Biostatistics
Getting The Most Out of Your Data
SDC provides expert biostatistics services for all phases of clinical development.
Our top-tier biostatisticians are leaders in applying statistical concepts to design and execute efficient clinical trials.
Supporting our clients from protocol design through regulatory submission and defense, our biostatistics team helps interpret your data so that you can make informed decisions about your clinical program.
Statistical Consulting
Designing Effective Clinical Trials
CDISC Deliverables
Submit Your Data (SDTM, ADaM, Define) with Confidence
Pharmacokinetic/Pharmacodynamic Analysis
Pharmacokinetic/Pharmacodynamic Analysis
Biostatistics Services
Clinical Trial Design
Protocol Development
Sample Size Calculations
Representation at Regulatory Agency Meetings
Statistical Regulatory Consulting
Randomization Schedule Preparation
Statistical Analysis Plan (SAP) Development
SAS Programming and Independent Validation of Tables, Listings, and Figures
Interim Analysis Planning
Topline Analysis Package
Final Analysis Package
DMC Statistics Services
PK/PD Analysis
Rescue Study Services
CDISC Deliverables
(SDTM, ADaM, Define)
CDISC Conversion of Legacy Data
Integrated Summaries of Safety and Efficacy
(ISS/ISE)
Statistical Reports
Statistical Review of Clinical Study Report
(CSR)
Manuscript Development
Statistical Consulting
Designing Effective Clinical Trials
Strategic consulting is a key component of our biostatistics service offering and is frequently a pathway for initiating new client relationships by demonstrating the value that SDC adds to your clinical program in this area.
From supporting your efforts in designing the most effective and efficient trials for your clinical program to representing you at regulatory meetings with FDA or other regulatory agencies, our statistical consultants are with you every step of the way.
Clinical Program Development
Clinical Trial Design
Protocol Development
Sample Size Calculations
Interim Analysis and DMC Planning
Risk-Based Monitoring Plan Development
Regulatory Meeting Representation
(Pre-IND/IDE through Submission)
Ad-Hoc Statistical Analyses
Investor or Board Meeting Support
Manuscript Development
CDISC Deliverables
Submit Your Data (SDTM, ADaM, Define) with Confidence
Looking for a CRO with CDISC experience? Let SDC prepare your data submission package so you can submit your data with confidence.
SDC is a CDISC Registered Solutions Provider for CDASH, Controlled Terminology, SDTM, ADaM, Define-XML, and Study/Trial Design Model standards.
Submission-Ready Data Services
Integrated Summaries of Safety and Efficacy (ISS/ISE)
CDISC Formatting
(ADaM, SDTM, Reviewer’s Guide, and Define.xml)
OpenCDISC Validation
(Pinnacle 21)
Legacy Data Conversion
PK/PD Analysis
Pharmacokinetic/Pharmacodynamic Analysis
Pharmacokinetic Experience
Multiple Therapeutic Areas
Gastroenterology, Infectious Disease, Oncology, and Ophthalmology
Development and Delivery of Pharmacokinetic and Safety Report
Standardized PK Datasets in SDTM and ADaM Formats
Study Types
Single and Multiple Ascending Dose
Patients and Healthy Normal Volunteers
Bioequivalence Trials
Modeling
Phoenix™ WinNonlin®
Non-Compartmental Estimation
Two-Compartmental Estimation
Dose Proportionality Assessments
Standard Handling of BLQ with Sensitivity Analyses
See why SDC is the Right Fit For You.
Contact us or email info@sdcclinical.com
Biostatistics Case Studies
Adaptive Clinical Trial Designs
Renowned experts Ken Getz (Tufts Center for the Study of Drug Development), Joe Massaro (Boston University), and Dale Usner (SDC) discuss Adaptive Clinical Trial Designs at SDC’s Grand Opening celebration in Waltham, Mass.
Biostatistics for Non-Statisticians: Understanding Different Types of Analyses and When to Use Each
Webinar Available On Demand
Efficient Solutions: A Clinical Partner Case Study
In this case study, see how SDC managed expedited PK timelines for a 19-week clinical trial.