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Vitrana, Inc.

Cranbury, New Jersey, US

Vitrana is a Malagasy word literally meaning ‘a seam in a cloth’ and provides a useful metaphor for the company. VitranaTM consists of a group of health science IT practitioners coming together with a shared vision to drive major advances in the quality, efficiency and cost of clinical research, development and patient care through leveraging key technology innovations in clinical and healthcare information management.

Vitrana's mission is to develop an integrated healthcare and life sciences IT platform, providing both clinical and healthcare application hosting, maintenance and comprehensive integration services across the enterprise. Vitrana believes that clinical research, development and patient care can be significantly improved through the adoption of key technology innovations in information management, focusing both on bottom line costs and on top line growth, leveraging information assets for improved... Show more »

Vitrana is a Malagasy word literally meaning ‘a seam in a cloth’ and provides a useful metaphor for the company. VitranaTM consists of a group of health science IT practitioners coming together with a shared vision to drive major advances in the quality, efficiency and cost of clinical research, development and patient care through leveraging key technology innovations in clinical and healthcare information management.

Vitrana's mission is to develop an integrated healthcare and life sciences IT platform, providing both clinical and healthcare application hosting, maintenance and comprehensive integration services across the enterprise. Vitrana believes that clinical research, development and patient care can be significantly improved through the adoption of key technology innovations in information management, focusing both on bottom line costs and on top line growth, leveraging information assets for improved insights and service quality. These innovations include the emergence of cloud-based architectures and the development of standards-based platforms for clinical and healthcare data management.

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Healthcare IT Consulting
Price on request

The vast majority of drug safety case processing and regulatory reporting applications are licensed, commercial-off-the-shelf product offerings. These systems provide many of the features and functions that are necessary to run the core business, however no out-of-the-box application is able to suit the specific needs of any... Show more »

The vast majority of drug safety case processing and regulatory reporting applications are licensed, commercial-off-the-shelf product offerings. These systems provide many of the features and functions that are necessary to run the core business, however no out-of-the-box application is able to suit the specific needs of any particular organization. Not only has this, but requirements, regulations and technology evolved over time, prompting new product releases that require periodic system upgrades.

As a consequence of adopting a best-of-breed approach to application adoption, as well as strategically avoiding single product vendor dependence and lock-in, organizations tend to turn to system integrator to both implement the individual functional systems, but also to develop the necessary interfaces and integrations between these applications, to facilitate the end-to-end process flows. A simple example would be the transfer of adverse events from electronic data capture to the core safety systems and the transfer of source files, attachments from safety systems to centralized document repositories.

VitranaTM meets these challenges by providing expert consulting services to implement drug safety case processing and reporting applications, developing key integrations to support cross-platform process flows, and maintaining and upgrading the platform, both for on premise or hosted deployment models. The VitranaTM team are pioneers in cloud deployments and have worked with clients across the world who have realized the benefits of lower cost, of rapid implementation, and of closer alignment to the product road-map whilst ensuring the highest level of information security and data privacy.

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Project Management
Price on request

VitranaTM provides Project Management and/or coordination services for Oracle Health Sciences and other Clinical Research IT Implementations globally. We strive to provide quality and on-time delivery of ClinicalResearch IT projects consistently to our customers through our highly experienced Project Managers who are PMP certified and possess strong Life Sciences Industry and Technology skills.

VitranaTM provides Project Management and/or coordination services for Oracle Health Sciences and other Clinical Research IT Implementations globally. We strive to provide quality and on-time delivery of ClinicalResearch IT projects consistently to our customers through our highly experienced Project Managers who are PMP certified and possess strong Life Sciences Industry and Technology skills.

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Software Development
Price on request

VitranaTM‘s deep functional expertise on the Clinical industry solutions and applications is strongly coupled and complemented by the relevant and cutting-edge technology skills in helping Life Sciences organizations meet specific and ad-hoc solution needs.

Our dedicated team of technical and techno-functional experts help you... Show more »

VitranaTM‘s deep functional expertise on the Clinical industry solutions and applications is strongly coupled and complemented by the relevant and cutting-edge technology skills in helping Life Sciences organizations meet specific and ad-hoc solution needs.

