KCO Consulting LLC
Services Contact Privacy Terms

KCO Consulting

Biometrics That Move Your Trials Forward.

Gap-filling expertise or full project ownership — Phase I through submission.

Explore Services Contact us
Trial Readout Model Live
Design
0%
Data
0%
Stats
0%
Tables
0%
Phase I-IV Design, analysis, programming, oversight
SDTM / ADaM

Full-spectrum support

From focused expertise to complete project ownership.

We work with sponsors and clinical teams that need clear statistical thinking, dependable delivery, and practical biometrics leadership across the development journey.

01Clinical trial design and endpoint strategy
02Analysis, programming, and submission packages
03Vendor oversight and process improvement

Services

We offer a variety of services to support you along your journey.

Flexible consulting and execution capacity for sponsors, biotech companies, CROs, and clinical development organizations.

Biostatistical Consulting

Biostatistical support for clinical trial design, endpoint development and adaptive design planning, simulation and implementation.

Biostatistical Consulting

  • Protocol design and endpoint strategy that regulators love
  • Adaptive design to de-risk decisions early
  • Sample-size optimization that routinely cuts timelines by weeks
Contact us for this service

Biostatistics

Biostatistics services for clinical trial protocol development, statistical analysis and integrated analysis of safety and efficacy.

Biostatistics

  • Full statistical analysis plans (SAP) and interim analyses
  • Integrated summaries of safety and efficacy (ISS/ISE)
  • Clear, audit-ready documentation for FDA/EMA submissions
Contact us for this service

Statistical Programming

Statistical analysis of clinical trial data and creation of submission-ready dataset packages for SDTMs and ADaMs.

Statistical Programming

  • Production-ready SDTM and ADaM datasets (CDISC compliant)
  • TLFs, safety and efficacy tables, listings and figures
  • Automated validation and quality control pipelines
Contact us for this service

Biometrics Oversight

Documented oversight of outsourced Data Management, Biostatistics and Statistical Programming activities on behalf of sponsors.

Biometrics Oversight

  • Independent vendor oversight and CRO performance reviews
  • Risk-based monitoring of data management and programming deliverables
  • Gap analysis and remediation of existing biometrics processes
Contact us for this service

Biometrics Processes

Consulting for process improvement and development of Biometrics standard operating procedures in alignment with regulatory expectations.

Biometrics Processes

  • Development of SOPs aligned with ICH E9(R1) and FDA guidance
  • Process mapping and automation opportunity identification
  • Training programs for internal biometrics teams
Contact us for this service

Adaptive Design Planning

Simulation strategy and implementation support for efficient clinical programs where design choices need rigorous quantitative evaluation.

Adaptive Design Planning

  • Simulation frameworks for seamless Phase II/III designs
  • Interim decision rules and futility/success criteria
  • Quantitative evaluation of multiple design scenarios
Contact us for this service

Integrated Analyses

Planning and delivery support for integrated summaries of safety and efficacy, including analysis strategy and documentation.

Integrated Analyses

  • Meta-analyses and pooled safety/efficacy summaries
  • Benefit-risk assessments and exploratory analyses
  • Regulatory-ready ISE/ISS documentation packages
Contact us for this service

Submission Packages

Creation and quality-focused review of submission-ready dataset packages, statistical outputs, and supporting deliverables.

Submission Packages

  • End-to-end CSR statistical sections and appendices
  • eCTD-ready dataset packages with define.xml
Contact us for this service

Contact

We are here to help.

Please send us an email with your request and we will contact you as soon as possible.

contact@kco-consulting.com

Legal

Privacy Policy

Effective date: April 30, 2026

Overview

This website is intended for companies and business representatives only. We do not use cookies, analytics pixels, advertising trackers, or contact forms on this website.

We do not collect personal information through this website except for information you choose to provide when you contact us by email or another direct means.

Information You Provide

If you contact us, we may receive your name, company name, email address, phone number, role, message contents, and any other information you decide to include. We use that information to respond to your request, evaluate a potential business relationship, provide requested services, maintain business records, and protect our legal rights.

Hosting And Security Logs

Our website is hosted by Fastmail. Fastmail states that website owners can access limited visitor information for the previous two weeks, including the date and time of access and the browser or user-agent string. Fastmail also states that it does not set additional cookies for customer-hosted websites.

Fastmail may process additional technical information as part of providing and securing its services, potentially including information such as IP address, browser type, and related service-use data, as described in Fastmail's privacy materials.

We do not separately store hosting logs outside Fastmail's systems except where reasonably necessary to investigate, document, or respond to a security incident, abuse, attempted attack, legal request, or operational problem.

For more information, see Fastmail's website hosting documentation and Privacy Policy.

Cookies, Analytics, And Tracking

We do not set cookies and do not use browser storage to remember visitors. The confirmation notice on this website is intentionally shown without saving a cookie or similar identifier.

We do not track users over time or across third-party websites, and this website does not respond differently to browser Do Not Track signals because no tracking is performed by us on the site.

Sharing Information

We do not sell personal information. We may share information you provide only with service providers, professional advisers, counterparties involved in a requested business relationship, or authorities when required or permitted by law.

California Privacy Notice

For California residents, the categories of personal information we may receive directly from you are identifiers, professional or employment-related information, commercial information related to your inquiry, and the contents of your communications. We use this information for the business purposes described above.

We do not knowingly collect personal information from children under 13, and this website is not directed to consumers or children.

Retention

We keep communications for as long as reasonably necessary for the purpose of the communication, our business records, legal compliance, dispute resolution, security, and legitimate business needs.

Contact

To ask a privacy question or request access, correction, or deletion of information you provided to us, contact us at contact@kco-consulting.com.

Changes

We may update this Privacy Policy from time to time. The effective date above shows when this version became effective.

Legal

Terms of Service

Effective date: April 30, 2026

Business Use Only

This website and our services are intended for companies and authorized business representatives only. By using this website or contacting us, you confirm that you represent a company and have authority to make inquiries on its behalf.

Website Information

The content on this website is provided for general business information only. It is not medical, legal, regulatory, tax, or investment advice and should not be relied on as a substitute for professional advice tailored to your situation.

Services

Any consulting, biostatistics, statistical programming, biometrics oversight, or related services will be governed by a separate written agreement or statement of work. No service relationship is created merely by visiting this website or sending an email.

Confidentiality

Please do not send confidential, proprietary, patient-identifiable, protected health, or regulated information unless we have a written agreement in place that permits the exchange. If you send information without such an agreement, we will treat it as a business inquiry and not as information subject to special confidentiality obligations.

Acceptable Use

You may not misuse this website, interfere with its operation, attempt unauthorized access, introduce malicious code, scrape the site in a manner that burdens hosting resources, or use it for unlawful purposes.

Intellectual Property

All website text, layout, design, graphics, and other content are owned by us or used with permission unless otherwise stated. You may view the site for internal business evaluation, but you may not copy, modify, distribute, or commercially exploit site content without written permission.

No Warranties

This website is provided "as is" and "as available." We do not warrant that the website will be uninterrupted, error-free, secure, or suitable for any particular purpose.

Limitation Of Liability

To the maximum extent permitted by law, we will not be liable for indirect, incidental, consequential, special, exemplary, or punitive damages arising from use of this website.

Governing Law

These Terms are intended to be governed by the laws of the State of California, without regard to conflict-of-law rules, unless a separate written agreement states otherwise.

Contact

For questions about these Terms, contact contact@kco-consulting.com.

© 2026 KCO Consulting LLC. All rights reserved.
Home Privacy Policy Terms of Service

Attention

1. This website is for companies only and does not use cookies.

2. Confirm that you represent a company.