Your Site, Always Inspection-Ready
The Odom Group eliminates queries, prevents missed deadlines, and maintains 100% ICH-GCP compliance — so your team can focus on patients, not paperwork. Expert clinical research support and coordinator training, grounded in 25+ years of hands-on experience.
Ready to strengthen your site's research operations?
Schedule a free 30-minute discovery call — no obligation, no pressure.
Over Two Decades of Clinical Research Expertise
I founded The Odom Group, Inc. in 2017 after more than 25 years of hands-on clinical research experience. My career began in 2000 as a Study Coordinator in bone marrow transplant research — one of the most demanding and detail-intensive environments in clinical medicine.
Over the years I have held roles as a Clinical Research Associate (CRA), Clinical Trial Manager, and Senior CRA II — gaining comprehensive insight into every phase of the clinical trial lifecycle, from study start-up through close-out. I currently contract as a Senior CRA II while running The Odom Group.
The Odom Group was founded by a clinical research professional with a BSPH and 25+ years of industry experience — bringing both academic grounding and practical expertise to every engagement.
Meet Nicole Berry
Nicole Berry is a 25-year clinical research veteran who built her career from the ground up — starting at the bedside as a Study Coordinator in Bone Marrow Transplant and Hematology-Oncology, and advancing through every major role in the field: CRA, Senior CRA II, and Clinical Trial Manager. She has led Phase I–IV trials across Oncology, Hematology, and Rare Disease, managed multi-site studies at top CROs, and navigated FDA inspections without a single Form 483.
In 2017, she founded The Odom Group, Inc. to deliver that enterprise-level expertise directly to investigative sites — without the overhead of a full-time hire. She holds a BSPH from Kent State University and is a co-author of peer-reviewed research presented at the American Society of Hematology.
Areas of Expertise
A Career Built at the Site Level
Nicole's career started where clinical research actually happens — at the bedside. Her early years as a Study Coordinator in Bone Marrow Transplant and Hematology-Oncology gave her something most consultants lack: a firsthand understanding of the daily pressures sites face and what it takes to stay compliant under scrutiny.
Over the next two decades she advanced through every major role — CRA, Senior CRA II, Clinical Trial Manager — managing multi-site Phase I–IV studies, overseeing CRO operations, mentoring junior monitors, and steering sites through FDA inspections. She knows the work from every angle because she has done it at every level.
Today, The Odom Group partners with investigative sites across the country to resolve data backlogs, achieve audit readiness, and train the next generation of clinical research professionals — bringing enterprise-level rigor without the cost of a full-time hire.
Our Team
Every engagement is led by professionals who have held the same roles as the sites we serve.
Nicole Berry, BSPH
Founder of The Odom Group, Inc. since 2017, Nicole brings 25+ years of clinical research expertise — from Study Coordinator in bone marrow transplant research to Senior CRA II and Clinical Trial Manager. She has led Phase I–IV trials across Oncology, Hematology, and Rare Disease, and now directs client strategy, quality oversight, and every engagement the firm takes on.
“Sites don't fail inspections because they don't care — they fail because no one gave them the right structure. That's exactly what we fix.”
Pamela Trawick
With 30+ years spanning major pharmaceutical organizations, Pamela is the operational backbone of The Odom Group. Her expertise in clinical operations, site management, and regulatory compliance ensures every client engagement is delivered with precision, accountability, and audit-ready standards.
“Compliance isn't a checklist — it's a culture. My job is to help sites build that culture from the inside out.”
Carnell Reed Jr., BA
A certified CRA with 28 years of field monitoring experience at PAREXEL, Quintiles, Baxter, and Novo Nordisk, Carnell has overseen Phase I–IV trials across seven therapeutic areas. He delivers hands-on site training in GCP compliance, EDC data entry, and regulatory file management — equipping study teams to perform at an audit-ready standard from day one.
“Good monitoring isn't about catching mistakes — it's about building the habits that prevent them.”
Miya Johnson, BS, MBA
Miya is a Senior CRA whose decade-long career spans Novo Nordisk, PPD, PAREXEL, PRA, and IQVIA — with Phase I–III monitoring experience across eight therapeutic areas. Her background in risk-based site management and healthcare administration brings both clinical rigor and strategic perspective to every site she supports.
“Every site has unique pressures. My role is to understand those pressures and turn them into a plan that actually works in the real world.”
The Odom Group also works with a vetted network of senior clinical research contractors — all operating under the same standards of compliance, confidentiality, and professionalism that define our firm.
Comprehensive Site Support Services
Our team works collaboratively with sites, sponsors, and CROs to ensure documentation accuracy, compliance with ICH-GCP guidelines, and overall operational efficiency throughout the trial lifecycle.
Stay Inspection-Ready, Always
My flexible support model allows investigators and coordinators to focus on patient care and study execution while I ensure your documentation and regulatory files are always audit-ready. I understand the operational challenges many sites face — particularly related to regulatory documentation, TMF/ISF maintenance, study start-up preparation, and ongoing study management.
