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For Sponsors & CROs

Site Performance & Clinical Outcomes

Every metric a sponsor needs to evaluate KCLG Medical as a clinical trial site — screen failure rates, recruitment velocity, retention, protocol deviation record, biospecimen performance, and audit history. No marketing language. Numbers only.

Download Capability Statement ↓ Request a Site Qualification Visit
ICH GCP E6(R2) Certified FDA 21 CFR Compliant ClinicalTrials.gov Registered 0 FDA Critical Findings
Screen Failure Rate 18% Industry average: 35–55% in oncology ↓ 37% below sector average
Recruitment Velocity 2.3pts/mo Per active oncology trial protocol ↑ Ahead of contract timelines
Patient Retention 94% Completion through primary endpoint ↑ Above 85% benchmark
Protocol Deviations 0.4% Major deviations per 1,000 patient visits ↓ Well below 2% threshold
Performance Detail

Metrics That Matter to Sponsors

Benchmarked against published oncology site performance data from SCRS, ACRP, and TransCelerate industry surveys.

18%
Screen Failure Rate

Our patient education programme and pre-screening consultation model means fewer ineligible patients reach formal screening. Pre-educated patients understand eligibility criteria before their first visit.

KCLGIndustry avg (35–55%)
Why it matters: Lower screen failure = lower cost per randomised patient and faster database lock.
2.3
Patients / Month Recruited

Measured per active oncology protocol. Driven by our proprietary patient registry, educational blog attracting pre-qualified patients, and clinical network referral relationships with specialist centres.

KCLGBenchmark (0.8–1.5/mo)
Why it matters: Recruitment velocity directly determines whether your trial hits its primary completion date.
94%
Patient Retention Rate

Through primary endpoint completion. Our patient liaison programme, plain-language visit reminders, and flexible scheduling reduce dropout. Retention is tracked visit-by-visit with proactive outreach at first missed contact.

KCLGBenchmark (~85%)
Why it matters: Dropout after randomisation compromises primary analysis and requires protocol amendments.
0.4%
Major Protocol Deviation Rate

Per 1,000 patient visits across all active protocols. Protocol deviations are tracked in real time and root-cause analysed within 48 hours. We operate a no-blame deviation reporting culture with mandatory CAPA implementation.

KCLGThreshold (2%)
Why it matters: Major deviations can disqualify patient data and trigger FDA observations at inspection.
98%
Biospecimen Yield Rate

Acceptable specimens meeting protocol-specified quality parameters. Our dedicated cold chain infrastructure, trained phlebotomy staff, and same-day processing protocol consistently exceed central lab acceptance criteria.

KCLGCentral lab minimum (90%)
Why it matters: Failed specimens require repeat sampling, distressing patients and delaying laboratory analysis timelines.
100%
On-Time Data Entry

eCRF entries completed within protocol-required timeframe across all trials. Real-time query resolution with a median query close time of 2.1 business days. Our data management team operates within the site, not offsite.

KCLGBenchmark (≥95%)
Why it matters: Late data entry generates queries, delays interim analyses, and creates regulatory risk at inspection.
Trial Portfolio

Active & Completed Studies

Our portfolio spans Phase I–II oncology and haematology trials across multiple therapeutic modalities.

Protocol ID Indication Phase Intervention Type Status n (Site)
KCLG-HAEM-01 CLL / SLL — Relapsed/Refractory Phase II Targeted therapy combination Recruiting 18 / 60
KCLG-ONC-02 Diffuse Large B-Cell Lymphoma Phase I/II CAR-T cell therapy Active — Follow-up 12 / 12
KCLG-ONC-03 Multiple Myeloma — 4th Line+ Phase II Bispecific antibody Recruiting 7 / 30
KCLG-MET-01 Metabolic Syndrome — CLL risk Phase II Lifestyle + pharmacological Active — Ongoing 22 / 40
KCLG-ONC-04 HER2-Low Breast Cancer Phase II Antibody-Drug Conjugate Opening Q4 2026 — / 45

All trials registered on ClinicalTrials.gov. Protocol IDs are internal reference codes. Contact us for NCT numbers and full eligibility criteria.

Our People

Site Team Capabilities

A dedicated, protocol-trained team. No shared staff across unrelated departments.

🩺 Principal Investigators Board-certified in medical oncology and haematology. Average 12 years clinical trial experience.
📋 Clinical Research Coordinators Dedicated CRC per active protocol. ACRP CCRC certified. Trained in oncology-specific eCRF systems.
🔬 Biospecimen Processing In-house lab for PBMC isolation, serum separation, and biomarker sample prep. IATA-certified cold chain shipping.
📊 Data Management Onsite data entry with Medidata Rave and REDCap experience. Median query close: 2.1 business days.
🤝 Patient Liaison Dedicated patient support coordinator. Provides transport coordination, visit reminders, and consent support in plain language.
⚖️ Regulatory Affairs In-house regulatory coordinator for IND, IRB submissions, protocol amendments, and safety reporting. Average 9-day IRB turnaround.
🧬 Pharmacogenomics Experience with biomarker-stratified protocols including FISH, IHC, NGS-based patient selection.
📚 Medical Writing In-house support for clinical study reports, interim analyses, and regulatory submission documents.
Site Infrastructure

Technology & Facilities

Clinical Facilities

✓3 dedicated oncology infusion chairs
✓Negative pressure isolation room for immunocompromised patients
✓Crash cart and CRS monitoring equipment on-site
✓On-call physician protocol for adverse events
✓Accessible facility — ADA compliant, free parking

Laboratory & Specimens

✓PBMC isolation capability (Ficoll density gradient)
✓-80°C ultra-low temperature freezer storage
✓Liquid nitrogen vapour-phase backup storage
✓Automated temperature monitoring with 24/7 alerts
✓IATA P650 certified cold chain shipping
✓Same-day processing of time-critical specimens

Data & Technology

✓Medidata Rave, Veeva Vault, REDCap
✓21 CFR Part 11 compliant electronic records
✓HIPAA-compliant data infrastructure
✓Remote eSource capability for decentralised elements
✓IRB portal integration (WCG, Advarra)
✓eTMF with sponsor read access on request
Regulatory Record

Audit & Inspection History

A clean regulatory record is the most credible signal of site quality. Ours is available for sponsor review under NDA.

2026
Sponsor QA Audit — Phase II Oncology Protocol
Full system audit covering TMF, IB access, consent documentation, specimen chain of custody, and eCRF compliance.
No findings · Audit closed
2025
IRB Continuing Review — KCLG-HAEM-01
Annual safety and compliance review including adverse event log, protocol deviation register, and consent re-review for long-term participants.
Approved — No modifications required
2025
GCP Re-Certification Audit
Full-site GCP audit supporting renewed certification. Staff training records, SOP currency, delegation logs, and equipment calibration records reviewed.
GCP Certified — Full compliance
2024
FDA 21 CFR Part 11 Compliance Review
Electronic records and e-signature systems reviewed for Part 11 compliance. System access logs, audit trails, and validation documentation assessed.
Compliant — 0 critical findings

For Sponsors: What We Provide

On request under a current NDA or CDA, KCLG Medical provides:

✓Full audit reports from prior sponsor QA audits
✓Site qualification questionnaire (SQQ) responses
✓Staff CV and training record package
✓Current SOP index
✓Recruitment feasibility data for your indication
✓Financial disclosure documentation (FDA Form 3454/3455)
✓Laboratory certification (CLIA, CAP where applicable)
Download Capability Statement ↓ Request Site Qualification Package