Leveraging Cloud Technology in Pharmacovigilance

healthcare-cloudThis month ARITHMOS hosted its first Pharmacovigilance Day seminar in Milan, Italy. The event focused on modern technology solutions to meet the challenges of pharmacovigilance and collecting patient safety data. Gianluigi Albertini of Arithmos gave a presentation on the cloud computing technology as a solution for pharmacovigilance and discussed how leveraging cloud computing can be an effective and cost-effective solution.

The National Institute of Standards Technology (NIST) defines cloud computing as follows: “Cloud Computing is a model on-demand network access to a shared pool of configurable computing resources (e.g. networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal management effort or service provider interaction”.

As a user, this means a company can access services from anywhere via the Internet without hardware/software provisions, installing service applications, maintaining and updating applications or disaster recovery. Resources can be assigned and configured to meet customer usage requirements in terms of functionalities and computer needs. In terms of resource optimization, business investment is better aligned with the service and guarantees a better Return on Investment (ROI).

In terms of time, cloud computing minimizes the time to delivery. Customers should be independent of the service provider in terms of application management which reduces maintenance time.

Pharmacovigilance Systems in the Cloud

edc1Pharmacovigilance applications should be accessed through the internet with minimal IT effort through web browsers with no installation required on a PC. Another option is to publish the application in Citrix with only a plugin to install.

To implement a cloud-based pharmacovigilance system, the application is deployed with a standard validation configuration with changes being applied to meet customer business processes and needs. The changes can be tested before the application is released into production.

Examples of pharmacovigilance systems in the cloud are Oracle AERS and Oracle Argus. Oracle AERS is a cost-effective and ready-to-use solution for managing Adverse Events from capture to reporting. Oracle Argus is a more comprehensive system with configurable workflow, advanced query and reporting functionalities, case import/export and document management.

However, Oracle AERS is not a Software as a Service (SaaS) system. It was developed to be used by personnel within the company LAN. External users cannot connect via VPN to the LAN, and the VPN is not always a stable connection. The best solution would be to publish AERS in Citrix with the plugin installation in order to reduce bandwidth usage.

Oracle Argus, on the other hand, is a native SaaS solution which can be accessed via web browser. After configuration and release, customers can use the application with minimal interaction using the service provider for maintenance.

Oracle AERS has been configured and validated according to a standard pharmacovigilance workflow. Reduced configuration and testing activities accelerate the system deployment with a cost-effective solution, and hosting and maintenance are regularly performed. Regardless of the system used, AERS or Argus, customized reports can be added to the default reporting capabilities of the application. Reports are created by the service provider and accessed via web portals from anywhere.

A cloud computing and SaaS solution is a valuable technological trend for efficient application delivery. The burden on the customer is reduced in terms of hosting and maintenance and the default configuration meets standard business processes. This solution is flexible to changing business and operational needs and guarantees an efficient and cost-effective solution.


ARITHMOS Hosts Successful Pharmacovigilance Day Seminar in Milan

arithmosOn the 12th of November, ARITHMOS hosted the first annual Pharmacovigilance Day seminar at Hotel Melia in Milan, Italy. The event, supported by Oracle Corporation, was born to discuss changes taking place in the pharmacovigilance environment, including new and and updated legislation by the European Union, and to present new and improved technology solutions to enhance pharmacovigilance management.

ARITHMOS put together a team of expert panel speakers to discuss pharmacovigilance safety databases, data migration, signal detection and regulatory compliance for pharmaceutical, biotechnology and medical device companies as well as CROs of any size. The reality is that many companies, especially of small to mid-size dimension, struggle to implement effective pharmacovigilance processes that both comply with regulations and improve efficiency while keeping costs under control.

Paolo Morelli, ARITHMOS CEO, introduced and moderated the event.

Panel speakers Robbert Van Manen of Oracle and Mike Roberts of Pink Octopus Consulting addressed new pharmacovigilance legislation. Robbert presented the EU’s GVP Module IX on Signal Management and how its requirements can be met with the current release of Oracle Empirica Signal and Topics. Meanwhile, Mike discussed the migration of a pharmacovigilance system to Argus Safety in order to comply with international regulatory standards, improve quality and data standards and positively impact productivity.

