Expert Support for Clinical Research Sites

Tailored consulting services for efficient clinical research operations and compliance.

Clinical Research Site Consulting Services

Whether you’re launching a new study, training a new coordinator, or catching up after staff turnover, we provide tailored consulting and training to help your site stay compliant, efficient, and ready for success. We offer individual packages tailored to your site’s specific needs, or monthly support packages to help maintain efficiency and quality. We also offer a Site Rescue Package — for sites experiencing CRC turnover that require immediate assistance.

My services are primarily offered remotely, providing flexible guidance and oversight tailored to your site’s needs. If onsite support is required for hands-on training, site clean-up, or other activities, I am available on a limited basis. Travel expenses and an hourly rate apply for onsite work.

Below are package options designed to support your site’s needs, including monthly plans for continued oversight and guidance. Customized site support and à la carte services are also available to fit your specific operational goals.

Targeted Support Packages

Start-Up & Feasibility

Set your site up for success from day one.

Services include:

• Feasibility questionnaire support

• Site qualification visit preparation

• Start-up form completion and tracking

• Source document creation and customization

• Regulatory binder setup and maintenance

• IRB submission and renewal support

• Budget and contract review

• SIV preparation

CRC Mentorship & Training

Hands-on mentorship designed to build confidence and consistency across your CRC team.

Services include:

• Six personalized training sessions (virtual) Phone and email support

• Weekly check-ins and progress tracking

• Study conduct, data entry, and GCP training

• Mock monitoring preparation

• Post-training support for ongoing study needs

Operational and Administrative Support

Stay inspection-ready and on schedule with experienced oversight. For sites with 1-3 studies who have a Regulatory Specialist.

Services include:

• Visit readiness and scheduling checks

• Source data review and query resolution

• Deviation tracking and CAPA support

• Investigator oversight documentation

• Monitoring visit preparation and follow-up

• Weekly check-ins and progress tracking

• Ongoing CRC Support as needed

Regulatory Specialist Support

If the site does not have eReg the site will use the CRC for filing and gathering of signatures.

Start-Up & Maintenance:

• Regulatory binder setup and organization

• Essential document collection (CVs, 1572s, licenses, training logs)

• IRB submission support (initial, modification, continuing review)

• Document QC prior to SIV

• Delegation of duties and training log oversight

Compliance & Oversight:

• Routine binder QC and digital file checks

• Safety letter, deviation, and annual report tracking

• Audit and inspection preparation

Ongoing Support Options

Ideal for: Sites with experienced staff who need light oversight and organization.

Stay supported beyond your initial setup and organization.

Options include:

• Retainer-based consulting for ongoing guidance

• CRC support for basic assistance and mentorship

• Weekly compliance check-ins

Monthly Site Support Packages

Bronze – Basic Support

Ideal for: Sites with experienced staff who need light oversight and organization.

• Review of visit scheduling and visit documentation

• Site Source document and query review for accuracy

• SIV preparation guidance

• Time management and prioritization coaching

• Phone/email support for study-related questions

• Oversight of regulatory binder setup and maintenance

• Review of essential document completion (1572s, CVs, licenses, training logs)

• IRB renewal and safety report tracking support Guidance on submission timelines and templates

• General compliance and task oversight guidance

• Review of Site’s Study tracking tools (patient status logs, enrollment tracking)

• Monthly check-in calls to monitor study progress

• Recommendations for workflow and communication improvements

Silver – Standard Support

Ideal for: Sites with newer CRCs, moderate workloads, or sites juggling multiple studies.

• Weekly mentoring calls to review visits, queries, and data entry timelines

• Ongoing guidance on AE/SAE documentation and follow-up

• Query resolution and EDC troubleshooting

• Assistance with protocol deviation documentation

• Start-up document organization and submission tracking IRB submission assistance (initial, modification, and continuing reviews)

• Regulatory binder QC (ensuring up-to-date documents and signatures)

• Oversight of delegation logs, training records, and PI oversight documentation

• Sponsor and monitor communication support

• Monthly progress and workload reports

• Site readiness and compliance tracking

• Invoice and payment reconciliation review

• Coordination between departments (regulatory, clinical, finance)

• Best practice templates for site tracking tools and workflows

Gold – Comprehensive Support

Ideal for: Sites with high volume, multiple studies, or turnover needing full hands-on oversight. Sites needing oversite but not ready to hire a site director.

• Daily or on-call guidance for visit preparation and conduct

• In-depth review of data entry, queries, and AE/SAE reporting

• Development and management of subject visit tracking tools

• Direct oversight of protocol compliance and study visit workflows

• Mock monitoring or audit preparation sessions

• Full regulatory management and quality review

• Preparation and tracking of submissions to IRB and sponsor

• Oversight of essential document updates and filing

• Audit preparation and regulatory binder inspection readiness

• Comprehensive site oversight for all active studies

• Financial tracking, invoicing, and payment follow-up

• Staff performance and workload evaluation

• Coordination of sponsor and CRO communications

• Leadership support during transitions or high-volume periods

• CRC team oversight and quality review

• Staff workload evaluation

• Hiring and onboarding support

• Operational process optimization

Site Rescue Package

Ideal for: Sites facing backlogs, missed deadlines, or study disruptions caused by CRC turnover, staffing shortages, or operational gaps.

Overview: When a research site falls behind — due to staff transitions, data backlogs, or compliance issues — immediate and structured intervention is essential to restore sponsor confidence and study momentum.

The Site Rescue Package provides intensive, short-term support to stabilize operations, ensure regulatory compliance, and prepare the site for a successful transition back to steady-state operations.

This service is designed to get your site caught up, organized, and audit-ready — while helping your new or existing staff gain the structure and training needed to maintain progress once the rescue phase is complete.

What’s Included:

• Comprehensive site assessment to identify gaps, backlog areas, and urgent priorities

• Source document review and completion, ensuring all visits and data are up to date

• Regulatory binder review and submission catch-up, including essential document tracking and IRB updates

• Lab and specimen documentation review for proper reconciliation and chain of custody

• Visit scheduling and coordination support to resume participant flow efficiently

• Query resolution and data cleanup in EDC systems

• Study supply and equipment verification to ensure readiness for upcoming visits

• Sponsor/CRO communication support to provide progress updates and recovery plans

• CRC mentoring and workflow optimization to establish sustainable systems moving forward

Onsite & Transition Requirements: Because long-term success requires consistent staffing and follow-up, this package requires the site to have (or hire) a Clinical Research Coordinator (CRC) who will take ownership of the studies after the initial rescue phase.

• Consultant can provide onsite support for several days (as needed) to organize documentation, update systems, and meet with monitors or sponsors.

• The Consultant’s goal is to ensure that your site is compliant, organized, and fully prepared for sustainable ongoing operations after the rescue period ends.

Timeline:

Initial Phase (3–5 days): Onsite or remote intensive review, cleanup, and prioritization

Stabilization Phase (2–4 weeks): Remote follow-up, sponsor communication, and CRC mentoring

Transition Phase: Handoff to site’s assigned CRC with updated trackers, documentation, and best-practice workflows

Outcome:

By the end of the Site Rescue engagement, your site will have:

• All study documentation current and compliant

• A structured workflow for ongoing study conduct

• A trained CRC ready to maintain momentum

• Renewed confidence from sponsors and monitors

Ready to Get Started?

Pricing varies based on each site’s workload and study scope.
Let’s schedule a brief consultation to review your site’s needs and create a plan that fits your goals and budget.