Documentation

ARITHMOS has given a series of presentations throughout the year and has started writing articles on various topics in life science technology. Below find some examples and the presentation abstracts, and if you would like further information, including a copy of the presentation, please contact us at info@arithmos.it.

From ePRO to iPRO: the effects of the iPad on adherence and clinical trials
AUTHOR: MARY WIEDER, MARKETING OFFICER
One of the fastest growing segments of the electronic clinical trial market is electronic patient-recorded outcomes (ePROs.)
The adoption of electronic clinical trial technology has grown rapidly as clinical trial leaders discover new ways to streamline the drug development process.
As patient-recorded outcomes (PROs) move from a paper to an electronic platform, new devices are available for recording patient data.
These new devices can increase trial efficiency as well as patient compliance.
As this market continues to grow, it is important to know which ePRO devices can best serve clinical trial needs. (For more on trial recruitment, see Social media: A tool for clinical trial recruitment?)
While some clinical trials are still conducted using paper PROs (or even a hybrid model), switching to ePRO can save money and produce better quality data.
Another added benefit to ePRO is patient preference. According to the Drug Information Journal, 88 percent of patients-as well as 91 percent of clinical staff-prefer ePRO to paper.
Therefore, it is no surprise that patient compliance increases significantly with ePRO solutions, up to approximately 90 percent as compared to 30 percent with paper.

From ePRO to iPRO

The next question is how to electronically collect patient data. The Web is an ideal tool.
However, new technological devices-such as laptops, smartphones and iPads-may be a better bet.
Using a Web-based solution, clinical trial leaders risk losing data or patient compliance if the Internet does not work properly, or if the patient is distracted by external factors.
Devices, on the other hand, can be provided individually to each patient.
Devices also allow the questionnaire to appear in the same format for each patient.
Therefore, which devices are the best for collecting patient data electronically?
Netbooks and laptops are ideal for patient compliance because of their large screens, which can display multiple questions and responses.
The data is then submitted automatically, eliminating any burden on the patient.
Smartphones only further increase patient compliance by being easy to use with no assembly necessary. (For more on smartphones, see When does a smartphone become a medical device?)
Data is also transmitted automatically to allow for real-time management of a trial. (For eyeforpharma's series on iPads and pharma, see Future pharma: Making the most of the tablet takeover, Future Pharma: A closer look at the iPad in pharma/physician relations, Pharma goes mobile: Making the most of the app opportunity and Will the iPad kickstart a pharma sales and marketing revolution?)
However, is the ePRO market now looking to go iPRO?
The iPad could be the ideal device for real-time clinical trial management.
Not only can the iPad submit data automatically, it is an ideal device for patient compliance.
The iPad has the look and feel of using paper, which could be comfortable yet convenient for patients.
Additionally, the iPad offers apps that can download medical studies and clinical trial information that may be useful to the current trial.
iPads with 3G capabilities can allow clinical trial leaders to also interact with patients in real time, reminding them of scheduled visits or monitoring medication intake.

Oracle AERS Integration with Oracle Business Intelligence
AUTHOR: Silvia Gabanti, Head of Health Science Services and Helpdesk
Pharmaceutical companies are looking for greater operational flexibility, efficacy and cost reduction. The ability to provide timely access to clinical data and take advantage of available information enables companies to drive their programs and related activities more efficiently.
Consequently the interests of the companies are more and more oriented to Business Intelligence applications with the aim to take advantage of new opportunities by exploiting information coming from the operational databases. In the Health Science Application this trend is explored by Oracle with the CDA (Clinical Development Analytics).
However, in some cases, a more dynamic solution to satisfy any requirement of the end user may be preferable.
In this presentation we show a case study about the integration of Oracle Business Intelligence SE1 with Oracle AERS. The case presented regards a company that has outsourced the pharmacovigilance service.
If BPO licensing is preferable in most cases, choosing a Business Intelligence solution may be recommended in cases where the company staff:
- is not familiar in database navigation
- does not need to access to all system features available
- needs constant access to data in real time
- is interested in deepening the data analysis.

From these considerations the choice of integration between Oracle Business Intelligence and AERS aims to provide a platform that allows access to structured data in an easily accessible and familiar way.

In this presentation, a case study will be described, by covering the following points:
- Customer Needs
- The proposed solution
- The implementation process
- Advantages and feedback

Accessing study data with Oracle Business Intelligence on iPad and iPhone
AUTHOR: Gianluigi Albertini, IT Manager and Systems Analyst
The need for accessing study data from portable devices is increasing day by day. Customized reports represent an effective way of monitoring the study conduction and should be available easily. Oracle is catching up in the area of the mobile Business Intelligence by introducing "apps" for I-Phone and I-Pad to access Business Intelligence applications. In this way, customized reports can be implemented in Oracle Business intelligence and made available with no effort from the final users. Furthermore, users can be provided with a ready-to-go device configured as a kiosk with the sole capability of accessing the study reports. With this effective way of accessing information, clinical study managers and sponsors can proactively monitor the study conduction with no geographic and time limitations.

GLOBAL SURVEY RESULTS: ANALYSIS OF ELECTRONIC DATA CAPTURE USE IN CLINICAL TRIALS
AUTHOR: MARY WIEDER, MARKETING OFFICER
Starting in May 2011, ARITHMOS launched an international survey to collect and analyze data on the use of Electronic Data Capture (EDC) in clinical trials. ARITHMOS, an information technology company serving primarily the pharmaceutical industry, provides Oracle RDC implementation and hosting for clinical trials and created this survey to better understand the EDC market in general and to learn how to provide better EDC services to its clients. The objective of this survey was to obtain a global perspective on:

- EDC use among different job roles
- the advantages of using EDC
- the barriers to EDC implementation and use and how to overcome them.

ARITHMOS has collected 144 responses from over 20 countries.

ePRO and eCRF INTEGRATION: A CASE STUDY
STEFANO PICCOLI, CHIEF OPERATING OFFICER
The adoption of electronic clinical trial technology has grown rapidly as clinical trial leaders discover new ways to streamline the drug development process.
However, new technological devices-such as laptops, smartphones and iPads-may be a better bet.
This presentation focuses on:
- An introduction to the ePRO market and how it has evolved in just the last few years
- An introduction to the integration of ePRO and EDC systems and why it is important
- An evaluation of the devices available for ePRO and those that can integrate with EDC systems - for example Blackberry, iPhone and the iPad.
- How devices are increasing patient compliance
- Why doctors and Investigators are keen to the iPad
- A case study of how ARITHMOS has successfully integrated ePRO devices and EDC systems