Regulatory Document Management
Comprehensive ISF/TMF organization and maintenance to ensure constant inspection readiness.
Study Start-Up Assistance
Expert preparation of essential documents to accelerate site activation and first patient enrollment.
eTMF & Veeva Vault Support
Proficient management of electronic Trial Master Files across leading platforms.
Monitoring Visit Preparation
Ensuring sites are fully prepared for CRA visits and assisting with action item resolution.
Source Document Review & QC
Rigorous review processes to maintain data integrity and protocol compliance.
Data Entry & EDC Support
Timely and accurate electronic data capture management across major EDC platforms — guaranteed within 5 business days of each subject visit, meeting sponsor and CRO deadlines every time.
Study Close-Out Preparation
Thorough document reconciliation and archiving support for seamless trial closure.
Remote Research Coordination
Flexible, off-site assistance to augment your existing research team on demand.
Signature Service Guarantee
5 Business Day EDC Data Entry — Guaranteed
Sponsors and CROs require data to be entered into the EDC within 5 business days of a subject visit. Missing this deadline generates queries, triggers monitoring findings, and puts your site at risk of increased oversight. I provide timely, accurate data entry so your site stays query-free, compliant, and inspection-ready — every time.
No commitment required — we will review your site's situation and respond within one business day.
A Curriculum Built From the Trenches of Clinical Research
I have spent 25+ years in every role a clinical research professional can hold — Study Coordinator, CRA, Clinical Trial Manager, and Senior CRA II. This training program translates that real-world experience into practical, inspection-ready knowledge for new and advancing Study Coordinators. Click any module below to see exactly what is covered and what you will be able to do after completing it.
Program Highlights
Who Should Attend?
Study Coordinator Training Pricing
All training is priced per person. Virtual sessions are delivered live via Zoom — link provided upon booking. In-person and hybrid formats are also available, scheduled around your availability.
Perfect for targeted skill-building on one specific topic area.
- One module of your choice
- ~2–3 hours of instruction
- Real-world case examples
- Q&A with Nicole Berry
- Available virtual or in-person
The complete 8-module curriculum — everything a Study Coordinator needs to excel.
- All 8 modules (16–24 hrs total)
- Delivered over 8 sessions
- FDA 21 CFR & ICH-GCP E6(R2)
- Hands-on document & EDC exercises
- In-person, virtual, or hybrid
- Certificate of completion
Same full 8-module curriculum, delivered to a small group — ideal for site teams.
- All 8 modules for up to 5 people
- Group total from $3,495
- Coordinated scheduling
- Group Q&A and discussion
- In-person, virtual, or hybrid
- Certificate of completion
Training your entire research site? The Odom Group offers custom site-wide engagements for investigative sites, CROs, and sponsor organizations — tailored to your protocols, SOPs, and regulatory environment. Pricing is scoped to your site size, format, and curriculum needs.
Support Services Are Custom-Quoted
Clinical research support engagements vary significantly based on scope, trial phase, site needs, and duration. The Odom Group offers flexible arrangements — hourly consulting, monthly retainers, and project-based engagements — all tailored to your specific situation. Reach out to discuss your site's needs and receive a custom proposal.
Partnering with Sites, Sponsors & CROs
I understand the operational challenges many sites face firsthand. My flexible support model is designed to integrate seamlessly with your existing staff.
Regulatory Compliance
I ensure documentation accuracy and compliance with ICH-GCP guidelines across all phases of your trial.
Operational Efficiency
My support reduces administrative burden on your clinical staff, allowing focus on patient care and study execution.
Inspection Readiness
I maintain your site in a state of continuous inspection readiness — no scrambling before an audit.
Why Choose The Odom Group?
See how partnering with The Odom Group compares to hiring a full-time staff member or relying on an already-stretched coordinator team.
| Factor | Full-Time Hire / In-House Staff | ✓ The Odom Group, Inc. |
|---|---|---|
| Cost | $60,000–$90,000/yr salary + benefits + overhead | Flexible hourly, retainer, or project-based — pay only for what you need |
| Availability | Fixed schedule; gaps during leave, turnover, or hiring delays | On-demand support — scale up or down based on study activity |
| Expertise | Varies by individual; may require additional training | 25+ years of hands-on CRA, CTM, and coordinator experience across multiple TAs |
| Regulatory Knowledge | Dependent on staff experience and training budget | Deep ICH-GCP, FDA, and sponsor-specific regulatory expertise built in |
| EDC Data Entry | Dependent on coordinator workload and competing priorities | Guaranteed within 5 business days of each subject visit — every time |
| Inspection Readiness | Reactive — often scrambling before audits | Proactive, continuous — your site is always audit-ready |
| Onboarding Time | Weeks to months for hiring, onboarding, and training | Rapid deployment — our team integrates with your site quickly |
| Commitment | Long-term employment contract | No long-term contracts — flexible engagement terms |
Ready to see the difference? Schedule a free 30-minute discovery call.
