Therapeutic Focus
Our trial portfolio is concentrated in areas of high unmet need where biomarker-driven design, novel agents, and combination approaches are actively redefining standard of care. We do not conduct trials outside oncology and haematology.
Haematological Malignancies
CLL, SLL, AML, DLBCL, and indolent lymphoma — novel agents, drug combinations, and supportive care strategies.
Precision & Genomic Oncology
Biomarker-enriched and basket trial designs; molecular profiling, ctDNA monitoring, companion diagnostic integration.
Immuno-Oncology
Checkpoint inhibitors, CAR-T adjacent approaches, bispecific antibodies, and combination immunotherapy regimens across solid tumours.
Solid Tumours — GI & Lung Focus
Pancreatic adenocarcinoma, colorectal, gastric, NSCLC — including RAS-mutant and KRAS-targeted programme experience.
Cancer Risk & Metabolic Factors
Obesity-related cancer risk, metabolic syndrome co-morbidity, and prevention-adjacent studies in diverse populations.
Multi-Cancer Early Detection (MCED)
Clinical utility and real-world implementation studies for liquid biopsy MCED tests; ctDNA and epigenomic signal validation.
Trial Phase Coverage
We design and operate trials across the full development continuum. Each phase brings distinct operational requirements — we resource accordingly rather than applying a one-size model.
| Capability | Phase I | Phase II / III |
|---|---|---|
| Study designs | FIH, dose escalation (3+3, BOIN, mTPI), MTD/RP2D determination | Randomised controlled, adaptive, basket, umbrella, platform |
| Patient volumes | 15–80 participants (typical) | 80–600+ participants; multi-site scale-out |
| Primary endpoints | Safety, tolerability, PK/PD, dose-limiting toxicities | OS, PFS, ORR, DOR, EFS; PRO instruments |
| Biomarker integration | PK sampling, exploratory biomarkers, archival tissue | Prospective companion diagnostic, ctDNA, MRD monitoring |
| Regulatory submissions | IND filing support, DSUR, SAE reporting | End-of-phase meetings, NDA/BLA module contributions, REMS support |
| Data management | EDC build, CRF design, DMP, data reconciliation | EDC, central lab integration, PRO platform, CDISC SDTM/ADaM outputs |
Geographic Coverage
Primary Site — Oak Brook, Illinois
Our principal research site is located at 1415 W 22nd Street, Tower Floor, Oak Brook, IL 60523 — within the Chicago metropolitan area, providing access to a diverse, urban–suburban patient population with high rates of clinical trial awareness.
Satellite & Partner Site Network
For Phase II and III programmes requiring multi-site enrolment, we activate through a partner network of community oncology practices and academic affiliate sites across the US Midwest and beyond. Site selection follows the sponsor's geographic enrolment strategy and feasibility criteria.
- Primary hub: Oak Brook, IL (all phases)
- Affiliate network: Illinois, Indiana, Wisconsin (Phases II–III)
- National site expansion: available on a trial-specific basis via sub-investigator agreements
- International: feasibility support for ex-US sites available in partnership with established international CRO partners
Activation Timeline
Standard site activation from sponsor enquiry to first patient screened: 8–12 weeks for studies using standard protocols with prior IRB experience. Accelerated timelines available for oncology-specific fast-track designations.
Site Network Model
We operate a hub-and-spoke model: the Oak Brook site functions as the principal site with full operational infrastructure; satellite sites are initiated under a sub-investigator agreement with central oversight retained by our Principal Investigator team.
- All sites operate under a single IRB (central or local as required by sponsor)
- Centralised monitoring and data management from Oak Brook
- Site initiation visits (SIV) conducted in person by our clinical operations team
- Ongoing site management: remote monitoring, on-site co-monitoring, and directed audits
- Investigator meeting co-ordination and ongoing training via our education platform
Biospecimen Capabilities
Biospecimen collection and management is conducted as an integrated part of trial operations — not outsourced — ensuring chain-of-custody integrity and protocol compliance at every handling step.
Collection Types Supported
- Whole blood (EDTA, serum, plasma, PAXgene)
- cfDNA / ctDNA (liquid biopsy — Streck BCT tubes, ultra-low passage)
- PBMC isolation and cryopreservation
- Formalin-fixed paraffin-embedded (FFPE) archival tissue retrieval
- Fresh-frozen core biopsies and fine-needle aspirates
- Urine, saliva, and stool (protocol-specific)
Processing & Storage Infrastructure
- Ultra-low temperature: –80°C capacity (solar-backed, grid-independent cold chain)
- Standard cold: –20°C and 4°C backup capacity
- Nitrogen vapour phase cryopreservation for long-term PBMC storage
- Centrifuge, aliquoting, and barcode labelling to sponsor-specified SOPs
- Chain-of-custody documentation and temperature excursion logging
Companion Diagnostic (CDx) Integration
We have direct experience supporting CDx co-development in oncology trials — including prospective tissue collection for IVD validation studies, bridging studies, and labelling-intent biomarker programmes. Familiarity with FDA PMA and 510(k) CDx regulatory pathways.
Operational Services
We deliver the following services in-house. All functions are staffed by qualified oncology specialists and operate under our standard operating procedure (SOP) framework.
Protocol Design
Feasibility review, endpoint selection, statistical assumptions, and eligibility criteria refinement.
Regulatory Affairs
IND preparation, FDA correspondence, DSUR, SAE reporting, end-of-phase meeting support.
IRB / Ethics Co-ordination
Central and local IRB submission, amendment management, continuing review.
Site Management
SIV, site qualification, ongoing monitoring (on-site and remote), SDV, and audit readiness.
Data Management
EDC build and validation, CRF design, DMP, query management, CDISC SDTM/ADaM outputs.
Biostatistics
SAP development, sample size calculations, interim analysis planning, statistical reporting.
Safety Monitoring
DSMB charter support, pharmacovigilance, safety narrative writing, MedDRA coding.
Medical Writing
Clinical study reports (ICH E3), investigator brochures, informed consent documents, publications.
Patient Recruitment
Eligibility screening, referral pathway management, retention strategies, and diversity enrolment planning.
Quality Assurance & Regulatory Compliance
All operations are conducted under a written quality management system. We maintain audit-ready documentation at all times and support sponsor and regulatory agency inspections.
- Full trial master file (eTMF) maintained per ICH E6(R3) and sponsor requirements
- SOPs reviewed and updated annually; version-controlled and staff-accessible
- Pre-inspection audits available on sponsor request
- Delegation log, CV, and training record maintenance for all site staff
- All protocols pre-specified with a signed, dated statistical analysis plan prior to unblinding
Technology & Systems
- CTMS: Sponsor-compatible clinical trial management system integration; experience with major CTMS platforms
- EDC: Electronic data capture build and validation; CDISC-compliant outputs
- eTMF: Electronic trial master file maintained to ICH E6(R3) standards
- ePRO/eCOA: Electronic patient-reported outcome platforms; mobile-first options available
- Randomisation & IVRS/IWRS: Third-party integration supported
- Biospecimen LIMS: Sample tracking from collection through shipment and repository storage
KCLEAGENICS MEDICAL Capability Statement
A single-page summary of our CRO capabilities, site specifications, and contact details — formatted for RFP submissions and feasibility packages.
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