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.
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
Study Conduct & Oversight
Stay inspection-ready and on schedule with experienced oversight.
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
Operational & Administrative Support
Simplify operations so your team can focus on patients and data.
Services include:
Budget and payment tracking
Sponsor payment reconciliation
Study close-out support
Delegation of duties and role optimization
Workflow and process improvement
Site Management & Oversight
Get interim or ongoing oversight from an experienced research professional.
Services include:
Interim site management during turnover
CRC team oversight and quality review
Staff workload evaluation
Hiring and onboarding support
Operational process optimization
Ongoing Support Options
Stay supported beyond your initial setup or training.
Options include:
Retainer-based consulting for ongoing guidance
Virtual document and data review
Monthly compliance check-ins
Monthly Site Support Packages
Bronze – Basic Support
Ideal for: Sites with an experienced CRC who need guidance.
Includes:
Weekly check-ins
Phone/email support
Document review (source, regulatory binder, logs)
SIV prep and readiness review
Light oversight on data entry and timelines
Silver – Standard Support
Ideal for: Sites with newer CRCs or moderate workload.
Includes everything in Bronze, plus:
Biweekly or weekly detailed meetings
Review and assistance with all startup documents and regulatory submissions
Source document creation and CRC training
Query management guidance
Sponsor communication support as needed
Gold – Comprehensive Support
Ideal for: Sites with a new CRC wanting to build a successful path for your CRC workload, Sites with multiple studies, high workload, or recent CRC turnover.
Includes everything in Silver, plus:
Full hands-on oversight from feasibility to SIV
Daily or on-call support for CRCs
Source and regulatory binder development
Tracking startup timelines, vendor setup, and site readiness
Monitoring visit preparation and follow-up
Workflow setup and ongoing CRC mentorship
Site Rescue Package
Ideal for: Sites struggling to catch up due to CRC turnover, missed deadlines, or study delays.
Includes:
Rapid assessment of current site status and backlog
Source document review and completion
Regulatory binder and submission catch-up
Visit scheduling and coordination support
Query resolution and data cleanup
CRC mentoring and workflow optimization
Sponsor communication support to bring site back on track
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.
Frequently Asked Questions:
What types of sites do you work with?
We work with sites of all sizes and therapeutic areas — from single-study practices to large multi-study sites — providing tailored solutions based on your specific needs and resources.
Can I choose only the services I need?
Yes! We offer individual, customized packages so you only pay for the services your site requires. You can also combine services into a monthly support package for ongoing assistance.
What is a Site Rescue Package?
Our Site Rescue Package is designed for sites struggling due to CRC turnover or delays. It provides rapid assessment, regulatory and source document catch-up, visit scheduling support, and CRC mentorship to get your site back on track.
How do monthly packages work?
Monthly packages provide consistent, hands-on support for your site. Packages are tiered (Bronze, Silver, Gold) based on the level of oversight and assistance needed. Packages can be customized for study volume, staff experience, and workload.
Do you provide on-site support or virtual support?
We offer both on-site and remote support depending on your site’s needs. On-site support is ideal for training, monitoring prep, and Site Rescue activities. Remote support works well for ongoing mentoring, document review, and check-ins.
How is pricing determined?
Pricing is based on the scope of work, study complexity, and level of support required. Packages start at $500/month for basic support, with higher tiers for more comprehensive assistance. Site Rescue and custom packages are priced based on workload.
Can you help with audits or inspections?
Yes! We provide internal QC audits, mock inspections, SOP review, CAPA development, and monitoring visit preparation to ensure your site is fully compliant and inspection-ready.
How do we get started?
Simply reach out to schedule a brief consultation. We’ll review your site’s needs, discuss options, and create a tailored plan that fits your goals, timeline, and budget.
Do you offer guarantees?
We don’t guarantee specific outcomes such as enrollment numbers or sponsor approvals, as these depend on factors beyond our control. However, we do guarantee professional, high-quality support, timely communication, and a commitment to helping your site meet deadlines, maintain compliance, and operate efficiently.
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