Availability of clinical data through electronic trials have built downward pressure on the current analytical and reporting processes within clinical research and development. Moreover, the EDCs have enabled the rapid ramp up of the use of adaptive clinical trials, which look at early trends to assess the probability of success for the clinical trial or suggest a possible mid-course correction requiring greater use of real-time analysis and decision making.

Industry is fast requiring Interactive analytical and decisioning solutions to support the evolution of advanced clinical trial designs such as adaptive trials, which requires time reduction from data-in-the-database to the analysis of the data. Furthermore, industry is also prospecting frequent Interim Analysis and DMC review in a web-based, collaborative environment in a time-bound process to enable faster decision-making in an adaptive setup. Solution that allows high-performance computing enabling real time data analysis (especially the exploration of subsets) will work together to make the drug development process more efficient by supporting such advance approaches.

eNalyze adds value to the existing industry solutions utilized in day-to-day clinical data analysis needs. Such analytical platforms lack the standards based approach that is integrated and automated based on metadata.

eNalyze is a web based and scalable analysis and reporting platform supporting clinical statistical computing and controls in an interactive environment. eNalyze is scalable enough to support small to large portfolio of studies spanning across the geography. Leveraging industry standard metadata and pre-built library of hundreds of validated analysis conforming to various clinical computing needs, eNalyze adds great efficiency to the entire process of clinical data analysis and reporting. Analysis management feature with eNalyze further supports enrichment of this library by allowing users to add more standard or adhoc analysis and further register them under the integrated process environment. Apart from that, it also maintains a library of various adaptive analysis and forecasting algorithm supporting various operational as well as clinical analysis.

Analysis and reporting process within eNalyze is supported by business user friendly point-n-click configurations and can also be scheduled to auto-generate reports periodically based on a specific time or event.

eNalyze consists of an inbuilt life cycle management system that is capable of managing version and change control, enabling traceability of each output and also analyzing change impact in case of any change being made either at report configuration level or at data level. It allows users to be part of a geographically distributed, multi-study environment and still produce reports supporting interim analysis, subset analysis and/or the submission oriented clinical reports efficiently without compromising the validity and integrity of the trial results. Quality and analytical operations management team can easily produce key metrics, identifying who did what, when why and from where, at any point of time.

Change impact analysis within eNalyze provides an intuitive methodology for demonstrating the change impact and "what-if scenarios" that can support informed decision-making in real-time.

Highlighted below are some of the key features within eNalyze,

• Generates standard, regulatory submission ready tables, figures & listings within seconds
  
• Supports planned interim and subset analysis within adaptive trials setting.
  
• Ability to schedule & execute analysis based on time and event
  
• Pre-built library of validated analysis
  
• Integrates with multiple statistical softwares: SAS, R
  
• Ability to support multiple studies and geographically distributed user bases under single platform
  
• Virtual workspaces and role-based collaboration framework
  
• Built-in quality and compliance mechanism (21 CFR part 11)
  
• Role-based security | version control | change impact | audit trail | traceability | data blind management | electronic signature
  
• Built based on standard guidelines and best practices - ICH-GCP, CDISC
  
• Generates tables, listings & graphs by both SDTM and ADaM data models
  
• Computes descriptive statistics like Mean, SD, Median, Confidence Limits, etc, for numeric data and multi dimensional frequency distribution tables for categorical data
  
• Provides P-values for Testing Statistical Significance using different statistical methods like Chi-square, Fisher exact, ANOVA, ANCOVA, Log Rank Tests and so on.
  
• Easily performs Subgroup Analysis
  
• Generates different graphs like Box plot, Error Bar chart, Survival Curves and so on.

eNalyze is a true productivity booster, whilst a strong control environment supporting quality and compliance level reports at the finger tips. It supports integration with multiple statistical packages allowing users to leverage multiple statistical software packages under a single environment without worrying about managing them, and makes it the most desired computing and control environment that industry needs currently.

eNalyze also complements existing enterprise systems, allowing you to wrap and renew your existing content sources protecting the investments you have already made.

Biostatistician, Statistical Analyst, Clinical Data analyst, Data scientist, Data monitoring committee, statistical committee, Clinical Data Management, and other functional users in Pharma, Biotech , Medical Devices and Academia.

eNalyze is a web based enterprise grade application developed with zero client footprint, available as an enterprise Cloud and also as Software as a Service.

As an end user, all you need is a web browser running on any systems with following minimum configuration.

• Supporting browsers; Mozilla 3.0 or higher and Internet Explorer 7.0 or higher with creation of cookies enabled.
• Running on any flavour of Windows operating system with 1GB of RAM. (Support for Linux will provided in next releases).
  
• Adobe flash 10 browser plug-in or higher.

eNalyze is also available for enterprise leasing for your private cloud or in-house deployments. For System Requirements and pricing, please contact sales@maxisit.com