New Generation of Software for More Efficient Clinical Trials and Multicentre Projects

Beside the software, IT provider will usually provide tailor made adjustment of software and IT support during project. Application will be a user-friendly, scalable and secure. It will run form any PC configuration and any standard operating system. Project data will be accessible from any computer with Internet connection and much, much more …..

Samobor, Croatia, 22th August  , 2006: With more than 1,000 CROs already operating worldwide, 260 in North America, 460 in Europe and the rest mainly in South America and Asia, and with cost as the primary driver in this business, CRO world development  is set to continue.

Contract drug development spending reached $19bn in 2005 and will increase at an annual rate of 17 per cent to exceed $42bn by 2010, according to a new report by Kalorama Information, publishing division of MarketResearch.com.

Global drug development spending will top $105bn (€81.5bn) by 2010 and 40 per cent of this business is expected to be dished out in outsourcing contracts – with contract research organisations (CROs) emerging triumphant.

Outsourcing will only continue to expand as pharma and biotech companies come to rely on these services to cover gaps in their own capacity, increase their skills base, and bring drugs to market more efficiently. Use of advanced information technologies is crucial for achievement of higher efficiency.

Most research takes place in different centres simultaneously. These are often located in different cities or even in different countries. It is required to prepare and distribute/dispatch all the materials - protocols, forms, etc to all the centres. Later, it is required to gather all the forms, ensure that the data is valid and prepare the data for statistical analysis. As it sounds, this process seems rather simple and straightforward. Experts in the field of clinical trials know that it is not as simple as it sounds. The situation can become more complex if some data is missing or is not provided in appropriate form, if numerical values are out of range, if data are inconsistent, etc.

Many of those problems can be solved with IT solutions for clinical trials and the rest can significantly benefit from it. There are two approaches in providing IT solution for clinical trials – classic application and Web based solution.

Classic application, almost 100% of them Microsoft Windows based, is an out-of the- box solution that needs to be installed on every computer that will be used in the process of collecting the data. Users simply install the application from the CD and start working. This is how it would be described in the advertising materials of such application, but in reality there could be many problems. Levels of computer skills are different from person to person. So, some of them might require assistance while installing the software. Many computers that are present in centres might not meet the minimal hardware requirements. IT security policies in clinics might be an issue for the installation of software. On the other hand, there is still the issue of dispatching – not the papers, but the application!

A Web based solution is the other approach. It does not require installation of any kind of software - only a web browser is required. All computers running Microsoft Windows have web browser readily available. For all other computers, it is very likely that it is already installed and if not, it’s available free of charge. The application and the database reside on the central application server. All the users access the central server. This actually means that any computer connected to the Internet can be used for data entry. One of the key benefits is that the maintenance of the application and the database is centralized. Data backup, security management, virus protection and operating system upgrades can be handled by trained personnel at one centralized location only. It is not required to distribute neither software nor paper materials – sending the URL of the application is all that is required. Users are not required to have any specific computer skills aside from knowing how to use Internet. In general, Web based application usually offers many advantages compared to traditional methods of gathering data via paper forms or classic applications.

One example of web based solution developed by member of Farmavita.Net could be downloaded as pdf file Clinical Trials Software at http://www.farmavita.net/media/Clinicaltrialssoftware.pdf Framavita.Net (www.farmavita.net)  is network for development and licensing of new pharmaceutical products/technologies.

So if you are looking for ways for efficiency improvement then beside the software, you should look for IT provider who will provide tailor made adjustment of software and cost effective IT support during project. Application should l be a user-friendly, scalable and secure. It should will run form any PC configuration and any standard operating system and  much, much more …..

Software and IT support is available from member of Farmavia.Net. Please conatact us for more details.

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