Guidance and Technology: A Single-Source Solution Rick Piazza, VP, Product Strategy In today’s technology-reliant clinical-trial studies, it is crucial that software providers maintain a staff of in-house experts to offer counsel and guidance to sponsors. These experts act as process partners to help sponsors determine which technologies and safety protocols best enable each particular clinical trial, as well as how to use these solutions to maximize results. This consultative portion of the overall process not only educates sponsors about the flexibility and adaptability of e-clinical tools, but it also gives sponsors insights into the cost savings associated with electronic reporting. With the vast amount of clinical-trial service providers available in the industry, sponsors are tasked with the challenge of selecting the most appropriate and reliable provider. To do this, there are a number of factors to consider. Expert Guidance E-clinical software vendors are discovering, or will soon discover, that they are responsible for the training and education of those involved in the management and administration of clinical trials. Although progression has been slow, adoption rates of e-clinical technology are steadily increasing as people become more comfortable with software and as the inefficiencies of paper reporting are exposed. Vendors are finding it necessary to take the time to consult with clinical-trial sponsors to determine which tools are best suited for a particular trial and what demographics to consider when designing the trial. Those vendors that lack this informative and consultative piece are beginning to fall behind the leading software and service providers. Software Capabilities The industry and, more importantly, clinical-trial sponsors are recognizing that e-clinical technology solutions provide real- and near-real time data analysis and allow for a quicker response to serious adverse events. This ultimately allows for more accurate and timely data to be submitted and transferred to a central database much quicker than paper reporting allows for. Technology solutions providers can enable the test design process by providing customers with an integrated, single-source platform of data reporting tools and devices. Today’s trial sponsors and investigators are contemplating the removal of paper reporting processes as they begin to understand and become more comfortable with e-clinical technologies. Over time, a single-source provider that can consistently offer flexibility and simplicity in its technology will lead the industry. Service + Software = Solution Clinical-trial sponsors may find it a somewhat straightforward task to identify quality technology solutions and expert service teams, but finding the proper combination of such technology and service solutions can be daunting. Nevertheless, it is vital in order to find the most effective solution. Customer service, training, knowledge sharing, education, technical support, and overall industry expertise often have major impacts on the drug-development process. Many companies and sponsors overlook the importance of these factors, but leading vendors focus strategically on how to best serve and support clients and how to most successfully ease any concerns that may arise throughout the duration of the trial. Although solutions providers may have broad in-house resources that include experience and industry knowledge, the client won’t truly benefit unless the company can effectively service them with this information and assist them on a consistent and continual basis. Asking the provider to offer a demonstration of the technology during the sales process will expose clinical-trial sponsors to the full e-clinical solution, and enable them to find the best combination of technology and service. Sponsors can then select a single-source provider that offers user-friendly technology and streamlines the clinical-trial process most effectively and efficiently. Although solutions providers may have broad in-house resources that include experience and industry knowledge, the client won’t truly benefit unless the company can effectively service them with this information and assist them on a consistent and continual basis. etrials Worldwide inc., Morrisville, N.C., is an e-clinical software and services company dedicated to enabling pharmaceutical, biotechnology, and contract research organizations to bring new drugs to market faster and more efficiently. For more information, visit etrials.com. June 2007 VIEW on Clinical Services

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