Software Development For Life Sciences Industry

Published Date: 02 Nov 2017

Abstract – This report summarizes the B-Tech project undertaken by me in my eighth semester. It elicits my contribution in the software development process being carried out at Aris Global. The Company provides integrated software solutions in the life-sciences domain. The work done here involves designing, developing and deploying these software products for life-sciences companies. This report also gives a brief overview of the various tools and technologies used to develop the product.

Keywords – life-sciences, metadata, wireframes, metadata, framework

Introduction

Life Sciences industries is a generic term to encompass companies in the fields of biotechnology, pharmaceuticals, biomedical technologies, life systems technologies, medical device technologies,etc. Owing to concerns regarding the efficacy and safety of drugs most governments have developed regulatory agencies to administer development and marketing of drugs and medical devices. A lot of regulatory and reporting processes are undertaken and humongous volumes of drug affect –cases are to be dealt in order to comply with these agencies. Pharmaceuticals need solutions that enhance collection, assessment and evaluation of adverse event and adverse reaction data. To help life sciences industries deal with this needs several companies have come up with software solutions. Aris Global is one such organization which is at the herald of providing these kinds of solutions.

This document provides a synopsis of the software development process at Aris global Software Ltd. It gives a brief description of the company product lines and the life-Sciences domains it pertains too. The report will specifically focus on the modules of AgnVision product on which the B-tech project was based. The report will focus on the development process of the module Metadata designer for reporting tool. Also a major portion would be the development of interactive wireframes for AgnVision.

Problem- statement

The internship undertaken at Aris global involved two major tasks to be carried out.

To develop interactive wireframes for entire UI prototype of business intelligence reporting tool AgnVision

To design and develop Meta-Data designer for Adhoc reporting tool

Aris Global overview

Aris Global provides integrated software solutions in the life-sciences domain. It caters to pharmaceutical companies, drug regulatory agencies and other medical device industries by providing software solutions that help in swifter development of drugs and that are in compliance with the global standards.

These software solutions help in maintaining regulatory compliance, mitigation and management of risk, and in enhancing operational efficiency. The hosted, managed platform enables companies to achieve quickly implement cost-effective solutions for drug safety, pharmaco-vigilance, clinical trials management, EDC (Electronic data capture), and regulatory tracking.

The company aims to aid life-sciences companies to deal with the challenges of bringing safer thoroughly scrutinized, risk-free drugs faster and more cost-effectively to the market

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Fig. 1 An overview of the products developed by Aris Global categorized on the basis of life-sciences domain.

Aris Global solutions can be deployed stand-alone or together, hence enabling organizations for collaborating across various departments. 

Also to serve companies which wish to cut down their budget on IT infrastructure, easy product maintenance and faster implementation the company has adopted the Software as a Service (SaaS) approach through its agOnDemand product. Companies can leverage this platform for any of the life-sciences solution.

AgnVision Overview

It is a business intelligence and Reporting tool catering to the analytics and reporting needs of life-sciences domain industries like pharmaceuticals and drug regulatory agencies.

Application will use centralized data warehouse for reporting, analysis, metrics and compliance tracking purposes spanning the complete case processing life cycle of a drug in the life-sciences industry. The application is conceptualized to be the master application to various reporting and analytics application from ArisGlobal.

It is a product still under development and is set to have rich features like Report Generation and scheduling, Metadata-designer, Dashboard-designer, Data-Mining, Workflow-Designer and Dossier creation. It will consist of several standard pre-built reports which cater to several regulatory needs and other complex aggregate reports for life-sciences like PBRER (Periodic benefit risk evaluation report) PSUR( Public safety Update Reports), etc.

A consistent set of technologies are being used for development most of the components (modules) of AgnVision.

Tools and used Technologies :

Most of the software development undertaken at aris global is done using the Java EE framework. Apart from that certain standard tools and technologies used in AgnVision are as described.

Maven: Apache Maven is an open source software project management and comprehension tool for managing a project’ build. The entire project structure is maven based. It helps in easy dependency management and provides an easy to maintain project structure. It is used independently or more conveniently configuring it as a plugin in Eclipse IDE.

Hibernate: Hibernate is an open source Java persistence framework project. It is a popular ORM (Object Relation Mapping) tool for mapping java classes to relational database tables. It is extensively used as it facilitates easy mapping via xml files or java annotations and provides a database independent implementation. It also provides data querying and retrieval facilities.

