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

N

Clinical Trial Design

N

Protocol Development

N

Sample Size Calculations

N

Representation at Regulatory Agency Meetings

N

Statistical Regulatory Consulting

N

Randomization Schedule Preparation

N

Statistical Analysis Plan (SAP) Development

N

SAS Programming and Independent Validation of Tables, Listings, and Figures

N

Interim Analysis Planning

N

Topline Analysis Package

N

Final Analysis Package

N

DMC Statistics Services

N

PK/PD Analysis

N

Rescue Study Services

N

CDISC Deliverables

(SDTM, ADaM, Define)

N

CDISC Conversion of Legacy Data

N

Integrated Summaries of Safety and Efficacy

(ISS/ISE)

N

Statistical Reports

N

Statistical Review of Clinical Study Report

(CSR)

N

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.

N

Clinical Program Development

N

Clinical Trial Design

N

Protocol Development

N

Sample Size Calculations

N

Interim Analysis and DMC Planning

N

Risk-Based Monitoring Plan Development

N

Regulatory Meeting Representation

(Pre-IND/IDE through Submission)

N

Ad-Hoc Statistical Analyses

N

Investor or Board Meeting Support

N

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

N

Integrated Summaries of Safety and Efficacy (ISS/ISE)

N

CDISC Formatting

(ADaM, SDTM, Reviewer’s Guide, and Define.xml)

N

OpenCDISC Validation

(Pinnacle 21)

N

Legacy Data Conversion

SDC is a CDISC Registered Solutions Provider and Gold Member. Learn more about CDISC at cdisc.org.

PK/PD Analysis

Pharmacokinetic/Pharmacodynamic Analysis

Pharmacokinetic Experience

N

Multiple Therapeutic Areas

Gastroenterology, Infectious Disease, Oncology, and Ophthalmology

N

Development and Delivery of Pharmacokinetic and Safety Report

N

Standardized PK Datasets in SDTM and ADaM Formats

Study Types

N

Single and Multiple Ascending Dose

N

Patients and Healthy Normal Volunteers

N

Bioequivalence Trials

Modeling

N

Phoenix™ WinNonlin®

N

Non-Compartmental Estimation

N

Two-Compartmental Estimation

N

Dose Proportionality Assessments

N

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.