SPONSORS
& CROs
One Site Network. Smarter Study Execution.
M3 Wake Research connects sponsors and CROs with experienced investigators, diverse patient populations, centralized study support, and consistent execution across a wholly owned and operated clinical research site network.
From feasibility and activation through recruitment, retention, and closeout, our teams work as one integrated network to help studies start efficiently, enroll effectively, and maintain quality at every stage.
An Integrated Clinical Research Site Network
40+ Years of Clinical Research Experience
- 16+ Wholly Owned Sites Across 9 States
- 70+ Investigators
- 15+ Therapeutic Areas
- 670+ Studies Completed
- 1M+ Patient Database
- 30,000+ Participants Randomized
- 30+ Direct-Access Partnerships Nationwide
One Network. One Accountable Operating Model.
Our sites are supported by centralized leadership, standardized operating procedures, integrated systems, and shared performance expectations. This creates greater consistency across locations while preserving the local expertise that drives participant trust and engagement.
Sponsors and CROs benefit from:
- A single point of contact for multisite feasibility
- Centralized contract and budget negotiation
- Consistent reporting and escalation pathways
- Central quality and operational oversight
- Network-wide recruitment planning
- Coordinated regulatory submissions
- Dedicated multisite project coordination
Feasibility and Site Selection
Protocol requirements are evaluated against investigator experience, patient access, site infrastructure, therapeutic capabilities, and known patient populations.
Contracts, Budgets, and Regulatory
Centralized teams coordinate contract and budget negotiations, regulatory submissions, and central IRB activity across participating sites.
Recruitment and Enrollment
Recruitment planning begins early and combines direct-access partnerships, physician referrals, centralized recruitment, and embedded site support.
Study Execution and Quality
Central oversight supports consistent operations, investigator engagement, documentation quality, monitoring follow-up, and timely issue escalation.
Retention and Closeout
Participant engagement and centralized operational support continue through study completion and closeout.
Partnership-Powered Patient Identification
Expanded Patient Access Through Trusted Clinical Relationships
M3 Wake Research combines a network patient database of more than 1 million patients with 30+ direct-access partnerships across the United States.
These established relationships expand access to clinically relevant and diverse patient populations. They also help our teams evaluate potential study opportunities based on therapeutic alignment, geographic reach, investigator expertise, and known patient populations.
Our partnership-supported approach includes:
- Protocol-aligned population identification
- Access to established clinical and community patient populations
- Physician-supported patient identification and outreach
- Direct collaboration with partner practices
- Structured and unstructured clinical data analysis
- Trusted communication through established patient relationships
- Feasibility supported by real patient population data
These partnerships strengthen our ability to identify potential participants beyond individual site databases while preserving the clinical relationships that support trust, responsiveness, and continued engagement.
AI-Powered Patient Intelligence and Trial Acceleration
Connecting Patient Identification With Responsive Human Engagement
M3 Wake Research combines Cardea Health’s patient intelligence platforms, AI-supported recruitment technology, and experienced recruitment teams to support the participant journey from identification through enrollment.
This integrated approach helps sponsors and CROs assess patient populations, identify potentially eligible participants, initiate timely outreach, streamline pre-screening, and connect individuals with human support when needed.
Patient Intelligence and Identification
Cardea Health’s integrated technology platforms transform outpatient data into actionable study opportunities. M3 Wake Research can evaluate patient populations, identify potentially eligible participants, and develop longitudinal clinical insights to support feasibility, recruitment planning, and study optimization.
ScreenFlow+: Accelerated Patient Identification
ScreenFlow+ uses AI-powered patient matching to identify potentially eligible trial participants within existing patient populations and deliver curated candidate lists for site review.