Our dedicated team of technical and techno-functional experts help you build custom quality solutions, for example, to design and build custom data marts, custom reports and dashboards, provide standards based mapping services (SDTM), design and develop custom ETL Interfaces, load dictionaries, validation services etc. using the following tools and technologies:

  • Oracle Business Intelligence Enterprise Edition (OBIEE)
  • Spotfire
  • Oracle Data Integrator (ODI) 11g
  • Tableau
  • Oracle PL/SQL
  • Business Objects
  • Informatica
  • Cognos
  • JReview
  • SAS
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Clinical Electronic Data Capture (EDC)
Price on request

Today’s Life Sciences organizations face significant challenges in improving the quality of clinical services and meeting their regulatory compliance obligations. The success of life sciences organizations is predicated on many factors, but one that is particularly critical concerns the ability to fully leverage information assets... Show more »

Today’s Life Sciences organizations face significant challenges in improving the quality of clinical services and meeting their regulatory compliance obligations. The success of life sciences organizations is predicated on many factors, but one that is particularly critical concerns the ability to fully leverage information assets to maximum effect. The proactive and efficient processing of real-time information across the enterprise can provide up-to-the-minute, analytical insights that help an organization to make effective and informed decisions. In addition, effective sharing of information across business applications enhances both internal efficiency and quality of service for internal stakeholders and customers alike. However, more often than not, these information assets lie hidden within the individual applications, preventing organizations from realizing their true potential.

Clinical & Safety Systems – Need for integration

  • Clinical systems are Patient data driven system resulting in limited focus on capturing AE and Product information.
  • Drug safety system like Argus are AE data driven system which has Product and Event dependency
  • Clinical systems have different templates per trial, hence there are different forms for each trial
  • Argus has standardized case form and reporting across implementation
  • Clinical systems perform the reporting based on the CDISC, Whereas Argus does the reporting based on ICH E2B(R2)

The VitranaTM Health Sciences integrated platform comprises a standards-based, integration service that is agnostic to the specific application product and related technology foundation, developing and re-using core adapters for various commonly adopted, COTS products across the healthcare and life sciences domains. The platform aims to deliver improvements in:

  • data accessibility, transparency and visibility
  • operational efficiency, productivity and clinical outcomes
  • collaboration among research and patient care entities
  • identification of signals based on real-time events
  • data quality and access controls
  • total cost of IT ownership through re-use of integration technologies
  • regulatory compliance, including reporting
  • end user/patient experience

Our Integration Experience

  • Our team has lead and developed integration solutions for Argus using E2B+ at several Tier 1 pharmaceutical firms based out of US and Europe
    • Outgoing integration with Product Quality Complaints System
    • Bidirectional integration with Clinical EDC systems
    • Integration with Japan based system
  • SMEs with extensive experience of handling E2b profiles having more than 40 Extension tags
  • Exhaustive experience in customizing the standard ESM packages for custom business needs
  • Custom report development as part of integration needs

VitranaTM has a wide portfolio of key integration offerings for Oracle Health Sciences products that include:

  • Argus Safety and InForm
  • Argus Safety and Medidata Rave
  • Argus J and Common Master Database (CMDB)
  • Argus Safety with Siebel
  • CTMS with e TMF solutions
  • CTMS and Financial Applications
  • CTMS with EDC/CDMS applications
  • Clinical, PV and Healthcare Data Warehouse
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Business Development Consulting
Price on request

Rapid advances in science and technology, coupled with increases in regulatory requirements & Health Information Exchange, are posing a challenge for health science organizations to manage their business in a highly competitive landscape. An effective business intelligence solution based on a robust data warehouse provides a... Show more »

Rapid advances in science and technology, coupled with increases in regulatory requirements & Health Information Exchange, are posing a challenge for health science organizations to manage their business in a highly competitive landscape. An effective business intelligence solution based on a robust data warehouse provides a good foundation on which organizations can formulate and make effective clinical and business decisions. Healthcare Analytics solutions can help healthcare organizations improve their operational effectiveness, Revenue cycle management, profitability, quality of care whilst meeting their regulatory obligations. Maintaining and managing enterprise information assets centrally helps tremendously in improving reporting quality and making informed decisions.

Why BI Consulting?

  • Proper alignment of business with IT
  • Help the business in defining and tracking KPIs, through management reporting and dashboards
  • Provide a comprehensive, enterprise view of the information assets, with the right levels of access control
  • Design, build and develop data feeds for the warehouse
  • Assist in data analysis, integration, performance tuning and testing

How can VitranaTM Help?

VitranaTM has a range of consultants who have extensive domain expertise and experience in delivering end-to-end BI solutions and can help to establish an effective system to enhance competitive effectiveness. Our team brings expertise around :

  • Creation of new reports and management dashboards
  • Comprehensive solution for Health Information Exchange (Payer and Provider Integration)
  • Healthcare Provider – Patient Management
  • Solution that enables payer organizations to compete on customer centricity
  • Predictive Analytics Models to improve Patient Risk management
  • Generation of pixel perfect reports for paper documentation (compliance documents) including reporting solutions for the Japanese market
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Cloud Computing
Price on request

VitranaTM approach to Cloud Migration is guided by a comprehensive 9 stage program.

  • Landscape Scan
  • Model Selection
  • Hosting Partner Selection
  • Application Evaluation Criteria
  • Application Migration Strategy
  • Pilot Migration
  • Landscape Migration Plan
  • Migration Execution and Monitoring
  • Post Migration... Show more »

VitranaTM approach to Cloud Migration is guided by a comprehensive 9 stage program.

