Exploring the New Face of Web-based Investigator Portals


The Center for Business Intelligence held its inaugural conference on clinical trial investigator portals in Philadelphia, PA this past November. The well-attended event focused on helping attendees make informed decisions on implementation and adoption of clinical trial portals.

Panelists and presenters provided insight on clinical portals today to 74 attendees, discussing the pros, cons and key points on successfully implementing clinical trial portals.

Web-based portals have been used in the life sciences industry for most of the decade, however the widespread adoption of the investigator portal has been slow.

“Many of the early investigator portals were not implemented successfully because they were not developed with the needs and skills of the end user (i.e. the investigator and his/her site staff) in mind as a top priority,” Diane Nedelkoff, Director, Clinical and Investigator Portal Solutions, InnovoCommerce, told Applied Clinical Trials.

Nedelkoff was excited to be a part of the inaugural conference, as she possessed one of the more unique perspectives in the room. After working at Pfizer for 17 years where she was responsible for building the Pfizer portal, Nedelkoff is now employed by a vendor that creates web portals for the pharmaceutical industry.

Nedelkoff spoke at the conference encouraging attendees to survey investigators and clinical end users to optimize portal design. “A portal development team must carefully consider the technical knowledge and comfort level of the end user when choosing a platform on which to develop the portal solution,” said Nedelkoff.

She advised attendees to use a questionnaire to understand what their end users really want before designing something. “If the solution is not intuitive in its navigation, engaging in content and easy to access, the end users will not commit to its use as the primary communication tool, opting instead for more traditional communication methods,” said Nedelkoff.

She surveyed hundreds of investigators from around the world representing major research facilities, hospitals and private practices, and reported these findings to the audience.

Attendee Michael Agard, clinical operations manager Sanofi-Aventis said investigator portals will help to increase collaboration both internally and with their customers. He believes clinical trial portals can expedite processes, improve quality and reduce costs of administrative tasks associated with document management.

Sanofi-Aventis uses portals for most of their Phase I studies and one for selected safety information. The company is planning on a major portal project deployment in 2010 for their Phase II – III studies.

“It was interesting to see the portal evolution from different perspectives of document management, training and safety. However, we all have similar goals and hurdles,“ said Agard.

Presenters gave specific case studies to provide the audience with examples of successful portal implementation. Agard’s favorite presentations at the conference included learning about what Bristol-Myers Squibb and the Department of Veteran Affairs did with their portals.

Presenters also addressed the issue of security of clinical portals as it is a concern for attendees.

“Security is the most important consideration for sponsor companies electing to use a portal as its primary communication tool with external partners,” said Nedelkoff.

IT Quality Assurance representatives from the sponsor companies are most concerned about maintaining the security and integrity of the GCP documents as well as the confidentiality of any personally identifiable information that may be surfaced on the portal, said Nedelkoff.

Read-only access is typically given to internal colleagues or company representatives from clinical research that have been appropriately trained on corporate data handling and the confidentiality of proprietary information. System administrator and content management access is given to authorized internal users who have responsibility for the user/account management and the content of the portal.

“I think in the future, it would be interesting to get the customer perspective from site personnel regarding their thought about portal usage,” said Agard.

The adoption of clinical trial portals is a progressing topic within the industry. The goal of the conference was to provide attendees with the knowledge to make informed decisions and implement successful web-based portals.

Based on the success of the event, CBI is planning to host it again May 20-21, 2010 in Philadelphia.

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