JSF: It stands for Java Server Faces. It is a Java based web application framework for building User interfaces and websites. It is a component driven model which uses xml files (facelets). Xml stands for Extensible Markup Language which helps to formulate a set of standard conventions for encoding documents that can be understood by machines.

Primefaces: It is an open source component library for JSF and provides a collection of already built UI widgets. They are AJAX based and offer an addition to the basic set of components available in JSF.

Spring framework: It comprises of an extensive programming and configuration model for modern Java-based enterprise applications - on any kind of deployment platform. It lays emphasis on focusing on application-level business logic, decoupling implementation form specific deployment environments. Its core modules consist of IOC (Inversion of Control) container which facilitates Dependency injection. Other very helpful feature is AOP (Aspect Oriented Programming) which helps in automating activities like logging, transaction management, etc. This enables the developer to focus more on actual development activity.

Eclipse IDE: It is a multi-language software development environment developed in java comprising of a huge extensible set of configurable plugins to support other technologies and tools. The Eclipse Indigo or Juno version is used for most of the software development activity carried out in the company.

Apache Tomcat: It is an open-source application deployment web-server. It is generally configured with Eclipse-IDE to test the web pages during development of the application.

interactive ui prototypes for agnvision

It is an integral part of the requirements specification and design of the product AgnVision. Several approaches are used for developing mock-up screens. Very crude approaches include drawing web-pages layout on paper or using other design softwares to create mock-up screens. A better, professional, sophisticated and widely used approach is the creation of interactive wireframes.

A website wireframe, also known as a page schematic or screen blueprint, is a visual guide that represents the skeletal framework of a website.Wireframes are created to develop a prototype of the actual product. It is used to obtain an idea of how the product would look before the product is actually developed and is very good way to extract customer requirements and feedback. It is very useful in conveying the interactivity among various components and web-pages to the developers and customers alike. The actual design of the product is then carried out adhering to the requirements elicited and feedback gathered after the demonstration of the prototype to the customer. Wireframe provide a tangible understanding of the underlying conceptual structure behind the website design. They help establish functionality, and define navigation between different screen templates of a website. An iterative process, creation of wireframes is a very potent approach to develop rapid prototypes of webpages, while measuring the practicality of a design concept.

tools and technologies used for developing wireframes

The tool used for creating wireframes for AgnVision was Axure RP.

It helps in creating interactive html prototypes for website or any web based products as well as smart-phone applications. It has rich features with a very user-friendly interface that facilitates adding components using drag and drop functionality. It helps in creating standard mock-up pages without any coding effort.

Fig. 2 Admin Module Created in axure: Consists of interactive pick-list as well as navigation configured tabs.

The framework chosen (Axure) for it has a lot of benefits:

It helps in easier framing and specification of requirements

It supports both windows as well as Mac-OS platforms

It helps to better interact with the customers and gather their requirements / feedbacks as they get to see an interactive demo of the actual website or product.

It is very convenient for developers to get along with developing as they have a more clear understanding of the design and interaction of widgets and pages.

It is very convenient to work in a distributed manner as the software facilitates easy integration of independently created wireframes.

Most important of all it is very easy to learn and boasts a very rich tutorial set on its website.

Creation of the ui prototypes

The task of creating the prototype for the entire product is divided into creating individual modules and then integrating them into one ‘RP’ (Axure project) altogether.

Creating of modules and underlying pages is very convenient due to the drag and drop functionality provided by the axure interface Interactions among components and pages is also easily accomplished by adding cases to various pre-defined actions supported by Axure.

Few Snapshots of the modules developed are

Fig. 3 Dossier screen wireframe created using Axure

Fig. 4 Dashboard designer wireframe: It is a interactive wireframe with drag and drop functionality as well as customizable chart.

Metadata designer

A reporting tool requires metadata generated from a database to be loaded into it for generating reports.

Metadata is basically used as an intermediate layer between end user application and the database. It is a kind of index which contains pointers leading the user to content relevant to him for his reporting needs.  Metadata definition in a broad sense is figuring content helpful for a specific purpose. This is done based on the categorization of reports in life-sciences domain, each category defining its own hierarchy of tables (tree structure). This assists users by narrowing down the set of points to analyse. Hence Metadata is a subset of the actual database definition consisting of entities relevant to create reports, as well as additional information enriching the process of reporting.