  • Landscape Scan
  • Model Selection
  • Hosting Partner Selection
  • Application Evaluation Criteria
  • Application Migration Strategy
  • Pilot Migration
  • Landscape Migration Plan
  • Migration Execution and Monitoring
  • Post Migration Stabilization and Steady State

The key consideration of Cloud Migration Design includes

  • Security Considerations
  • Compliance and Regulatory Considerations like PCI, HFMA, HIPAA, HiMSS, EHNAC, GAAP, SOX, ICD, and IFRS, HITECH, ICD-10, SOX, Patriot Act
  • Business Continuity Consideration

VitranaTM’s Cloud Migration Strategy is designed to minimize risk and application downtime. The end results encapsulate portfolio rationalization and re-architecture benefits improving application maintainability and end user experience.

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Medical Writing
Price on request

Abstracts

Research abstracts provide a concise description about a research project. It is typically a short summary of completed research. An abstract is used to present the preliminary results to colleagues and external society. We offer services to create a message driven scientific yet strong abstract to catch the... Show more »

Abstracts

Research abstracts provide a concise description about a research project. It is typically a short summary of completed research. An abstract is used to present the preliminary results to colleagues and external society. We offer services to create a message driven scientific yet strong abstract to catch the reader’s attention.

Clinical Papers / Journal Articles

A well conducted research is not completed unless it is supported by publishing the results in a journal/publication. We offer expert services to write quality papers according to requirements of individual journal.

Literature Reviews

A literature review is a survey or a description of published information in a particular subject area, and sometimes information in a particular subject area within a certain time period. It may be purely descriptive or may provide an assessment of a particular area of interest. We offer services by a well-qualified team to prepare structured literature reviews characterized by logical flow and relevant references.

Proof Reading

A clinical research paper containing spelling errors, grammar mistakes or ambiguous vocabulary can tarnish its image and significantly reduce chances of acceptance. Our proofreading services can identify and assist in correcting such mistakes in the content of your clinical paper. In addition to proofreading services, we will review your writings and provide recommendations for re‐phrasing content as required to ensure clarity and efficiency.

Medical Writing Services for Clinical Trials

Our team can ensure that your clinical trial documentation is always compliant with regulatory requirements and it is scientifically and medically accurate, concise and clear. Our medical writing team offers services for preparation of regulatory documents such as:

  • Study Protocols
  • Investigator Brochures
  • Clinical study reports (CSR)
  • Clinical Trial Agreement (CTA)
  • Marketing Authorization Applications
  • Scientific Reports
  • Patient safety narratives
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Clinical Data Management
Price on request
  • Data Management Plan (DMP) preparation
  • Case Report Form(CRF) Design
  • Case Report Form annotations
  • Mapping SAS variables
  • Study set‐up and configuration
  • Database programming
  • User Acceptance Testing (UAT)
  • Edit Checks Programming
  • Data Transfers from External Systems
  • Remote Data Capture (RDC)... Show more »
  • Data Management Plan (DMP) preparation
  • Case Report Form(CRF) Design
  • Case Report Form annotations
  • Mapping SAS variables
  • Study set‐up and configuration
  • Database programming
  • User Acceptance Testing (UAT)
  • Edit Checks Programming
  • Data Transfers from External Systems
  • Remote Data Capture (RDC) Implementation
  • Discrepancy Management
  • Medical Coding (MedDRA, WHODrug, etc)
  • Custom Reports
  • Serious Adverse Event (SAE) Reconciliation
  • Database administration services
  • Database Lock
  • Business Continuity Planning /Disaster Recovery planning
  • Clinical Data Management Training
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Biostatistical Analysis
Price on request
  • Preparation of Statistical Analysis Plan (SAP)
  • Randomization Design
  • T‐Tests
  • Survival Analysis
  • Kaplan‐Meier Survival Curve
  • Pearson and Spearman Correlation
  • Logistic Regression
  • Analysis of variance (ANOVA)
  • Integrated Summaries of Safety (ISS) /Integrated Summaries of Effectiveness (ISE)
  • Preparation of Statistical Analysis Plan (SAP)
  • Randomization Design
  • T‐Tests
  • Survival Analysis
  • Kaplan‐Meier Survival Curve
  • Pearson and Spearman Correlation
  • Logistic Regression
  • Analysis of variance (ANOVA)
  • Integrated Summaries of Safety (ISS) /Integrated Summaries of Effectiveness (ISE)
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Project and Process Management
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Marketing, Communication & Graphic Design Services
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Editorial and Writing Services
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Process Consulting
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Clinical Research
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Clinical Data Collection, Analysis and Management
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Equipment
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Computer Science, Software Development, and IT Services
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Engineering and Fabrication
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Computational Modeling
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Biostatistics & Bioinformatics
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