Specialist Oncology CRO · Phase I–III Trial Execution  |  312-225-3916  |  keog@kclgmedical.com
GCP Certified FDA Compliant ClinicalTrials.gov Registered
Sponsor Feasibility Directory

Site capabilities,
searchable by your protocol.

Assess KCLEAGENICS MEDICAL's oncology site against your open protocol — by tumour type, trial phase, required procedures, and regulatory standing. Submit a feasibility questionnaire and receive a formal site response within 5 business days.

Submit Feasibility Questionnaire Browse Tumour Capabilities
Phase I–III
Trial Phases
6+
Oncology Subspecialties
5 days
Feasibility Response Time
FDA / ICH
Regulatory Standing
GCP E6(R3)
Inspection Standard
Tumour Type Directory

Oncology subspecialties we operate in

We maintain active experience across the tumour types below. "Active" indicates currently running or recently closed trials in that indication; "Capable" indicates site infrastructure and experience sufficient to support protocol activation.

Thoracic Oncology

Active

NSCLC (adenocarcinoma, squamous, large cell), SCLC, mesothelioma, thymic tumours

KRAS G12C EGFR ALK/ROS1 PD-L1 Phase I–III

Haematologic Malignancies

Active

DLBCL, CLL/SLL, AML, ALL, MDS, multiple myeloma, Hodgkin and non-Hodgkin lymphoma

BTK inhibitors CAR-T adjacent Bone marrow Phase I–II

Gastrointestinal Oncology

Active

Colorectal, pancreatic adenocarcinoma, gastric/GEJ, HCC, cholangiocarcinoma, GIST

KRAS/NRAS/BRAF MSI-H HER2 FGFR2 Phase II–III

Breast & Gynaecologic Oncology

Capable

HR+/HER2−, HER2+, TNBC, ovarian (BRCA), endometrial, cervical

BRCA1/2 HER2 PD-L1 CDK4/6 Phase II–III

Genitourinary Oncology

Capable

Prostate (mCRPC, mCSPC), urothelial/bladder, renal cell carcinoma

PSMA AR signalling PD-1/L1 VEGF Phase I–III

Rare & Solid Tumours

Capable

Sarcoma, thyroid, neuroendocrine tumours, melanoma, HNSCC, tumour-agnostic (MSI-H, TMB-H, NTRK)

NTRK fusion TMB-H MSI-H Tumour-agnostic
Phase Capability

What we can run — by trial phase and design

Site experience and infrastructure mapped against trial phase, design type, and required procedures. Use this table to assess fit before submitting a formal feasibility questionnaire.

Trial Phase / Design Site Experience First-in-Human DLT Monitoring PK Sampling REMS Protocols Biospecimen Collection
Phase I Dose escalation ✓ Active Enquire ✓ Yes ✓ Yes ✓ Yes ✓ Yes
Phase I/II Expansion cohort ✓ Active – ✓ Yes ✓ Yes Selected ✓ Yes
Phase II Single-arm / randomised ✓ Active – If required If required ✓ Yes ✓ Yes
Phase III Randomised controlled ✓ Active – – If required ✓ Yes ✓ Yes
Biomarker Biomarker / translational ✓ Active – – – – ✓ Full capability
Registry Observational / registry ✓ Active – – – – Selected
Site Infrastructure

Facilities, equipment, and operational capability

Infrastructure detail commonly requested during sponsor feasibility assessment and site qualification.

🧪 Laboratory & Sample Processing

  • Dedicated clinical research laboratory space
  • Centrifuge, aliquoting, and cold-chain processing capability
  • Ultra-low temperature storage (−80°C)
  • Tumour tissue and FFPE block collection and archival
  • Liquid biopsy (ctDNA) sample processing
  • PBMC isolation and biospecimen preparation per protocol SOPs
  • Established logistics for central lab and sponsor biorepository shipment

👨‍💼 Clinical & Operational Staff

  • GCP-trained principal investigator and sub-investigator(s)
  • Dedicated clinical research coordinators (CRCs)
  • Regulatory affairs and IRB submission support
  • Data entry staff trained in EDC systems (Medidata Rave, Veeva Vault)
  • Pharmacy liaison and IMP accountability documentation
  • Patient navigation and clinical trial consent team

💻 Data & Systems

  • 21 CFR Part 11-compliant EDC capabilities
  • Secure eTMF document management
  • Site Master File (SMF) maintained and audit-ready
  • EHR integration capability for source data
  • Remote monitoring access configuration
  • eConsent-compatible patient intake workflow

📍 Clinical Procedures

  • IV administration, infusion monitoring, and adverse event management
  • Oral and SC investigational product administration
  • Serial tumour measurement and RECIST/iRECIST assessments
  • Bone marrow biopsy coordination (haematology protocols)
  • ECG, vital signs, and safety monitoring per protocol schedule
  • Imaging coordination (CT/PET — third-party radiology partners)
Regulatory Standing

Compliance credentials and audit readiness

📋

GCP / ICH E6(R3)

All site staff trained to current GCP standards. Investigator and CRC training certificates maintained and current.

Current
🏛️

FDA 21 CFR Part 312

Site operating procedures aligned with FDA IND requirements. Audit-ready documentation maintained in real time.

Compliant
📁

ClinicalTrials.gov Registration

All active trials registered per FDAAA 801 requirements. Results reporting compliant with NIH mandatory disclosure timelines.

Registered
🔐

HIPAA & Data Security

Patient data handled under HIPAA-compliant protocols. BAA executed with sponsors and data processors. Secure data transfer procedures in place.

Compliant
⚖️

IRB / IEC Oversight

Active relationship with accredited IRB. Protocol amendments and safety reporting processed within required timelines.

Active
🧾

Financial Disclosure

Investigator financial disclosure certifications maintained. COI review and disclosure process documented per 21 CFR Part 54.

Maintained

Submit a Feasibility Questionnaire

Use this form to provide the key details of your protocol. We'll review your submission against our site capabilities — tumour type, phase, required procedures, staff, and regulatory fit — and return a formal feasibility response within 5 business days.

For complex protocols or multi-site discussions, we're happy to schedule a feasibility call first — note this preference in the form.

Feasibility process & timelines

Initial response / acknowledgement 1 business day
Formal feasibility response 5 business days
Site qualification package (if requested) 7–10 business days
Feasibility call (optional) Arranged within 3 days

Protocol Feasibility Request

Formal response within 5 business days. Protocol and contact details are used solely to prepare and deliver a feasibility response — they are not shared with third parties. GDPR: EEA/UK contacts may request data access or deletion by emailing keog@kclgmedical.com. See our Privacy Policy.