SERVICES

• Consulting Services
• Statistical Analysis & Programming
• Clinical Trial, Clinical Research Preparation, & Clinical Trial Design

Whether clients require rapid consultations on an intricate study concept, development of statistical methodologies to align with modified study protocols, or Certified Research Associates (CRAs) for clinical trial management, MMRI possesses the in-house expertise to exceed client expectations. Our client-focused perspective facilitates client communications, thorough understanding of client issues and products, continuity of service quality, and ultimately cost-savings by reducing recurrent start-up times and disruptions for clients.

Furthermore, MMRI's many years of experience ensures knowledge of, and adherence to: safety, compliance, regulatory and reporting requirements.

Consulting Services

MMRI Consulting Services cover virtually all areas related to clinical trials and include:

• Research Study Consultations
• Analytic Methodologies
• BioStatistics & Epidemiological Issue Consultations
• Data and Safety Monitoring, including Advisory Services for DSMBs
• Professional Guidance Regarding Submissions to Regulatory Agencies
• IRB Services
• Clinical Trial Training for Staff
• Report, Presentation and Publication Consultacies
  

Clinical Trial Design, Clinical Research Preparation, and Clinical Trial Implementation

MMRI's involvement with clinical trials ranges from comprehensive involvement from start to finish to clinical trials or research projects where MMRI manages a particular element(s) for clients. Either way, our overarching objective remains the provision of high quality service to clients.

• Innovative Study Design
• Protocol Preparation
• Certified Research Associate (CRA) Staff Enhancement
• Data Management
• Phase I, II, III, IV Guidance, Support & Management
• Logistics Support
• Site Visits Conducted by CRAs
• IRB Management
• DSMB Management
• Quality Assurance
• Clinical & Statistical Reports
• Journal, Manuscript & Technical Reports
• Prepare Regulatory Reports
• Develop MOPs and SOPs
  

Statistical Analysis, Programming and Data Management

MMRI maintains a particular specialization in biostatistics and is well-known for its ability to provide real world solutions to complex problems in clinical trial design and data analysis using innovative statistical approaches and data analyses techniques.

Biostatistics

• Development of Statistical Methods for Protocols
• Experimental Design
• Sample Size / Power Calculations
• Randomization Schedules
• Efficacy and Safety Data Analyses
• Epidemiologic Analyses
• Statistical Methods in Clinical Chemistry, Laboratory Medicine and Medical Imaging
• Data Analyses/Meta Analyses for Regulatory Applications
• Analysis of Large Complex Data Sets
• Phases I-IV, Registries, Cohorts, Post-Marketing Research, Outcomes Research
• Service on Data Monitoring Committees and Data Safety Monitoring Boards
• Statistical Analysis Plans
• Stand Alone or Integrated Statistical Reports
• 21 CFR Part 11 Compliance, ICH Compliance
  

SAS Programming

Comprehensive SAS Programming including but not limited to: Programming for Efficacy Tables, Listing and Graphs; Automation of Reports; Interim Analysis; Data Cleaning; Development and Generation of Analysis Datasets; Customization and Validation of SAS Programs and Macros; Data Warehousing.

• SAS Programming for Efficacy Tables, Listings and Graphs
  
• SAS Programming for Safety Tables, Listings and Graphs
  
• Automation of Reports, Tables, Listings and Graphs
  
• SAS Programming for Integrated Safety and Efficacy Summaries
  
• Safety Report Programming
  
• Interim Analysis Programming
  
• Data Cleaning
  
• Develop and Generate Analysis Datasets
  
• Customized SAS Programs and Macros
  
• Validation of SAS Programs
  
• Data Warehousing
  

Data Management

• Design and Review Case Report Forms
  
• Design Custom Databases
  
• Develop and Perform Data Edits
  
• Data Validation / Verification
  
• Medical Term Coding
  
• Quality Assurance Procedures
• Data Manipulation
  

Clinical Areas of Expertise

• Medical Imaging Technologies
• Animal / Veterinarian Research and Medicine
• Therapeutic Areas of Expertise
  • Adolescent Development
  • Cardiovascular Disease
  • Diabetes
  • Adolescent Development
  • Behavioral Medicine
  • Oncology
  • Cerebrovascular Disease
  • Cystic Fibrosis
  • Diabetis Retinopathy
  • Hepatitis
  • Hemophilia
  • Hypertension
  • Nutrition
  • Obesity
  • Pulmonary Disease
  • Sickle Cell Anemia
  • Infectious Diseases
  • Pediatrics