and how we can help.
We review your submission and prepare for your site's specific situation
You receive a call or email within 1 business day (Mon–Fri, 8am–5pm ET)
We schedule a free 30–60 minute consultation at your convenience
You receive a written site assessment and scope of work — no commitment required
Prefer to call or email directly?
Reach us at [email protected] or schedule directly via Calendly. Business hours: Monday–Friday, 8:00 AM–5:00 PM ET.