AI Automation for CROs & Clinical Research Organizations
Clinical research organizations juggle multiple active studies, dozens of sites, and relentless sponsor demands. We automate the workflows that slow trials down — lab data integration, multi-site coordination, regulatory submissions, and sponsor reporting.
Book Free AssessmentThe Challenges CROs Face Today
Clinical research is one of the most data-intensive, multi-stakeholder environments in healthcare. Manual workflows are the primary bottleneck.
Protocol Deviations Delay Trials
35% of trials have major deviationsProtocol deviations — missed visits, incorrect dosing, wrong lab panels — can invalidate data, trigger FDA queries, and delay timelines by months. Most deviations stem from manual workflow coordination across sites, not clinical errors.
Manual Data Collection Creates Errors
10-15% query rate on manually entered dataClinical research associates spend hours entering lab results, adverse events, and endpoint data into EDC systems. Manual transcription from lab reports, paper CRFs, and site databases generates queries that delay database lock.
Regulatory Submissions Take Months
6-12 months for NDA/BLA submissionsCompiling submission-ready data packages from multiple sites, labs, and systems is an enormous manual effort. Document formatting, cross-referencing, and quality review consume thousands of person-hours per submission.
Multi-Site Coordination Is a Full-Time Job
Average trial spans 40+ sitesCoordinating lab kits, sample shipments, result delivery, and protocol amendments across dozens of sites globally requires constant communication. When one site deviates from the protocol, the ripple effect impacts the entire trial.
Sponsor Reporting Demands Keep Growing
70+ sponsor reports per studySponsors demand real-time visibility into enrollment, lab results, adverse events, and site performance. CROs scramble to compile reports from disparate systems — often delivering stale data because the aggregation process is manual.
What We Automate for CROs
We focus on the workflows that directly impact trial timelines, data quality, and sponsor satisfaction.
Lab Operations
Automate central lab workflows — sample receipt, testing, result validation, and delivery to EDC systems. Full audit trail for regulatory inspection.
See workflowsAnalytics & Reporting
Real-time dashboards for enrollment tracking, lab result turnaround, query rates, and site performance metrics. Automated sponsor reports.
See workflowsTeam Collaboration
Automate cross-site communication, protocol amendment distribution, and deviation tracking. Keep all sites aligned without manual coordination.
See workflowsLab Systems Modernization
Integrate LIMS with EDC, CTMS, and IRT systems. Modernize central lab infrastructure without disrupting active studies.
See workflowsWhich Type of Organization Are You?
Systems We Integrate With
We connect your LIMS to EDC, CTMS, IRT, and eTMF platforms — building a validated data pipeline across your clinical infrastructure.
Medidata Rave
EDC
Oracle Health Sciences
EDC/CTMS
Veeva Vault
eTMF/QMS
REDCap
EDC
LabVantage
LIMS
LabWare
LIMS
STARLIMS
LIMS
Medidata Balance (IRT)
Randomization
Results CROs See
60-80%
Reduction in data query rates
30%
Faster regulatory submissions
40+
Sites coordinated per study
How It Works
Free CRO Assessment
We audit your lab workflows, data flows between LIMS and EDC, multi-site coordination processes, and reporting pipelines.
Free
AI Roadmap + Implementation
AI Roadmap ($1,999) with $50K savings guarantee. Build phase includes FDA Part 11 validation and study-specific configuration.
$1,999 roadmap
Managed Operation
We monitor, maintain, and adapt your automation as new studies launch and existing studies evolve. New study setup takes days, not weeks.
$2K-$5K/mo
Frequently Asked Questions
Ready to Accelerate Your Trials?
We start every engagement with a free assessment. We will map your current workflows, identify where manual processes are slowing your trials, and show you exactly which automations deliver the fastest ROI.
- Free CRO workflow assessment — no commitment
- AI Roadmap with $50K savings guarantee
- FDA Part 11 compliant with GAMP 5 validation
- Integrates with Medidata, Oracle, Veeva, REDCap