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Everywhere you turn, there are conversations about “paperless clinical trials” and “moving to the cloud” with promises of saving time, reducing costs and decreasing risk in clinical research. It’s unsurprising when you consider the number of people, processes, and information involved in just one clinical study and the total number of studies being run at any given time. Take safety reporting, for instance. A large pharmaceutical company typically distributes about a million safety packages every year to thousands of sites, institutional review boards (IRBs), and contract research organizations (CROs). These packages are often distributed via overnight mail due to the urgent nature of the information. Based on an average expense of $10 per package and this one trial aspect has cost the company $10 million a year.
The cost, however, isn’t the greatest concern. Pharmaceutical companies need to ensure that investigators receive the safety information for them to take appropriate action with their patients. They also need a record of the distribution and delivery of the safety letters for regulatory compliance purposes. These same challenges exist in other study areas like site recruitment and activation.
In a cloud-based environment, clinical trial document exchange and the associated communication and activity with sites and other outside parties becomes instantaneous. You alleviate error-prone manual steps, as well as delays due to different time zones and language barriers. The cloud becomes a place where people, processes, and information come together for real-time, continuous work around the globe. In addition to the obvious time and money savings enjoyed by moving processes to the cloud, there is also an added layer of security and control that is simply not possible in a manual, paper-based environment.
So, how do clinical operations teams make the shift from reams of paper and archaic proprietary systems to a cloud-based environment? It helps to think about the end goal and work backwards. Ultimately, clinical operations teams want to accelerate their clinical trials. In order to take action, teams need access to data that will allow them to analyze situations and make decisions. This, in turn, is reliant on visibility into real-time process status. And finally, in order to have visibility, the process needs to be centralized and standardized to enable a comprehensive view. Simply stated, the roadmap to success is:
Centralize > Standardize > Automate > Monitor >Act
With IntraLinks’ secure online platform for clinical operations, this can be done simply and easily. The company helps clients identify and centralize all documents and participants related to a process, and then develop a standardized framework to organize and identify everything. This allows them to establish workflow and business processes to automatically trigger important activity. Finally, all activity is tracked and recorded, providing real-time status insight to clinical operations teams.
With this framework in mind, moving to the cloud should be a straightforward transition.
About the Author
Alison Shurell is vice president of life sciences product marketing at IntraLinks. She is responsible for building on IntraLinks’ position as the leading software-as-a-service solution for critical information exchange in the life sciences industry. She holds an undergraduate degree from Miami University and an MBA from Baldwin-Wallace College.
