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

Protocol expertise,
on demand.

Specialist oncology consulting for biopharma sponsors and CROs — from protocol feasibility and I/E translation to site readiness assessment and ongoing trial liaison. Grounded in real site operations, not theory.

🏥 Phase I–III Oncology Experience
📋 GCP / ICH E6(R3) Certified
⚖️ FDA 21 CFR Part 312 Familiar
⏱️ 5–10 Day Standard Turnaround
🔒 NDA / Confidentiality Standard

Built for teams who need a specialist, not a generalist

Oncology protocols are operationally dense — narrow eligibility windows, biomarker gating, complex dosing schedules, and sites that may have never run your tumour type before. Our consulting services are designed for sponsors and CROs that need focused, rapid-turnaround expertise grounded in how oncology sites actually operate: what questions site coordinators ask, where recruitment stalls, and how to fix it before it costs you enrolment.

Service Tiers

Four ways we can help your programme

Service 01

Protocol Feasibility Review

Rapid operational assessment of whether a protocol can realistically recruit at a given site or site network.

What you receive
  • I/E complexity scoring across all criteria
  • Local patient population alignment analysis
  • Competitive trial landscape check (ClinicalTrials.gov)
  • Realistic monthly enrolment projection with assumptions
  • Site capability gaps and recommended mitigations
  • Written feasibility memo (3–5 pages), ready for sponsor review
Pricing Fixed-fee · Quoted on scope
Turnaround 5–7 business days
Format Remote / Async
Service 02

Plain-Language I/E Translation

Transform dense eligibility criteria into patient-accessible language that improves accrual without compromising protocol integrity.

What you receive
  • Full I/E criteria rewritten at 6th–8th grade readability
  • Patient-facing eligibility summary (web and print-ready)
  • Pre-screening question set (10–15 questions) for intake forms
  • Patient FAQ draft covering common eligibility queries
  • Alignment review against original protocol language
  • Formatted for direct upload to trial listing pages
Pricing Fixed-fee · Quoted on scope
Turnaround 3–5 business days
Format Remote / Async
Service 03

Site Readiness Assessment

Structured evaluation of an investigative site's operational readiness before trial activation — reducing site-initiation delays and SSU timelines.

What you receive
  • SOP review against GCP/ICH E6(R3) requirements
  • Staff GCP training currency verification
  • Patient flow and scheduling capacity assessment
  • Regulatory binder and essential document readiness check
  • Equipment and cold-chain storage review (where applicable)
  • Gap report with prioritised remediation plan and timeline
Pricing Fixed-fee · Quoted on scope
Turnaround 7–10 business days
Format Remote assessment
Service 04

Trial Liaison & Site Selection Retainer

Ongoing independent support for CROs and sponsors identifying, evaluating, and activating oncology investigative sites across the US.

What you receive
  • Site identification and outreach for target therapeutic area
  • Feasibility questionnaire design and management
  • Site capability benchmarking against protocol requirements
  • Sponsor-ready site assessment summaries
  • Ongoing liaison between sponsor team and research sites
  • Monthly activity and pipeline report
Pricing Monthly retainer · Quoted on scope
Commitment 3-month minimum
Format Ongoing / Retainer

All project fees are confirmed after a brief scoping call. Custom engagements and multi-protocol packages available on request.

Process

From enquiry to deliverable in days, not weeks

1

Submit your project brief

Complete the enquiry form below with your protocol name, service needed, and timeline. No lengthy RFP — a paragraph describing the challenge is enough to get started.

2

30-minute scoping call

We'll confirm scope, agree deliverable format, sign an NDA if required, and provide a fixed project fee within 24 hours. No retainer required for project-based work.

3

Receive your deliverable

Work is completed to the agreed timeline — typically 3–10 business days. All documents are reviewed for accuracy and formatted for direct use by your clinical operations team.

Start with a project brief

Tell us what you're working on — protocol name, the challenge you're facing, and your timeline. We'll respond within one business day with a scoping call invitation or, for straightforward requests, a direct fee proposal.

Enquiries are treated as confidential. We routinely operate under NDA from day one of any engagement and will sign your preferred form if required.

Response commitment: All enquiries receive a substantive response within one business day (Monday–Friday, US Central time). For urgent feasibility requests or pre-submission timelines, note that in your message and we will prioritise accordingly.

Prefer a direct conversation?

keog@kclgmedical.com   |   312-225-3916

Project Enquiry

Enquiries are confidential. Contact details and project information are used solely to scope and respond to your enquiry — they are not shared with third parties. An NDA can be executed prior to any detailed disclosure. GDPR (EEA/UK): you may request access, correction, or deletion of your data at any time by emailing keog@kclgmedical.com. See our Privacy Policy.

Credentials & Standards

All consulting work is performed to GCP/ICH E6(R3) standards with reference to applicable FDA regulations.

GCP / ICH E6(R3) FDA 21 CFR Part 312 FDA 21 CFR Part 50 & 56 CDISC SDTM / ADaM Familiar HIPAA Compliant Operations Phase I – III Oncology Haematology & Solid Tumours ClinicalTrials.gov Registered