Marco Bulleri, representing Abiogen Pharma S.p.A., presented a case study on implementing an Oracle BPO (Business Process Outsourcing) solution for small to mid-size pharmaceutical companies. The case study demonstrated how Abiogen utilized this solution for the collection of safety data coming from both clinical trials and post-market surveillance and the support received by ARITHMOS in migrating and implementing the new AERS system.

healthcare-cloudRounding out the expert panel was the team of Gianluigi Albertini and Stefano Piccoli of ARITHMOS who did presentations on cloud technology. The presentations captured both a solution for pharmacovigilance and the adoption of technology trends in the healthcare field. Starting from the definition of “cloud” and SaaS (Software as a Service), Gianluigi demonstrated how current PhV systems such as Oracle AERS and Argus can be delivered as a SaaS solution. In the second presentation, Stefano covered compliance in the cloud including computer system validation solutions.

The seminar, which was conducted in dual language (Italian and English) and free for participants, received positive feedback from all attendees. Overall, participants found the seminar informative and useful for current pharmacovigilance needs and appreciated the chance to discuss and debate these issues in a professional environment.

The event concluded with a cocktail reception offered by ARITHMOS for all attendees.

ARITHMOS is planning to hold the event again in 2014 and add additional seminars on healthcare technology topics.

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EDC Use on the Rise Despite Technology Implementation Concerns: an Overview

smart doctorThe global e-Clinical trial technology market is expected to reach $1.37 billion USD by 2018. Currently around 15% of newly initiated trials are using technology. Electronic Data Capture (EDC) is the fastest growing technology being adapted in the clinical trial environment despite concerns over efficiency. ARITHMOS discusses overcoming these concerns and why Sponsors should evaluate EDC options for their next study.

The United States and Western Europe have generally been the largest adopters of EDC technology. The U.S. eClinical trial technology market alone is growing 23% annually. The market is also shifting towards other geographical locations which can provide low cost, efficient solutions.

The main driver for adopting technology is the pressure on pharma, biotech and medical device companies to improve productivity, accelerate the drug development process and, of course, cut costs. There is an increasing number of clinical resources passing from preclinical to clinical trial phases, and study leaders need to be able to validate and analyze data in real-time in order to make crucial decisions.

Despite the numerous benefits – such as increased patient compliance, quicker data cleaning and real-time data – clinical trial leaders are still hesitant to adopt EDC technology. Many fear there is an added workload including double data entry, EDC edit check and technological implications. Clinical trial leaders believe that technical problems, such as complications with the actual system of lack of training and knowledge, can lead to time consuming activity.

The scope of EDC can also include the integration of an ePRO device. Another barrier to EDC/ePRO use has been the intuitiveness of devices used. While most people are comfortable using PCs, fax machines, scanners and email, many incorporating new devices such as smartphones and tablets can be challenging and require training and a different mindset.

Despite concerns, why should Sponsors still evaluate EDC solutions for future studies?

LearnThe availability of integrated data can enhance the overall drug development process through greater efficiency and effective decision-making. With adequate training and HelpDesk resources to provide continuous technical support, Sponsors should feel at ease implementing EDC technology. The main benefits include:

1. Immediate Feedback: Sponsors can resolve discrepancies faster and reduce time and costs with immediate feedback from patients. Data can be transferred in real time during the study into the eCRF. Query management is accelerated, and any inconsistencies in CRF or ePRO data can be checked in real time.

2. More Accessible Trial Information: An EDC solution can organize multi-language, global study data into a single database. Biostatisticians can receive up-to-date study metrics and statistical reports can be carried out in the short term with low risk of data blinding errors.

3. Higher Data Quality: Data is stored in an encrypted mode preventing data from being changed, deleted or modified. The data cleaning process is faster with Alert and Query Managers and edit and discrepancy checks are automated.

ARITHMOS also knows that one EDC system does not fit all studies. EDC selection can vary based on study phase, therapeutic area, patient enrollment and budget. Consult Arithmos for your next study to decide which EDC system or EDC/ePRO integration solution is best for your study.