The Launch of our Expanded Solution for Clinical Study Management

Whether I’m talking to sponsors or sites, everyone is pained by the mountains of paper that accumulate as a result of clinical trials. Related to this, they are frustrated by the amount of repetitive and redundant manual work caused by all the paper.


16 November 2010

Today is a special day for me. Not only does it mark my five-year anniversary with Intralinks, it also marks the launch of our expanded solution for clinical study management. Since joining Intralinks in 2005, I have built relationships with our life sciences client base and the expansive community who use Intralinks every day to manage their clinical trial work. From heads of clinical operations and study start-up managers at pharmaceutical companies and contract research organizations (CROs), to principal investigators and study coordinators at investigative sites, I have had the invaluable opportunity of hearing first-hand what drives these individuals, what keeps them up at night and what they would like to have to make their life easier. To a product marketer, this kind of direct market insight is pure gold because it’s the kind of information that drives innovation to ensure product relevance, value and distinction.

Whether I’m talking to sponsors or sites, everyone is pained by the mountains of paper that accumulate as a result of clinical trials. Related to this, they are frustrated by the amount of repetitive and redundant manual work caused by all the paper. In addition to the anecdotal evidence, this message has come through loud and clear in primary market research we’ve conducted. For instance, in a recent study we conducted, when asked, “What are your top three frustrations with your current clinical trial process?” sites answered — 1) the amount of paper, 2) delays due to slow/incomplete communication, and 3) redundant paperwork.

While Intralinks has been helping the industry get out from under the heavy load of paper by providing a secure, online platform for the organization and exchange of study-related documents between sponsors, sites and IRBs for over a decade, our new release takes our solution to a new level. In direct response to the needs of the industry, we have added sophisticated capabilities to elevate process standardization and automation and improve the ability to monitor activity and take action to ensure key milestones are hit.

For instance, with our new release, clients can configure business processes and intelligently identify people and documents, so workflow can be automatically triggered based on activity. For example, when a new site is added to a study on Intralinks, the system can automatically generate a “task list” with all of the study start-up documents they need to reference, complete or submit and assign the task list to the site. That means the site can immediately begin completing the study start-up package for faster activation. Workflow can also be established to automate certain processes on the sponsor-side when a document is received, such as review and approval. Finally, document expiration dates can be established so that alerts and tasks can automatically be generated when a document needs to be updated, such as a medical license, ensuring that essential regulatory documents are always up-to-date.

Another new feature delivered in this release is real-time dashboards that allow you to monitor progress at any time and hone follow-up activities to efficiently keep your study on-track. These dashboards provide different views of task status & progress based on what’s important to you — by process (i.e., study start-up), by study or by group (sites, regions, etc.). The dashboards allow you to drill into detail such as percentage complete, open tasks, days open, etc.

These are just a couple of examples of what clients are now able to do with Intralinks. The return on investment of our solution for study management is measurable. Pharmaceutical companies and CROs will save time by reducing cycle time and having instant access to critical documents, information and process status; save money by eliminating the need for overnight mail, reducing man hours associated with manual site management processes, and avoiding internal IT costs for system maintenance and support; and, reduce risk by ensuring security and control around site communication and document exchange, elevating SOP adherence and improving compliance reporting detail.

Today is special to me, but I would say it is also special for the life sciences industry... the document-centric processes related to study management just got a whole lot easier! Contact an Intralinks sales representative to get a demo and see these new capabilities in action.