ArithmosCentrum Feature: Automated, Yet Customizable, Budget Proposal

ERP systemArithmosCentrum is a unique Enterprise Resource Planning that can manage the information flow between sales, project management, finance and resourcing, an ideal clinical system for CROs. It is a virtual office space and archive between all end-users. It was developed in-house by Arithmos to meet the needs of CROs in meeting project timelines and budget requirements.

One of ArithmosCentrum’s most attractive features is its Automatic Budget Proposal – which can reduce proposal writing time by up to 90%.

In clinical research, writing a budget proposal for a client can be a tedious and time consuming activity which can involve many team members. The sales team needs a budget proposal with input from the Project Manager and Financial Officer in a short time frame.

ArithmosCentrum allows you to produce an automatic, yet highly customized budget proposal using data entered into the system during the RFP and Project Plan stages. You can simply click a button to create a fully formatted proposal containing an executive summary, cost summary, project strategy, list of assumptions, project schedule, list of responsibilities, details of selected project team, cost breakdown, payment schedule, etc.

This automatic document creation guarantees a professional document using your own corporate layout. It will save you days of work every month allowing more time to be dedicated to sales, and less need for proposal writers.

ArithmosCentrum Overview

ArithmosCentrum manages the whole process from Proposal Request to milestone payments avoiding the need to enter the same data into different systems. Using this system, CROs can turn out budget proposals faster, efficiently manage project plans and stay on budget for all projects. CROs can also manage increased workload by forecasting the resources needed in the future. Internally, CROs can improve communication between departments to meet client specifications and timelines.

Download the ArithmosCentrum Fact Sheet.

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Arithmos Pharmacovigilance Solutions: Oracle AERS vs Argus

As an Oracle Gold Partner, Arithmos provides licenses and full support for Oracle AERS & Argus safety applications. This provides customers with web-based access to enter and report on safety data and to demonstrate complete traceability to regulatory agencies. 

Arithmos can host the system in its own data centre or install the system at a customer site – offering a full validation exercise with annual maintenance and 24/7 HelpDesk support. As an Oracle Business Process Outsoucing (BPO) provider, Arithmos can optimize safety reporting and data visualization through direct access to the safety databases or Oracle Business Intelligence (BI).

AERS vs Argus

Oracle Adverse Event Reporting System (AERS) is a comprehensive solution for product safety monitoring and compliance which provides companies with a solution to help manage adverse events and reduce risk. With its unparalleled integration with Oracle Thesaurus Management System, AERS provides companies with a solution to help manage adverse events and reduce risk.

The AERS graphical user interface provides an interactive presentation of key case information, allowing users to visualize the case elements and understand the holistic case picture. Configuration and administration is performed through the use of validated screens and end-user tools.

Meanwhile, the Argus Safety Suite is a fully integrated platform of end-to-end pharmacovigilance solutions to ensure regulatory compliance from clinical development to post-marketing surveillance. Argus is an ideal solution for managing a global workflow while providing case reports and instant safety data reports and analysis. They key functionalities are its easy-to-use interface, its system management, coding functionalities and reporting tools.

See our comparison of the two systems (click to enlarge):

Arithmos pharmacovigilance

As Oracle Gold Partners, Arithmos can support in the installation, configuration and validation of Argus for a complete pharmacovigilance solution. Due to an increased regulation on safety data and the need to improve data quality, signal detection becomes very data intensive and difficult to manage. Arithmos’ expert team can offer reporting options for real-time data access and customized reporting:

  • Access to AERS/Argus Through Oracle Business Intelligence 
  • Access to AERS/Argus data directly through application using BPO Model

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For more information on Arithmos’ pharmacovigilance solutions or our BPO partnership with Oracle, contact us at info@arithmostech.com.

Related Links

Arithmos Integrates Oracle AERS with Oracle BI

Automating Signal Detection to Efficiently Manage Clinical Data

Arithmos Develops Customizable, Low-Cost EDC System

Arithmos has developed a simple and inexpensive EDC technology platform to effectively manage clinical trials and collect patient data electronically. 

This low cost EDC solution is accessible via a Web browser using secure log-in credentials. Each clinical trial professional involved has a personalized homepage to view all assigned studies. The system can be aligned and customized to client requirements.

Arithmos’ EDC solution is ideal for smaller studies or post-market studies that require a reliable, but cost-effective, solution but also for Phase IV studies where a simple interface is needed. Pharma, biotech, medical device and academic institutions will find this an ideal tool for the collection of patient data as it has classic EDC features:

  • Electronic Data Collection from Investigator sites
  • Easy study database build
  • Integration with ePRO
  • Audit trail
  • Easy view of eCRF structure and status
  • Query management
  • SAE management

Some key product features of this system include:

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Arithmos has extensive experience in the validation and configuration of EDC systems, and the integration of various ePRO devices with EDC systems. Arithmos also provides a 24/7 HelpDesk service to manage this EDC system.

Presenting at Italian ePharma Day in Milan, Italy – 9 May 2013

Arithmos has joined the list of speakers presenting at Italian ePharma Day in Milan, Italy next month. The one day event focuses on implementing technology into clinical trial strategy and allows Italian professionals in the clinical environment share their experience and expertise.

Arithmos will be featured in the New Technology Corner to demonstrate its low-cost EDC solution for post-market studies and share a case study in which it developed CRFs based on customer requirements.

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Arithmos Joins Italian ePharma Day Speaker Lineup

Arithmos EDC services

Integrating ePRO Devices into your EDC System

The growth of EDC is driving the adoption of ePRO (Electronic Patient Recorded Outcomes) as clinical site staff are recognizing the benefits of using an integrated ePRO/EDC solution. Arithmos discusses how to integrate intuitive ePRO devices with an EDC system.

