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Our clinical programming team has over 20 years of pharmaceutical experience. The team is led by senior statisticians and programmers who have been with leading pharmaceutical companies during their extensive tenure prior to joining the MMS Holdings team. Our group brings hands-on experience to every project we undertake. We listen to our clients' needs and expectations very thoroughly and provide creative solutions to all programming needs. We are focused in specialized areas of services where we surpass any traditional CRO and always strive to exceed client's expectations.


  
Programming Services
Statistical Services
 
We provide the following services under Clinical Programming:
 
Tables/Listings/Graphs (TLGs) Programming & Support:
Phase I-IV Clinical Study Reports
Interim Analysis
Blinded Data Review
Drug Safety Monitoring Boards
Manuscripts, Publications and Posters
Ad Hoc Reports
   

Submissions:

Creation of Integrated Databases
TLGs to Support ISS/SCS
TLGs to Support ISE/SCE
Submission Ready Transport files (CDISC standards as required)
Patient Profiles/Listings
Product Defense
- Rapid Responses
- Regulatory Queries (FDA & EMEA)
- Ad Hoc and What If Scenarios
Assistance with Design of Integrated Databases, Transport Files and Patient Profiles
   

Other Programming Capabilities:

Creation of Derived Datasets for Statistical Analysis
Patient Summaries for Narratives
Creation of TLG Requirements/Specifications
Programming Code and Validation/QC Documentation
Adherence to System Development Lifecycle (SDLC) Processes
   
 
 
We provide the following services under Biostatistics:
 
Study Design:
Advice on Matters of Study Layout
Evaluation of the Optimality of Selected Efficacy Parameters in Terms of Statistical Properties
Sample Size Determination
Statistical Analysis Plan Composition
   

Data Analysis:

Blinded Data Review
Interim Analyses
Review of Third-Party Data Analyses
Data Analysis for Studies Spanning Drug Discovery – Phase IV
Submission-related Statistical Support
   
General Statistical Consulting:
Assistance with the Composition of Statistical Results Summaries for Clinical Study Reports
Assistance with the Creation of Manuscripts, Posters & Oral Presentations for Internal/External Presentations
Advice on Data Visualization (Statistical Graphics)
Review of Statistical Matters Pertaining to Compound Acquisition, New Methods Development, Technology Acquisition or External Published Claims
   

Other Services:

Creation of Custom-Designed Courses for Teaching Statistics to Non-Statisticians
Instruction in Basic Statistical Methods for Non-Statisticians
Assistance with the Creation of SAS® Tools (Macros) for Statistical Analyses Not Currently Available in the STAT Product
   
 
 
 

 

 
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