KCLEAGENICS MEDICAL INC. — Capability Statement

KCLG Medical is a specialist oncology contract research organisation (CRO) providing pre-screened patient access, GCP-compliant study execution, and CRA site intelligence for Phase I–III oncology sponsors.

Our patient navigation platform attracts active oncology patients seeking clinical trials. Navigators pre-qualify patients against sponsor eligibility criteria before referral — reducing screen failure rates and accelerating first patient in. We operate as a full CRO partner, a patient recruitment supplement, or on individual service lines.

Platform at a Glance

Patient enquiries/year2,800+

Tumour types covered40+

Trial executionPhase I–III

Site audit turnaround< 15 days

Compliance standardGCP/ICH E6(R3)

Core Services

Pre-Screened Patient Recruitment

Protocol-specific patient matching. Navigators confirm diagnosis, line of therapy, and geographic availability before site referral.

Study Startup & Site Activation

Regulatory package prep, site qualification, IRB submission coordination, and startup project management.

CRA Monitoring & Site Management

Remote and on-site monitoring, query management, protocol deviation review, and enrolment reporting to ICH E6(R3).

CRA Site Feasibility Audit

Independent 15-day remote audit: staffing, SOPs, regulatory binder, source documents, facility, IRB readiness. Full report + CAP template.

Feasibility Intelligence Reports

Custom patient demand analysis, site performance benchmarks, and enrolment velocity projections for your protocol's criteria.

Sponsor Visibility & Media

Newsletter sponsorship (1,400+ clinical ops subscribers), featured protocol listings, and sponsored feasibility reports.

What Makes KCLG Different

Pre-screening, not raw referrals Patients are checked against key eligibility criteria by our navigators before reaching your site coordinator — reducing wasted screen visits.

Community site intelligence We audit community oncology practices before you spend time on site qualification — so you know site readiness before committing budget.

Oncology-only focus 40+ tumour types, ADC / bispecific / CAR-T / checkpoint inhibitor platform experience. No therapeutic area generalism.

Fixed-fee, scoped proposals All services are quoted on scope — no open-ended billing. You receive a written feasibility note and proposal before committing.

How We Work Together

Discovery Call

Review protocol, eligibility, and timeline. Assess fit with patient platform and site network within 48 hours.

Feasibility & Proposal

Written patient volume estimate, site recommendations, timeline, and fixed-fee proposal.

Study Startup

Regulatory package prep, site qualification, IRB submission support, delegation log — GCP/ICH E6(R3).

Enrolment & Monitoring

Pre-screened patient referrals, site monitoring, query resolution, and regular sponsor reporting.

Compliance & Credentials

✅ GCP / ICH E6(R3) Certified 🏛 FDA 21 CFR Parts 11, 50, 56, 312 📋 ClinicalTrials.gov Registered 🔒 HIPAA-Aligned Patient Data Handling 📄 IRB Submission Experience 🧪 Phase I–III Monitoring Experience

Experienced in ADC, bispecific antibody, CAR-T, and checkpoint inhibitor programmes. Community and academic oncology site networks.

Ready to discuss your Phase I/II enrolment challenge? Send us your protocol synopsis — we'll respond within one business day with a preliminary feasibility note.

Request a Discovery Call keog@kclgmedical.com 312-225-3916