Key capabilities include:
- Protocol-aligned identification of potentially eligible patients in days not months
- Secure integration for structured and unstructured EMR data analysis
- Reduced manual chart review and screening workload
- More efficient recruitment and enrollment execution
- HIPAA-compliant, enterprise-grade security
- Faster screening and enrollment execution
INSIGHT™: Longitudinal Clinical Intelligence
INSIGHT™ transforms outpatient data into longitudinal clinical intelligence that can inform feasibility, cohort discovery, study planning, and real-world evidence generation.
Key capabilities include:
- Analysis of physician notes, laboratory results, medications, and other clinical data
- AI-powered cohort discovery and patient stratification
- Patient journey, treatment pattern, and disease progression analysis
- Protocol feasibility and site-selection support
- Study and enrollment strategy optimization through a unified platform
AI-Supported Recruitment and Participant Engagement
M3 Wake Research translate patient identification into active recruitment through AI-supported outreach, automated pre-screening, intelligent study matching, and timely escalation to experienced recruitment teams.
By combining automated workflows with responsive human support, we can engage prospective participants sooner, reduce lead drop-off, and create a more efficient path from initial interest to site-level follow-up.
Key capabilities include:
- Immediate outreach to prospective participants
- AI-powered SMS and voice-based engagement
- Automated pre-screening and preliminary eligibility assessment
- Intelligent patient-to-study matching
- Seamless escalation to experienced recruitment teams
- Continuous workflow optimization based on recruitment performance
From Patient Intelligence to Enrollment Execution
With AI-powered patient matching and recruitment, M3 Wake Research connects outpatient data, protocol-aligned patient identification, timely outreach, and efficient pre-screening with responsive human engagement.
By integrating these technologies with experienced recruitment teams, embedded Patient Enrollment Coordinators, direct-access partnerships, and established patient relationships, M3 Wake Research provides sponsors and CROs with a more connected path from feasibility and patient identification to screening and enrollment.
Participant Representation Across Our Network
Our research sites serve communities across nine states, providing access to participants across different ages, racial and ethnic backgrounds, and life experiences. This reach helps sponsors and CROs evaluate study opportunities across populations that more closely reflect the patients affected by the conditions being studied.
Participant Population at a Glance
- 71% female
- 29% male
- 58.4% ages 36 to 65
- 21.8% ages 66 and older
- 18.5% ages 19 to 35
- 1.3% ages 18 and younger
- 22% Hispanic or Latino
- 24% Black or African American
- 73% White
- 3% other reported racial backgrounds
Responsive Participant Engagement
Patient Access Supported by Responsive Human Engagement
Access to potential participants is only the beginning. Our centralized recruitment team works alongside direct-access partners and Patient Enrollment Coordinators embedded within our sites to help move potentially qualified individuals from initial outreach through screening and study participation.
This coordinated model supports:
- Partner- and physician-supported outreach
- Study-specific recruitment strategies
- Digital, print, community, and referral-based outreach
- Custom landing pages and digital pre-screening tools
- Multilingual and culturally responsive communication
- Lead follow-up and screening coordination
- Participant education
- Retention-focused engagement throughout the study
- Community and patient advocacy outreach
Recruitment performance is monitored from initial inquiry through screening, randomization, and study completion. This allows our teams to refine outreach based on actual conversion and enrollment performance.
Rapid, Coordinated Study Activation
Centralized Start-Up With Local Accountability
Our centralized start-up teams coordinate feasibility, contracts, budgets, regulatory submissions, recruitment preparation, and site readiness across the network.
Our start-up model includes:
- Feasibility response within approximately one to three days
- Careful matching of site and investigator experience to each protocol
- Centralized contract and budget negotiation
- Central IRB coordination
- One regulatory contact across participating sites
- Early patient population and recruitment planning
- Study-specific activation tracking
- Clear communication across selected locations
Our standard goal is contract and budget execution within approximately three to four weeks of receiving the initial CTA and budget.