25+ Years of Clinical Research Experience
From first-in-human oncology trials to large-scale Phase III pivotal studies, my portfolio spans every phase of the clinical trial lifecycle across six therapeutic areas. Every engagement is backed by deep regulatory expertise and a commitment to data quality.
Oncology & Hematology
Bone marrow transplant, leukemia, lymphoma, and solid tumor trials across Phase I–III. Includes CAR-T cell therapy and targeted oncology agents.
Phase I, II, IIICardiovascular
Lipid management, heart failure, and anticoagulation studies. Experience with cardiac endpoint adjudication and complex ECG monitoring requirements.
Phase II, IIIInfectious Disease
Antiviral, antibacterial, and vaccine trials including HIV and respiratory disease programs with complex eligibility criteria and safety monitoring.
Phase II, III, IVNeurology & CNS
Alzheimer's disease, multiple sclerosis, and psychiatric disorder studies. Experience with cognitive assessments, patient-reported outcomes, and long-term follow-up.
Phase II, IIIEndocrinology & Metabolic
Type 2 diabetes, obesity, and thyroid disorder programs. Includes continuous glucose monitoring protocols and complex laboratory panel requirements.
Phase II, IIIRare & Orphan Diseases
Small patient population studies with expanded access protocols, compassionate use programs, and heightened regulatory documentation requirements.
Phase I, II, IIISignature Service Guarantee
5 Business Day EDC Data Entry — Guaranteed
Sponsors and CROs require data to be entered into the EDC within 5 business days of a subject visit. Missing this deadline generates queries, triggers monitoring findings, and puts your site at risk of increased oversight. I provide timely, accurate data entry so your site stays query-free, compliant, and inspection-ready — every time.
Case Studies
Real-world engagements with measurable outcomes. All client details are anonymized.
Cleared a 3-Month EDC Backlog in 14 Days
A Phase III oncology site was 90+ days behind on EDC entry after losing two coordinators mid-study. The sponsor had issued a formal warning letter citing repeated 5-business-day deadline violations.
Conducted a full data gap analysis, prioritized entries by visit date and query risk, and worked systematically through the backlog using the site's existing source documents — all remotely.
100% of outstanding data entered within 14 calendar days. Zero new deadline violations in the 6 months following engagement. Sponsor warning letter formally closed.
Prepared a Site for FDA Inspection in 3 Weeks
A community research site received a 30-day FDA inspection notice for an active oncology study. Their ISF had not been formally maintained in over a year — missing regulatory documents, outdated delegation logs, and incomplete consent tracking.
Performed a full ISF gap assessment against the protocol and sponsor requirements, organized all existing documents, identified and collected missing items, and built a document tracker the site could maintain independently going forward.
Site passed the FDA inspection with zero Form 483 observations related to the ISF. Site director reported the inspection as the smoothest in the site's history.
New Coordinator Running Independent Visits in 6 Weeks
A Phase II cardiology site hired a nurse with no clinical research experience as their sole study coordinator. The PI needed her running independent visits within 60 days to maintain study timelines.
Delivered a customized 6-week training program covering GCP fundamentals, protocol review, source documentation, ICF procedures, EDC entry, and monitoring visit preparation — tailored to the specific study and site SOPs.
Coordinator passed her first monitoring visit with no training-related findings. Site maintained enrollment timelines. PI requested a second training engagement for an incoming coordinator the following quarter.
Ready to see results like these at your site?
Schedule a Free ConsultationTrusted by Sites & Coordinators
✦ Placeholder testimonials — to be updated with real client feedback
Nicole's training gave our new coordinator the confidence and regulatory knowledge she needed from day one. The module on ISF maintenance alone saved us from a major finding during our next monitoring visit.
We brought Nicole in to help us prepare for a sponsor audit and she had our TMF organized and inspection-ready within two weeks. Her attention to detail and knowledge of ICH-GCP is exceptional.
The full 8-module program was exactly what I needed to transition from a clinical nursing role into research coordination. Nicole explains complex regulatory concepts in a way that actually makes sense.
Our site has worked with many consultants over the years, but Nicole's hands-on experience as both a coordinator and a CRA gives her a unique perspective. She understands both sides of the monitoring relationship.
Got Questions? We Have Answers.
Here are the questions I hear most often from sites, coordinators, and sponsors. Don't see yours? Reach out directly.
Let's Discuss How I Can Support Your Site
Whether you're an investigative site looking for operational support, a coordinator seeking training, or a sponsor/CRO exploring partnership opportunities — I'd love the chance to connect. Please reach out to schedule a brief introductory call.
Pick a time that works for you — no phone tag required.