<img height="1" width="1" style="display:none;" alt="" src="https://px.ads.linkedin.com/collect/?pid=7238636&amp;fmt=gif">

BIOSTATISTICS & STRATEGIC CONSULTING

Transform Clinical Data into Decisions

From study design to regulatory submission, SDC delivers expert biostatistics, strategic insight, and AI + technology-enabled solutions that accelerate development and reduce risk.

biostats_tech_people_2273828-1

BIOSTATISTICS SERVICES

Biostatistics Across Every Clinical Trial Phase

A full complement of statistical services across the development lifecycle — delivered
by biostatisticians who partner with your team end to end.

Clinical Trial Design

  • Protocol development
  • Sample size calculations
  • Randomization schedule preparation
  • Statistical Analysis Plan (SAP) development
  • Representation at Regulatory Agency meetings
  • Statistical regulatory consulting
Clinical Trial Design

Clinical Trial Delivery

Clinical Trial Delivery

Regulatory Submissions

Regulatory Submissions

Automated Patient Profiles for Faster, Smarter Clinical Trials

AI-Automated Patient Profiles by SDC Insights™

SDC Insights™ transforms patient profile creation through intelligent automation, turning a traditionally time-consuming, manual process into a fast, scalable workflow. By automatically compiling and structuring critical patient data, including medical history, adverse events, medications, and clinical outcomes, SDC Insights™  generates comprehensive patient profiles in a fraction of the time required by conventional methods.
 
This enables clinical teams to access a complete, patient-centric view more quickly, improve review efficiency, strengthen data quality, and make informed clinical decisions with greater speed and confidence. The result is a more streamlined clinical trial process that reduces operational burden while accelerating study execution and patient safety oversight.

 

Key Features

  • Early Detection & Real-Time Monitoring
    Quickly identify data anomalies and potential safety concerns to support proactive risk management.
  • Comprehensive Patient View
    Consolidate medical history, adverse events, concomitant medications, and key clinical data into a single, structured profile.
  • Seamlessly Integrate into Existing Workflows
    Incorporate automated patient profiles into your current clinical processes with minimal disruption and maximum impact.
  • Rapid Implementation & Expert Support
    Leverage SDC's collaborative onboarding approach and dedicated clinical expertise for seamless adoption.
Key Features

Patient Profile Benefits

  • Reduce Profile Delivery Time by 80-90%
    Transform a 40-hour process into a 4-hour workflow, accelerating data review and trial progress.
  • Enhance Patient Safety
    Gain real-time visibility into patient data and detect potential issues earlier in the study lifecycle.
  • Strengthen Data Integrity
    Ensure consistent, structured, and reliable patient information across clinical operations.
  • Support Better Clinical Decisions
    Provide clinical teams with actionable insights that drive more confident, data-driven outcomes throughout the trial.
Patient Profile Benefits
Patient Profiles Automated

The Results

Up to 90% Time Savings: From 40 hours to 4 hours for key processes.
Lower Costs: Significant decrease in resource allocation and operational costs.
Accelerated Trial Timelines: Faster data processing leads to quicker trial completions.

SDCPatientProfilescopy-2-ezgif.com-video-to-gif-converter

STRATEGIC CONSULTING

Clinical Development Statistical Experts

SDC's statistical consultants work alongside sponsors to develop efficient study strategies, mitigate risk, and generate meaningful evidence. Whether supporting early program planning or preparing for critical regulatory interactions, our experts provide practical guidance backed by deep therapeutic and statistical expertise.

Strategic Statistical Consulting Services:

  • Clinical program development
  • Interim Analysis Strategy
  • Risk-Based Monitoring Plan development
  • Regulatory Meeting preparation and representation
  • Investor and Board meeting support
  • Ad hoc statistical analyses

 

Submission-Ready CDISC Deliverables

Regulatory submissions demand accuracy, consistency, and compliance. As a CDISC Registered Solutions Provider, SDC delivers standards-based datasets and submission packages that streamline regulatory review and reduce submission risk. Our experienced team ensures your data is organized, validated, and prepared for regulatory success. 

CDISC Services:

•    SDTM Dataset Development
•    ADaM Dataset Development
•    Define-XML Creation
•    Reviewer Guides
•    Open CDISC / Pinnacle 21 Validation
•    ISS and ISE Development
•    Legacy Data Conversion
•    End-to-End Submission Package Preparation 

PK/PD Analysis


Advanced Pharmacokinetic & Pharmacodynamic Analysis

 SDC delivers comprehensive PK/PD analysis services that support informed dose selection, safety evaluations, and clinical decision-making. Our team combines scientific expertise with proven methodologies to generate reliable analyses across a broad range of therapeutic areas and study types.  

Learn More
Blog_Cardmodule_PKPD Blog

PK/PD Study Experience

  • Single Ascending Dose (SAD) studies
  • Multiple Ascending Dose (MAD) studies
  • Healthy Volunteer studies
  • Bioequivalence trials
PK/PD Study Experience

PK/PD Modeling Capabilities

  • Phoenix™ WinNonlin®
  • Non-compartmental analysis
  • Two-Compartment Modeling
  • Dose Proportionality Assessments
  • BLQ data handling with sensitivity analyses 
PK/PD Modeling Capabilities

EMPOWER CLINICAL DECISIONS

Turn Data into Decisions with Expert Biostatistics

From study design through final analysis, we deliver the statistical expertise and technology-enabled solutions needed to advance development programs with confidence, efficiency, and scientific rigor.

Let's discuss how our biostatistics team can help move your study forward.