Expert Data Services
Specialized Data Services for Clinical Trials
SDC’s specialized biometrics services ensure your data is handled with the highest quality and care.
With deep expertise in Biostatistics, Clinical Data Management, Interactive Response Technology (IRT), and Data Monitoring Committee (DMC/DSMB) services, SDC’s specialized data services ensure your clinical trial data is handled with the highest quality and care throughout your study. For end-to-end data services and industry-leading technology solutions, Empowering Clinical Decisions
Biostatistics
Getting The Most Out of Your Data
Data Management
Specialized Services for Your Study
Clinical Operations
Taking Clinical Trials Closer to Patients
IRT
Randomization and Inventory Management
DMC/DSMB
Helping You Make Informed Decisions
Safety/PVG
A unique alternative to traditional SAE data collection and reporting.
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.
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
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
Rescue Study Services
PK/PD Analysis
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)
Investor or Board Meeting Support
Ad-Hoc Statistical AnalysesManuscript 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)
Open CDISC Validation (Pinnacle 21)
Legacy Data Conversion
PK/PD Analysis
Pharmacokinetic/Pharmacodynamic Analysis
Pharmacokinetic Experience
Multiple Therapeutic Areas including 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
Data Management
Specialized Services and Technologies for Your Study
SDC’s fully integrated clinically focused solutions will enhance communication, streamline workflows, enable timely focused data capture, and provide optimized on-site and remote based monitoring (RBM) capabilities.
Data Managment Services:
Protocol Review
Optimal Technology Solution Recommendation
Risk-Based Monitoring Strategies
24/7 EDC Helpdesk
EDC Access Administration
Data Management Trial Master File Set-Up and Maintenance
CRF Design and Development
CRF Completion Guidelines (CCG) Development
Subject Diary Design and Development
Data Management Plan Development
Data Validation Manual Development
EDC System Training for Sites and Monitors
Clinical Database Creation, Validation and Auditing
Edit Check Programming, Validation, and Testing
Development of Custom Status Reports
Adverse Event, Concomitant Medication, and Medical History Coding
Import, Integration, and Cleaning of Electronic Data (Lab, ECG, PK, Diary, etc.)
Continuous Data Cleaning Throughout Study
Query Reconciliation
Independent QC Review
SAE Reconciliation between Safety and Clinical Databases
Database Lock
Study Archival
Data Managment Services:
Protocol Review
Optimal Technology Solution Recommendation
Risk-Based Monitoring Strategies
24/7 EDC Helpdesk
EDC Access Administration
Data Management Trial Master File Set-Up and Maintenance
CRF Design and Development
CRF Completion Guidelines (CCG) Development
Subject Diary Design and Development
Data Management Plan Development
Data Validation Manual Development
Clinical Database Creation, Validation and Auditing
EDC System Training for Sites and Monitors
Edit Check Programming, Validation, and Testing
Development of Custom Status Reports
Adverse Event, Concomitant Medication, and Medical History Coding
Import, Integration, and Cleaning of Electronic Data (Lab, ECG, PK, Diary, etc.)
Continuous Data Cleaning Throughout Study
Independent QC Review
Query Reconciliation
SAE Reconciliation between Safety and Clinical Databases
Database Lock
Study Archival
Clinical Operations
Fully integrated, end-to-end, quality and accuracy focused real-time cloud-based software
At SDC we are pleased to offer clinical operations support and full-service electronic decentralized/virtual clinical operations capabilities and state of the art, fit for use, technology solutions that allow for innovative, fully integrated, end-to-end, quality and accuracy focused value, real-time cloud-based software as a service (SaaS) solutions for conducting clinical trials.
SDC’s fully integrated clinically focused solutions will enhance communication, streamline workflows, enable timely focused data capture, and provide optimized on-site and remote based monitoring (RBM) capabilities.