According to a survey conducted by Arithmos last year, clinical trial leaders cited immediate feedback, more accessible information and higher quality data as the main reasons for using EDC over paper. In recent years, there has been an increasing trend towards the use of electronic data capture due to its many benefits, such as:

  • Less administrative and cost-effective
  • Quicker data cleaning process, reducing Data Management costs
  • Increase of patient compliance
  • Full integration with ePRO devices
  • Real-time data so trial leaders can make more educated and adaptive decisions
  • Multi-language and global study data in a single database
  • Market shifting towards user-friendly ePRO devices
  • Devices with “apps” allow access to resources and medical information

ePRO solutions

Integration: ePRO and EDC

The integration of clinical systems puts all patient data into one system for easily accessible study results. Integrating Patient Recorded Outcomes and Case Report Forms into an EDC system produces the following benefits:

  • Reduces the risk of trial delays by eliminating discrepancies which saves time and, inevitably, cuts expenses
  • Synchronization of data to offset conflicts in two isolated datasets

Clinical trial leaders – including Monitors and Investigators – are concerned that the time required for integration will cause trial delays. However, there are Good Practice Designs and basic standards for eClinical integrations to reduce time and costs.

Integration should support data transfers in real time to eliminate the chance of outdated datasets and discrepancies, and integrated systems require a central database to store data for all trial subjects.

ePRO devices and EDC system integration requires minimal work and material. To connect the ePRO device to the EDC system, there needs to be an Internet connection such as wireless, bluetooth or plug-in as well as HTTPS on the Internet and a web server.

CDISC and the Operational Data Model (ODM) calls for XML-based formats that can accommodate all data values. Integration using industry standards is the best bet for real time views of global study progress.

integration ePRO and EDC

 

For a detailed look at ePRO devices, see our previous post “Mobile Apps and Tablets Take Over Clinical Trials”

Arithmos Experience

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Arithmos has extensive experience on the integration and validation of ePRO solutions for Oracle Clinical RDC as well as the assessment of data and patient diaries. We also have strategic partnerships with mobile and tablet experts for intuitive devices such as the iPad and Blackberry.

Arithmos has completed several EDC studies in therapeutic areas such as Respiratory, Neurology, Gynaecology, Cardiovascular, Oncology, Renal and Circulatory. In a Phase III Respiratory study with over 2000 patients in 175 sites, Arithmos integrated a spirometric device with RDC where 2 daily spirometric tests were performed and QoL diary data was collected. More recently, in a post-market dermatology study with 300 patients in 21 sites, Arithmos integrated a questionnaire on the iPad 2 to collect patient data.

Arithmos Integrates Oracle AERS with Business Intelligence; Investing in Pharmacovigilance

Arithmos has been investing in technology developments to meet the needs of the pharmacovigilance market, in particularly the need to make data more readily available. The Arithmos team recently integrated Oracle AERS and Oracle Business Intelligence to meet a specific need in the pharmacovigilance market: to provide a user-friendly platform that allows real-time access to structured data. As an Oracle Business Process Outsourcing Provider, Arithmos can use and understand Oracle applications to offer a premium value package to its clients.

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Defining the Need

The Oracle AERS and Business Intelligence integration is an investment in outsourced pharmacovigilance work which requires the need to access real time data and results. The current process involves an Oracle9i database and periodical reporting through SAS which publishes reports in a web page. However, the data is not always available in real time, therefore Arithmos has identified the following user requirements:

  • Accessibility to live data anytime, anywhere in accordance with regulatory requirements
  • Aggregated data: the ability to navigate, modify and interact with results
  • A flexible platform and an easy-to-use interface

Arithmos’ Solution

pharmacovigilance technologyThe proposed solution by Arithmos is an integration of the Oracle9i database with Oracle Business Intelligence Standard One edition which creates an Oracle interactive dashboard that allows companies to constantly access data and results.

The implementation process requires building a Business Intelligence repository, analyzing data and publishing data on the Dashboard. An ODBC connection is required to import Oracle AERS data into an Oracle BI repository where there are 3 layers: Presentation Object, Logical Business Model and Physical Data Sources.

The Oracle BI Dashboard management allows customization of paye layout according to user requirements. A web interface allows access to the “Answer” section where queries, charts and format views can be created. The Dashboard is interactive, which allows companies to access live data corresponding to user requirements.

Why invest in Pharmacovigilance?

The pharmacovigilance market is expected to grow to $2.2 billion USD by 2015, according to a Frost & Sullivan report (World Pharmacovigilance Markets in Lifesciences). The FDA adnd EMA have increased regulations on drug safety, and in an effort to cut costs, pharmaceutical companies are outsourcing drug safety work.

A burdening cost for most companies is technology and the migration of data from one system to another. The pharmacovigilance market will benefit from system integration that provides readily available data and results.

Arithmos and Pharmacovigilance

oracle-gold-partner-logoAs an Oracle Gold Partner and BPO partner, Arithmos can provide the licensing for Oracle AERS and Oracle Business Intelligence and take care of the implementation and integration. A Business Intelligence licensing solution is recommended for companies in which:

  • Staff is not familiar with database navigation
  • Real time and constant access to data is necessary
  • In-depth data analysis is necessary

Related Links

Arithmos Pharmacovigilance Services

Arithmos Solutions – AERS vs Argus

Automating Signal Detection to Efficiently Manage Safety Data