ARITHMOS Launches Survey on Pharmacovigilance Market & Challenges

In an effort to better understand the complicated, yet growing, pharmacovigilance market, ARITHMOS has launched a survey on present challenges facing pharmacovigilance professionals.


This market survey aims to meet two key objectives:

– Understand the most pressing issues pharmacovigilance professionals face in terms of safety systems, inspection readiness and reporting
– Understand expectations in terms of financial investment in safety systems and what constitutes a good Return on Investment

The ARITHMOS pharmacovigilance survey is intended for market research purposes only and should take approximately 10-15 minutes to complete.



Cloud-Based EDC Part 1: 10 Reasons to Consider a Cloud-Based EDC System

cloud-based EDCThe pharmaceutical industry has already been using cloud computing primarily for research purposes. It has been estimated that cloud computing techniques could lead to a 30 percent increase in speed to trial for clinical work, resulting in up to $400 million USD in savings.

If the market continues to adopt EDC/ePRO technologies, paper studies and subject diaries may no longer exist in 10 years or less.

Electronic Data Capture (EDC) has been one of the technologies frequently adapted to cloud-computing for clinical research. In this two-part blog, ARITHMOS will first list 10 reasons to consider a cloud-based approach to electronic data collection, analysis and reporting. In Part two, we will discuss how to implement a cloud-based EDC system.

10 Reasons to Implement Cloud-Based EDC

1. No more hardware/software installation

According to recent industry reports on cloud computing, computer systems can cost a company up to $2 million USD plus the additional costs for experts to install and maintain these systems. The Cloud eliminates the need for hardware and software installation and allows clinical applications such as to be accessed through a web browser with personal credentials. Additionally, a cloud computing solution eliminates the need for IT infrastructure such as data centers, significantly reducing costs.

2. Pay on a Per Study or Per Functionality Basis

With no hardware/software installation or IT infrastructure investment and no need for an expert consultancy team, the Cloud allows users to pay per study, or in some cases, by functionality used. This can result in huge cost savings for companies on a tight budget.

3. Risk-Based, Remote Monitoring

It is encouraged by regulatory authorities and Cloud based EDC allows for real time data collection and immediate analysis and reporting from various devices, anywhere there is a connection.

4. Mitigate Risk

The Cloud makes it easy to collect and transfer data into one database for quick and accurate analysis. Using HTTPS connection and various security measures, companies can ensure secure and private data transfers. Avoiding hardware/software installation also means fewer technical problems to deal with as a company, and therefore the company can focus on trial conduct and not technology issues.

5. Faster Trials

Cloud-based data delivery and management is a surefire formula for speedier clinical trials and makes proof of concept testing faster and easier.

6. More Efficient Data Management and Better Data Quality

Resolve discrepancies faster and reduce time and costs with immediate feedback from patients; Data can be transferred in real time during the study and query management is accelerated.

Ensure automated edit and discrepancy checks, faster data cleaning, audit trails and compliance with GCP and regulatory guidelines.

7. Better Global Study Program Organization

Organize multi-language, global study data into a single database; this is especially beneficial to statisticians who need up-to-date study metrics in other parts of the world.

8. Convenience of Software Reusability

With the cloud, it is possible to use the same software application for various studies which is very convenient for study sponsors. Sponsors can save time and effort on training since all data will be in one database and there is only one system to learn.

Cloud-based EDC is also more convenient for an RBM approach making it easier to analyze data across different studies.

9. Reduce training time and costs

Training efforts are kept to a minimum because of high usability and the ability to implement cloud-based eLearning solutions for EDC systems. This reduces training logistical costs for companies on strict budget requirements.

cloud10. Considerable Cost Savings

All of these above-mentioned factors lead up to the main selection driver for most companies: COST. The elimination of hardware/software and the associated consultancy, quicker and more efficient trials and better management all result in considerable cost savings.


Related Links

ARITHMOS Cloud Implementation Services
Symphony EDC