Accelerated Study Start-Up and Site Activation Capabilities:
Electronic Feasibility Surveys
Real-time visibility to site recruitment and performance metrics
Portal that provides a centralized location for accessing and sharing all study information remotely with reduced need for site visits
Clinical Operations Services
Site Feasibility
Site Selection & Qualification
Site Initiation & Close Out
Remote Clinical Monitoring
Centralized Data Review
Risk Based Monitoring (RBM)
Safety & Pharmacovigilance
Clinical Operations
Fully integrated, end-to-end, quality and accuracy focused real-time cloud-based software
At SDC we are pleased to offer clinical operations support and full-service electronic decentralized/virtual clinical operations capabilities and state of the art, fit for use, technology solutions that allow for innovative, fully integrated, end-to-end, quality and accuracy focused value, real-time cloud-based software as a service (SaaS) solutions for conducting clinical trials.
SDC’s fully integrated clinically focused solutions will enhance communication, streamline workflows, enable timely focused data capture, and provide optimized on-site and remote based monitoring (RBM) capabilities.
Accelerated Study Start-Up and Site Activation Capabilities:
Electronic Feasibility Surveys
Real-time visibility to site recruitment and performance metrics
Portal that provides a centralized location for accessing and sharing all study information remotely with reduced need for site visits
Clinical Operations Services
Site Feasibility
Site Selection & Qualification
Site Initiation & Close Out
Remote Clinical Monitoring
Centralized Data Review
Risk Based Monitoring (RBM)
Safety & Pharmacovigilance
Interactive Response Technology (IRT)
Automating Randomization and Inventory Management
SDC’s IRT randomization services can make even the most complex clinical trials run smoothly and efficiently.
Also known as IWRS (Interactive Web), IRT automates patient randomization, kit assignment, drug supply, and inventory management. Streamline your clinical trial with SDC’s comprehensive IRT solutions.
iMedNet eClinical
Medidata Rave RTSM (formerly Balance)
Oracle ClinicalOne
Suvoda
IRT Features
Automated Randomization for Single or Multi-arm, Centralized or Multi-stratification, and Restricted & Forced Randomization
Inventory Management including Trigger-based Resupply, Predictive Resupply, and Drug Expiration Management
Seamless Integration with EDC/eClinical System
Comprehensive Field Level Blinding
Blinded and Unblinded Reporting
Emergency Unblinding
Customizable Inventory Statuses
iMedNet eClinical
Medidata Rave RTSM (formerly Balance)
Oracle ClinicalOne
Suvoda
IRT Features
Automated Randomization for Single or Multi-arm, Centralized or Multi-stratification, and Restricted & Forced Randomization
Inventory Management including Trigger-based Resupply, Predictive Resupply, and Drug Expiration Management
Seamless Integration with EDC/eClinical System
Comprehensive Field Level Blinding
Blinded and Unblinded Reporting
Emergency Unblinding
Customizable Inventory Statuses
Data Monitoring Committee Services
Helping You Make Informed Decisions
The Data Monitoring Committee (DMC) is an integral part of many clinical studies. SDC provides expert statisticians to analyze your data for safety review and DMC meetings.
Our team has supported DMC/DSMB meetings as subject-matter experts in a variety of therapeutic areas, including: Dermatology, Gastroenterology, Immunology, Infectious Disease, Neurology, Oncology, and Ophthalmology.
DMC/DSMB Data Services
Development of Stopping Rules
Independent Reporting Statistician
Voting Statistical Board Member
Charter Development/Authoring
Unblinded DMC Team Independent of Blinded Study Team
Table, Listing, Figure Development and Production
Rapid Turnaround of Ad-Hoc Requests
Integration of Pharmacovigilance Data
Safety / Pharmacovigilance (PVG)
SDC recognizes the importance of robust yet flexible solutions when it comes to SAE data collection and reporting, and as such we now offer multiple integrated options to meet your safety/PVG needs.
eSAE workflow within EDC
SDC is proud to be the first CRO to offer our clients a unique alternative to traditional SAE data collection and reporting.
For studies not requiring global safety reporting or surveillance, SDC offers an eSAE solution: