SEMAB CLINICAL RESEARCH INC. (SCRI)

info@semabcri.ca

SEMAB CLINICAL RESEARCH INC. (SCRI)

info@semabcri.ca

BIOSTATISTICS AND DATA MANAGEMENT SERVICES

BIOSTATISTICS AND DATA MANAGEMENT SERVICESBIOSTATISTICS AND DATA MANAGEMENT SERVICESBIOSTATISTICS AND DATA MANAGEMENT SERVICES

Find out how we provide our client timely and effective Statistical and Data Management services!

Contact Us

BIOSTATISTICS AND DATA MANAGEMENT SERVICES

BIOSTATISTICS AND DATA MANAGEMENT SERVICESBIOSTATISTICS AND DATA MANAGEMENT SERVICESBIOSTATISTICS AND DATA MANAGEMENT SERVICES

Find out how we provide our client timely and effective Statistical and Data Management services!

Contact Us

About Us

Our Mission & Values

Experience the Difference

Our Mission & Values

Our mission, values, and culture at SCRI have helped us maintain best customer satisfaction and on-time delivery of key milestones. 

How We Help

Experience the Difference

Our Mission & Values

We empower our experts to engage with our clients as an extension of their team because we believe that the key to a successful project begins with having the right people on your team.  

Experience the Difference

Experience the Difference

Experience the Difference

SCRI is committed to providing experienced teams who will take ownership of your needs and are positively engaged in your projects.

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Our Services

Statistical Consulting

 

Statistical 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 SCRI 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

Biostatistics Services

SCRI’s top-tier biostatisticians are experts 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.


  • 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


Data Management Services

With deep expertise in Biostatistics, Clinical Data Management/EDC, Interactive Response Technology (IRT), and Data Monitoring Committee (DMC/DSMB) services, SCRI'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, SCRI is The Right Partner For You. 

 

  • 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

Contact Us

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SEMAB CLINICAL RESEARCH INC.

3351 Markham Road, Toronto, Ontario M1X 0A6, Canada

Ph: 416-432-8646 email: info@semabcri.ca

Hours

Monday - Friday: 8:00am - 5:00pm

Saturday - Sunday: Closed

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