Answers for your clinical research questions

We are not a short-term aggregator or roll-up. Our commitment is long-term — to each site, each partnership, and the network as a whole. We invest in relationships that are mutually rewarding, sustainable, and built to last.

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Support & information

Answers to your top questions

Find clear, straightforward answers to common questions about our clinical research process, participation, and what to expect.

What is Independence Clinical Research Alliance (ICRA)?

Independence Clinical Research Alliance is a Site Management Organization (SMO) built exclusively to support independent clinical research sites while preserving their ownership, autonomy, and long-term value.

ICRA brings together a curated network of research-only sites and provides the operational infrastructure, regulatory oversight, business development support, and execution discipline typically found in large enterprises - without forcing consolidation or loss of control.

We exist to make independent sites stronger, more competitive, and more reliable partners for Sponsors and CROs.

How does ICRA help sites securestudies and grow sustainably?

ICRA actively supports study procurement and business development -this is not a passive referral model.

We help sites by:

  • Positioning them as part of a     vetted, accredited research network
  • Presenting realistic, data-driven     feasibility responses
  • Matching protocols to each site’s     true strengths and capacity
  • Leveraging long-standing Sponsor     and CRO relationships
  • Supporting budget strategy and     negotiation as a network

Because ICRA leadership has built and scaled healthcare and researchenterprises valued in the tens of millions of dollars, study procurementis approached strategically - not opportunistically.

How does ICRA support enrollment strategy and execution?

Enrollment is treated as an execution discipline, not a guess.ICRA supports sites with:

• Protocol-specific enrollment risk assessment

• Realistic forecasting based on site data and demographics

• Workflow optimization for screening, consent, and retention

• Ongoing enrollment monitoring and corrective guidance

• Knowledge sharing across the network on what actually works

Our team has sat on both sides of the table - as site operators and Sponsor/CRO partners - which allows us to align expectations with reality and drive results.

Why should Sponsors and CROs trust the ICRA network?

Sponsors and CROs partner with ICRA because the network delivers predictability,transparency, and regulatory confidence.

ICRA provides:

  • A vetted network of research-only sites
  • Standardized quality and regulatory expectations
  • Centralized oversight and escalation pathways
  • Clear visibility into site readiness and performance
  • Consistent documentation and compliance practices

Our accreditation framework and ongoing quality oversight reduce variability and risk while preserving the flexibility and access that independent sites provide.

How does ICRA ensure regulatory excellence and transparency?

Regulatory excellence is non-negotiable at ICRA.

We ensure:

  • GCP compliance for all delegated staff
  • Standardized SOP frameworks and document control
  • Audit-ready regulatory binders or eTMF structures
  • Clear delegation, training, and oversight documentation
  • Transparent access for monitors and auditors

Monitors working with ICRA sites experience organized documentation, responsive teams, and clear escalation pathways - allowing them to focus on oversight rather than remediation.

How does ICRA prioritize participant safety and confidentiality?

Participant safety and confidentiality are the highest priorities acrossthe ICRA network.

All ICRA sites must demonstrate:

  • Robust informed consent processes
  • Clear AE/SAE identification and reporting workflows
  • Documented PI medical oversight
  • HIPAA-aligned privacy and data protection controls
  • Incident escalation and corrective action procedures

Because ICRA leadership has been hands-on site operators, safety is treated as a daily operational responsibility - not a compliance checkbox.

What makes ICRA’s leadership team different from other SMOs?

ICRA is led by hands-on operators, not consultants oradministrators.

The ICRA team has:

  • Built and scaled healthcare and research enterprises valued in the tens of millions of dollars
  • Led operations, marketing, capital raising, business development, and M&A
  • Negotiated directly with  Sponsors, CROs, and investors
  • Operated clinical research sites     under real regulatory and enrollment pressure

This experience allows ICRA to bridge the gap between strategy andexecution - and to share that knowledge directly with every site in thenetwork.

How does ICRA share its expertise with sites?

ICRA is execution-focused and knowledge-driven.

We actively share:

  • Operational best practices
  • Enrollment and retention strategies
  • Regulatory risk mitigation approaches
  • Budget and contract strategy insights
  • Business development and growth frameworks

Our success depends on the success of each site. We pledge our experience, systems, and leadership to help every site perform at its highest level - and every study execute successfully.

Why should Sponsors and CROs trus tthe ICRA network?

Sponsors and CROs partner with ICRA because the network delivers predictability, transparency, and regulatory confidence.

ICRA provides:

  • A vetted network of research-only sites
  • Standardized quality and regulatory expectations
  • Centralized oversight and escalation pathways
  • Clear visibility into site readiness and performance
  • Consistent documentation and compliance practices

Our accreditation framework and ongoing quality oversight reduce variability and risk while preserving the flexibility and access that independent sites provide.

How does ICRA ensure regulatory excellence and transparency?

Regulatory excellence is non-negotiable at ICRA.

We ensure:

  • GCP compliance for all delegated staff
  • Standardized SOP frameworks and document control
  • Audit-ready regulatory binders or  eTMF structures
  • Clear delegation, training, and oversight documentation
  • Transparent access for monitors  and auditors

Monitors working with ICRA sites experience organized documentation, responsive teams, and clear escalation pathways - allowing them to focus on oversight rather than remediation.

