Biostatistical Services for Clinical Trial and Drug Development

     
   
 

Introduction


Clinical trials and drug development play a promising role in shaping the course of today's healthcare industry. They help in determining whether new drugs or treatments are both safe and effective for use in human beings.

There are many aspects or phases in clinical trial and drug development, all are provided equal importance. Biostatistics is one such important task involved in clinical trials and drug development. Collected data is analyzed by biostatisticians and medical doctors as to the reliability and medical significance of the trial result and drug development.

It is highly advisable and indeed a practise to use only expert professionals and/or agencies to perform the tasks since millions of dollars and the reputation of the company conducting the research is at stake.

 

Our Core Strenghts


Analytics World has access to a team of skilled statisticians, statistical and SAS programmers qualified in developing biostatistical design and analysis of clinical trials as well as developing programs in SAS software for allowing statistical analysis to be performed and creating output.

We also have access to professionals with paramedical, medical, scientific / biotechnology, mathematical, engineering and / or manufacturing background to supplement our core team. Together, they make a team of qualified individuals experienced in finding critical insights into core strategies and strategic policies.

 

Biostatistical Services

Analytics World provides services and solution to its customers in the areas of Knowledge Management, Discovery Informatics and Clinical Trial Data Management.

The four components of Knowledge Management task of a discovery scientist are to identify, capture, store and retrieve the information. Utilizing its in house developed tools and competencies in the areas of Text Mining, Web Mining and Visualization, Analytics World offers its customers customized Knowledge Management solution.

Business is based on business collaboration with a leading global company and our competencies in Computational Chemistry. Analytics World helps its customers to discover and prioritize drug targets, identify virtual hits against chosen targets and for lead optimization.

Data Storage, Retrieval, Analysis and Report Writing as per the regulatory agencies audit rules continue to be the major bottleneck in the CRO space. Analytics World has entered into the space recently and is offering its customers the following services:

  • Case report form (CRF) development and electronic data capture (EDC)
  • Clinical data management (CDM) including CRF planning and distribution (whether electronic or paper)
  • Clinical data archiving/warehousing and management
  • Data analysis
  • Monitoring and reporting

PRODUCTS AND SERVICES

 
             
 
Discovery Informatics
Text Mining
Clinical Trial Data Management
 
         
    Identify, Capture, Store and Retrieval of information   Text Mining Software Development to process Biological/Chemistry concepts   Case report form (CRF) development and electronic data capture (EDC)  
               
    Knowledge Management System development   Database Development for various organisms using the in house developed software   Clinical data management (CDM) including CRF planning and distribution  
               
    Distribution of Tripos Suite of Products & Technical Support   Clinical data archiving/warehousing and management   Target Identification & Validation  
               
    Data analysis   Computational Chemistry; Hits and leads identification   Monitoring and Reporting  
               
 

As a promise of integrity and quality to our clients Analytics World follows Standard Operating Procedures for any statistical services provided to its clients. If the client has the need then Analytics World will prepare a Protocol Specific Procedures in conjunction with its clients.

We also assist in producing clear and concise Integrated Summaries of Safety (ISS) & Efficacy (ISE) reports and provide continued support for electronic submissions in adherence to the regulatory guidance.

 

Biostatistical Capabilities


Analytics World provides bio-analytics services by designing best statistical methods, choosing the appropriate analysis tools. The study can either be conducted for an investigator-initiated publication or planned for regulatory submission.

Our analysts use the most sophisticated analytical software programs, including SAS and SPSS to perform data mining and to rapidly analyze data to support clinical decisions. Analyticsworld’s analytics capabilities include both statistical programming using SAS, and biostatistics as detailed below.

Statistical Programming

  • Data integration
  • Customized displays
  • Macro program library
  • Programming for automatic edit checks
  • Statistical quality control procedures

Biostatistics

  • Protocol design
  • Sample size calculations
  • Randomization schedules
  • Statistical analysis plan and Mock-up tables
  • Interim analyses
  • Statistical analysis and interpretation
  • Full and abbreviated clinical study reports
  • Data mining
  • Statistical consulting

Statistical Techniques

  • Descriptive Statistics
  • Reliability analysis and Construct validity analysis
  • Correlation and Regression
  • Anova and Manova
  • Chi-square and t-tests
  • Nonparametric tests
  • Factor analysis
  • Derived Importance Calculations
  • Perceptual Maps
  • Multivariate Analysis (PCA, PLS etc)
  • Clustering Techniques
  • Survival analysis, Power analysis, Interim analysis
  • Signal Processing Techniques etc
 

Outsource to Analytics World


Analytics World’s qualified statisticians and programmers can deliver better quality and on-time completion of projects in all areas of clinical trial and drug development including analyzing, summarizing, reporting and exchanging clinical databases and statistical data sets.

For long-term prospects you can opt for a Joint Venture with Analytics World. With Analytics World, you can expect a long-term partnership for all your research and analytics activities. Get in Touch with us to have our representative contact you immediately!