This process of metadata definition was done manually by writing SQL queries. This is a very tedious way of injecting the metadata into the reporting tool. Also changing it requires the same cumbersome process. Hence a metadata generator would provide a great deal of help in easy generation of metadata to be loaded in the reporting tool. Hence owing to such requirements the tool was proposed to be designed.

Currently the Aris Global report generation tool is Adhoc Report. It uses Metadata collected form a database warehouse to generate life-sciences domain reports as per the report template defined. It faces this complex issue of having metadata generated manually by injection using SQL queries. Hence to automate this process and make it less wearisome this product would be used.

This application was set to be used as a stand-alone module for the reporting tool Adhoc report as well as a module of the product AgnVision. Hence the technologies and tools used are consistent with those used for AgnVision as mentioned in section 3B.

Creation of Metadata designer

The metadata designing process consists of the following stages:

Selection of the specific database on which the metadata is to be built.

Defining of groups

Selecting tables to be included in metadata. Facility to providing user context sensitive labels for the tables selected

Selecting fields of the respective tables selected to be included in metadata and their respective labels

Adding relationships between the fields selected to be incorporated in the metadata. This stage will also consist of proper validations that do not violate any of the constraints of the relational database model.

These steps will be developed as web-pages and rendered in the application in a sequential order and on completion of these steps the metadata will be generated and ready to be consumed by the reporting tool.

Development of UI components:

Owing to certain specific requirements the UI components available in prime-faces were not ready to be directly consumed. They required certain extent of modification to be made fit for the tool. Hence POC’s were developed for the requirement specific components designed. These were then properly tested using dummy as well as actual data available from databases to be consumed by report designer. On performing several iterations of design and review these components were approved to be fit for use.

Extracting data from databases and displaying on web-pages :

This was done using ORM mapping with the aid of hibernate tool. The data is extracted from the database tables and mapped to java classes. These data stored in classes is then displayed on web-pages, manipulated upon and again persisted in the respective databases.

The extraction of data was accomplished using native hibernate Queries in order to make the implementation database- provider independent. Junit test cases are developed that validate the database connections.

Fig. 2 Metadata Designer architecture

Integration of UI components and modules interacting with database :

The individual modules developed independently are to be integrated into single project. The screens containing the UI components are configured with the beans (java classes). These classes are connected logically to other DAO (Data access object) classes which interact with the database. Hence a component in compliance with all the functionality is available after this stage.

Fig. 3 Metadata Designer ‘fields’ page, first table shows a list of available fields pertaining to the table selected and table on right are the selected fields.

After this stage the product is sent to the User Experience Team for improvising on the UI so that the product is fit for shipping to the customers. The project is organized in a proper hierarchical structure adhering to the guidelines set forth during the design phase. This consists of proper refactoring of the project in to proper logical components, following standard agreed upon naming conventions, validating a consistent technology stack throughout all the components. This is very essential for future manageability of the code and to make it developer-independent.

Fig. 4 Metadata Designer ‘relationships’ page, the two tables depict a list of available fields from tables selected previously to define a relationship upon.

QC Testing:

The product developed by the development team is then passed forward to the QC (Quality Control) team before release. Software Quality Control checks whether the software project is in compliance with the standards processes, and procedures, and that the project delivers the desired internal outputs. This team performs an intensive testing process of the product and validates and verifies if it fits all the criteria and is fully functional without any flaws. After this the product is sent to the customer for approval and post it is deployed for use by him.

Conclusion

The development of Metadata designer is nearly on verge of its completion, and would be released owing to the feedback from QC testing team. As mentioned it will be used to supplement the reporting tool Adhoc report for generating metadata to be consumed by it for generating reports. Several more features for further releases. The AgnVision development would commence soon and I am supposed to be a part of the development team. The development of individual modules of AgnVision will go in accordance with the Requirements Specifications gathered and the wireframes created.

Apart from these tasks I was assigned with creating POC’s for storage and retrieval of PDF’s in the form of byte-streams making use of Mongo DB database.

Acknowledgment

I would like to thank Prof. Rahul Muthu my on-campus mentor, for providing me with an opportunity to intern with the company and also for his keen guidance throughout the project.

I also wish to thank my off-campus mentors Mrs. Deepa. T. Giridhar and Mr. Anish Anand for training and mentoring me and making me an integral part of the software development activity at Aris Global. Also a special mention to all the fellow interns and co-workers for helping me and making transition into the company environment as smooth as possible.