Independent Statistical Center

INDEPENDENT STATISTICAL CENTER

Independent Statistical Center (ISC)
Services for Data Monitoring Committees (DMCs)

An experienced team enabling informed DMC decision making, preserving trial integrity, protecting patient safety, and providing superior service to clinical trial sponsors.

Why Your Independent Statistical Center Matters.

Data Monitoring Committees make critical recommendations on the conduct of your clinical trial. They depend on timely, accurate, and unbiased data reporting delivered and presented by an experienced team.

Inference has over 30 years’ experience supporting interim decisions and final analyses on blockbuster therapeutics. Having supported 100s of DMCs, we operationalize all aspects of ISC support so that your DMC can make the right decisions based on trusted data presented in a clear manner.

ISC Services

Logistics – DMC meeting scheduling and hosting
Documentation – DMC Charter drafting and reviewing, DMC meeting minutes and recommendations, Statistical Analysis Plans
Data – Data presentation planning, programming, and presentation
Design and Implementation – Group Sequential, Bayesian, Conditional Power, Sample Size Re-estimation, and other adaptive designs

We support DMCs across all phases of clinical research, all therapeutic areas, all trial & statistical designs, and across the lifecycle of each study. From study startup logistics, the DMC kickoff meeting, DMC data review meetings, adhoc analyses, to final database lock and study closeout, we are your trusted DMC partner.

Our ISC Approach

Our process and services align to FDA and industry standards on DMCs; delivering scientific rigor and operational excellence. Whether the study is frequentist or Bayesian, group sequential or promising zone, no matter the complexity of the design or interim analyses, we have the methodological expertise and processes to ensure accurate information is presented to the DMC for informed decision making.

Logistics and Infrastructure Setup

Secure Data Environments: We establish firewalled, access-restricted SharePoint environments for unblinded statisticians and programmers. All data, code, and communications are managed in compliance with regulatory and IT security standards.
Charter-Driven Planning: We interpret and implement your DMC charter requirements with clarity, including timelines, interim triggers, and reporting needs.

Pre-Study Preparation

Dry Runs and Validation: Our biostatistics team conducts thorough dry runs using blinded data to validate interim analysis code, reporting templates, and automated QC pipelines.
Familiarization with Study Design: Rapid onboarding to your trial’s endpoints, statistical design, and decision rules — including mixture Bayesian/frequentist thresholds.

Interim Analyses and Real-Time Execution

Secure Data Handling: Inference follows established SOPs to ensure datasets are production-ready and all data is managed securely so the DMC has confidence with the independent statistician.
Reporting: We deliver critical safety and efficacy outputs for each interim, including tables, listings, and figures—prepared under defined timelines and made immediately available to the DMC.
Secure Delivery: Outputs are uploaded to SharePoint in structured folders, with built-in control and access logging.

DMC Meeting Support

Statistical Presentation and Communication: Our lead unblinded statistician attends all DMC sessions (open and closed), presents findings, explains complex methodologies to clinicians, and documents the closed-session proceedings.
Rapid Query Resolution: We respond promptly to requests for revised or additional outputs between meetings.

Study Close-Out and Archiving

Comprehensive Archival: All data, code, meeting materials, queries, logs, and reports are securely archived and transferred to the sponsor upon study completion.
Transparency and Traceability: Every step is documented, reproducible, and audit ready.

WHAT SETS US APART

Experience: Knowing how to read the room. Understanding the data and displaying the information to the DMC immediately. Providing all the logistics required
Clinical-Statistical Communication: We bridge the gap between technical complexity and clinical relevance in every meeting.

Regulatory Alignment: We adhere to FDA, EMA, and best practices for DMC support.
Timely and Quality Deliverables: Outputs are delivered on time, every time—with no quality issues reported across studies.
Robust and Intuitive Sharing Tools: SharePoint’s controlled architecture makes file access seamless for DMC members.

REGULATORY ALIGNMENT

We follow global regulatory guidance:

FDA Guidance on DMCs (2023)
EMEA Guideline on Data Monitoring Committees
WHO Operational Guidelines for Data Safety Monitoring Boards

PARTNER WITH US

When you work with Inference, you gain a trusted partner with the experience, tools, and dedication to support your clinical development goals. Let us simplify the complexities in preparing regulatory documents so you can focus on delivering impactful therapeutic solutions. Connect with the Inference team to discuss further.