How does ICRA prioritize participant safety and confidentiality?

Participant safety and confidentiality are the highest priorities acrossthe ICRA network.

All ICRA sites must demonstrate:

  • Robust informed consent processes
  • Clear AE/SAE identification and reporting workflows
  • Documented PI medical oversight
  • HIPAA-aligned privacy and data protection controls
  • Incident escalation and  corrective action procedures

Because ICRA leadership has been hands-on site operators, safety is treated as a daily operational responsibility - not a compliance checkbox.

What makes ICRA’s leadership team different from other SMOs?

ICRA is led by hands-on operators, not consultants oradministrators.

The ICRA team has:

  • Built and scaled healthcare and research enterprises valued in the tens of millions of dollars
  • Led operations, marketing,  capital raising, business development, and M&A
  • Negotiated directly with Sponsors, CROs, and investors
  • Operated clinical research sites under real regulatory and enrollment pressure

This experience allows ICRA to bridge the gap between strategy and execution - and to share that knowledge directly with every site in the network.

What support is available during a study?

Q9. How does ICRA share its expertise with sites?

ICRA is execution-focused and knowledge-driven.

We actively share:

  • Operational best practices
  • Enrollment and retention strategies
  • Regulatory risk mitigation approaches
  • Budget and contract strategy insights
  • Business development and growth frameworks

Our success depends on the success of each site. We pledge our experience, systems, and leadership to help every site perform at its highest level - and every study execute successfully.

How does ICRA protect site independence?

Protecting independence is foundational to ICRA.

Sites in the ICRA network:

  • Retain full ownership and branding
  • Maintain direct Sponsor and CRO relationships
  • Control staffing, finances, and internal operations
  • Choose which studies to  participate in

ICRA does not acquire sites, dictate clinical decisions, or impose rigid corporate structures. Instead, we provide leverage, infrastructure, and expertise that allow independent sites to compete with large networks -without becoming one.

How does ICRA protect site independence?

Protecting independence is foundational to ICRA.

Sites in the ICRA network:

  • Retain full ownership and     branding
  • Maintain direct Sponsor and CRO     relationships
  • Control staffing, finances, and     internal operations
  • Choose which studies to     participate in

ICRA does not acquire sites, dictate clinical decisions, or impose rigidcorporate structures. Instead, we provide leverage, infrastructure, andexpertise that allow independent sites to compete with large networks -without becoming one.

Why should Sponsors and CROs trus tthe ICRA network?

Sponsors and CROs partner with ICRA because the network delivers predictability,transparency, and regulatory confidence.

ICRA provides:

  • A vetted network of research-only     sites
  • Standardized quality and     regulatory expectations
  • Centralized oversight and     escalation pathways
  • Clear visibility into site     readiness and performance
  • Consistent documentation and     compliance practices

Our accreditation framework and ongoing quality oversight reducevariability and risk while preserving the flexibility and access thatindependent sites provide.

How does ICRA ensure regulatory excellence and transparency?

Regulatory excellence is non-negotiable at ICRA.

We ensure:

  • GCP compliance for all delegated     staff
  • Standardized SOP frameworks and     document control
  • Audit-ready regulatory binders or     eTMF structures
  • Clear delegation, training, and     oversight documentation
  • Transparent access for monitors     and auditors

Monitors working with ICRA sites experience organized documentation,responsive teams, and clear escalation pathways - allowing them to focus onoversight rather than remediation.

How does ICRA prioritize participant safety and confidentiality?

Participant safety and confidentiality are the highest priorities acrossthe ICRA network.

All ICRA sites must demonstrate:

  • Robust informed consent processes
  • Clear AE/SAE identification and     reporting workflows
  • Documented PI medical oversight
  • HIPAA-aligned privacy and data     protection controls
  • Incident escalation and     corrective action procedures

Because ICRA leadership has been hands-on site operators, safety istreated as a daily operational responsibility - not a compliance checkbox.

What makes ICRA’s leadership team different from other SMOs?

ICRA is led by hands-on operators, not consultants oradministrators.

The ICRA team has:

  • Built and scaled healthcare and     research enterprises valued in the tens of millions of dollars
  • Led operations, marketing,     capital raising, business development, and M&A
  • Negotiated directly with     Sponsors, CROs, and investors
  • Operated clinical research sites     under real regulatory and enrollment pressure

This experience allows ICRA to bridge the gap between strategy andexecution - and to share that knowledge directly with every site in thenetwork.

How does ICRA share its expertise with sites?

ICRA is execution-focused and knowledge-driven.

We actively share:

  • Operational best practices
  • Enrollment and retention strategies
  • Regulatory risk mitigation approaches
  • Budget and contract strategy insights
  • Business development and growth frameworks

Our success depends on the success of each site. We pledge our experience, systems, and leadership to help every site perform at its highest level - and every study execute successfully.

REGULATORY & COMPLIANCE EXCELLENCE

Clarity in every clinical trial

Regulatory operations are not optional — they are foundational.
We provide:

Critical regulatory guidance

GCP and protocol compliance oversight

SOP development and alignment

Audit readiness and risk mitigation

Long-term regulatory strategy

How do you maintain data integrity?

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Advancing research. Improving lives.

Accelerating clinical trials with expert care and operational excellence. We deliver high-quality, patient-focused studies to drive medical innovation and better outcomes.