Research-Ready Physician Partnerships
Engaged Investigators With Established Patient Relationships
Our 70+ investigators are selected for more than therapeutic credentials. We prioritize investigators who are clinically active, engaged in their communities, committed to participant care, and prepared to provide meaningful study oversight.
Investigator engagement is supported through:
- Defined oversight expectations
- Role and responsibility guidance
- Site mentorship and onboarding
- Peer-to-peer collaboration
- Monthly investigator forums
- Ongoing performance feedback
- Investigator committee participation
- Thought leadership opportunities
- Clear performance benchmarks
Many investigators maintain active clinical practices or affiliations with specialty practices, hospitals, healthcare systems, and academic institutions. These relationships expand therapeutic expertise, referral reach, and access to clinically relevant patient populations.
Quality Built Into Study Execution
Proactive Oversight From Start-Up Through Closeout
Quality should not begin when an audit or monitoring visit is scheduled. At M3 Wake Research, quality oversight begins before participant enrollment and continues throughout the study. Our proactive model helps identify risks earlier, support accurate documentation, protect participants, and maintain sponsor confidence.
Why Sponsors Choose Us
Feasibility and Site Selection
Audit & Inspection Checklists are provided and reviewed with site staff to stay organized and ready.
Source Review Prior to Implementation
Quality reviews source creation prior to implementation to ensure accuracy and compliance from the start.
Proactive Quality Review
Review of the first 5 screened and first 5 randomized participants, or more during high-enrollment periods.
100% review of all informed consent forms.
IRB Reportable Events Review
Quality reviews IRB Reportable events such as deviations and SAE’s prior to submission to ensure timely, accurate, and compliant reporting and trend identification.
Trend Analysis & Risk Reduction
Quality identifies network-level trends and opportunities across studies to reduce risk and drive continuous improvement.
Minimum 50% chart review using a risk-based approach.
CAPA Support,
Training & Education
Quality supports CAPA development, implementation, and effectiveness checks.
Quality conducts targeted trainings during QC visits.
Continuous Quality Oversight
Quality performs IMV follow up reviews, provides feedback, and collaborates closely with sites to support trial success.
Demonstrated Inspection Readiness
6 Sponsor Audits Successfully Completed
- Proactive quality oversight identifies and addresses opportunities before sponsor review.
- Minor observations only, reinforcing our commitment to continuous improvement and operational excellence.
- Audits are viewed as valuable opportunities to strengthen collaboration, transparency, and site readiness.
1 FDA Inspection – No Action Indicated (NAI)
- Highest FDA inspection outcome.
- Minor observations only, reinforcing our commitment to continuous improvement and operational excellence.
Local Expertise. National Reach.
M3 Wake Research combines the consistency of a centralized operating model with the clinical expertise, patient access, and community relationships of 16+ wholly owned research sites across nine states.
One Network. Distinct Local Strengths.
Each location offers a distinct combination of:
- Experienced investigators with active clinical practices
- Access to established local patient populations
- Physician and community referral relationships
- Therapeutic and study-phase experience
- Diverse patient populations
- Therapeutic and study-phase experience
- Multilingual and culturally responsive teams
- Site-specific clinical and procedural capabilities
- Demonstrated enrollment and retention performance
Our centralized team helps sponsors and CROs identify the locations best aligned with each protocol while supporting consistent start-up, recruitment, quality, and study execution across participating sites.
Our Nationwide Research Clinics
Explore our network to identify research locations aligned with your protocol, therapeutic area, target patient population, and geographic requirements.
Each clinic page highlights the location’s investigator expertise, patient access, research experience, and site-specific capabilities. Select a clinic below to learn more:
A More Connected Path From Feasibility to Enrollment
M3 Wake Research brings direct patient access, responsive recruitment, operational speed, quality oversight, and trusted physician relationships together within one coordinated research network.
Whether you need a single specialized site, a multisite enrollment strategy, or additional support for a challenging study, our business development and clinical teams are ready to evaluate the opportunity.
News & Updates
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