IntraLinks expands Workspace capabilities to speed clinical trials

According Richard Jenkins, General Manager of Life Sciences at IntraLinks, the hub also enables a more efficient exchange of information in clinical trials.



According Richard Jenkins, General Manager of Life Sciences at IntraLinks, the hub also enables a more efficient exchange of information in clinical trials.

The drug development hub is designed to accelerate the clinical trail process by improving the information exchange of any trial, Jenkins said. The center of gravity for this business process, sits outside of pharma and outside of any of the organizations involved. The people involved in the business processes are the pharmaceutical companies, the CRO, the IRB's, the investigators, and the FDA and the movement of information between all of those parties is outside of any one of them.

By having a hub that is aligned directly to their requirements, the external users are free to exchange information with any of the other organizations involved, he continued. Everyone has many-to-many exchanges that they need to carry out and so having a hub makes economical sense, but more importantly, you'sre not asking people to change their business processes. The drug development hub helps to speed the clinical trial by improving the information exchange between participants in the trail.

One new feature of the hub is Investigator Meetings. IntraLinks's digital workspaces are designed to provide multimedia capabilities, including audio, video and slides for investigator meetings. Instead of traveling to remote meeting locations, potential investigators can view meeting presentations online, thereby eliminating travel costs and time. Information also can be reviewed as needed, and any investigator joining a trial in progress can be brought up to speed immediately. According to Jenkins, it's an important addition to functionality, especially when clinical trials can be an extremely lengthy process.

Many times, the trial doesn'st start until long after the initial meeting, so this capability enables investigators to go back and refresh on the information discussed, Jenkins said. For new investigators, it means they are able to go in and access information regarding the trial in one place. Today, investigators can attend live meetings and show the pharma company what they used for their meeting content.

And, Jenkins said, the benefits are there for sponsors, too.

For sponsors, it reduces the cost and enables them to reach a much broader audience, he said. It also enables them to certify the comprehension of the training and meeting of participants immediately online.

In addition, the IntraLinks drug development hub also can be used for training and certification. With the expanded functionality, the digital workspaces can now be used to certify investigators in areas such as Good Clinical Practice. After viewing a presentation online, potential investigators can be tested on the content and the system's reporting functions let clinical trial managers monitor who has completed training sessions.

In addition, IntraLinks can create customized testing modules for use in online training. Tests are self-administered through the secure workspace environment, and results are available immediately. Trial managers can view reports of results for all test-takers, and individual investigators can see their results.

Despite its new capabilities, Jenkins said the drug development hub is not designed to replace the role of trial managers.

Trial managers are still responsible for collecting the content from investigators, Jenkins said. What this capability provides is a much better distribution and reporting of that content. Now the content includes all of the information about that trial, all the interactivity on that trial and all the documentation. It is a validated platform that is 21CRF Part 11 compliant and is a neutral 3rd party standard.

While aiding in the distribution of content related to clinical trials, the hub also enables cost savings in both the distribution and collection of information.

The way the process used to work is that upon a clinical trial start up, the pharma company had to distribute the regulatory package, Jenkins explained. So in a phase II or phase III trial, pharmas send out hundreds of these packs, the investigators then receive those packages, take information from them and send some of that information to the IRB's. Then the information has to be collected. Now, many times, this whole distribution and collection of information could be done electronically, so using this system you cut down on the distribution and collection costs. If you can cut out the distribution cost and time, you save money and time. We have introduced a new analytical tool that has quantified savings at several pharmas, and it ranges from 30% - 50% time-savings as well as hard cost savings.

Aventis is already using the new functionality to accelerate the speed of its drug development process and reduce expenses.

"IntraLinks' new capabilities have enabled us to transform our processes for investigator meetings by completing the training and testing of physicians online," said Robin Kelen, RN Medical Product Manager with US Medical Research at Aventis. "We have been able to reach out to a greater number of potential investigator sites, while reducing the number of investigator meetings and increasing flexibility and convenience for physicians."

The Aventis project has been very successful, Jenkins said. They had a goal of rolling this out very quickly and we were able to roll it out in less than a month. The objective was to get one-third of the potential investigators to use the online service. We were able to scale and have over four hundred study recruits elect to participate.

According to Jenkins, by identifying challenges within the system early, IntraLinks has been able to avoid any major stumbling blocks.

So far it has run pretty smoothly, we have conducted over 60 clinical trials on the system, and because of our experience, we pretty much know where the notches occur, he said. We know the challenges investigators face, we know they work pretty much 24/7, so we have a round-the-clock live help desk that investigators can call. All our support staff are trained in the drug development process, so they can help investigators when they call.

Security also is a high priority for IntraLinks and is incorporated into the hub's new capabilities.

In terms of security, the infrastructure for the hub was designed for business critical information exchange in conjunction with the banking and pharma industries, Jenkins said. It is designed so that you can'st use the system unless you are connected through encrypted sessions. We also use a very sophisticated permission system that's based on roles, access is granted with a user ID and password, but you are only allowed to see what you have permission to see.

The training and testing capabilities are the latest features introduced by IntraLinks and are designed to reduce the number of days to complete study start-up for all phases of clinical trials. In addition, according to Jenkins, there are more improvements to come.

We are going to be introducing an e-signature capability so that users can e-sign documents and that signature will be 21CRF Part 11 compliant, he concluded. We are also offering what we call the e-IRB Hub and a virtual study binder for investigators. The e-sign capability will be available at the end of the second quarter next year, and the virtual study binder and electronic IRB are available already.

For more information on IntraLinks, visit the company's Web site at intralinks.com.