Running a clinical trial in the U.S. is expensive. In fact, costs can range anywhere from $20 million to $100 million. Document management is one of the most time consuming and costly pieces of the puzzle. The amount of documents, work items, notifications, and other elements of collaboration is growing, resulting in increased management costs and the need to disseminate important information across the organization quickly and efficiently.
Seamless and efficient document management and exchange can significantly impact the cost and time it takes to complete a clinical trial. Effective integration can be accomplished through a seamless clinical collaboration platform that keeps constituencies connected, informed, and on task by providing access to every document at any time, from anywhere.
There are seven key features companies should look for in a clinical collaboration platform to help achieve seamless collaboration:
1. Collaborative clinical trial workspaces. At any given time, a pharmaceutical company can be actively engaged in hundreds of clinical trials. Imagine the effort and overhead involved with provisioning collaboration websites to support that volume of work using traditional web development methods. Automating the process of creating collaborative workspaces ensures that the websites adhere to established corporate branding standards. This also allows for the creation of a repeatable and non-varied process in which corporate and regulatory standards to be met on a consistent basis.
2. External clinical collaborator self-registration. To support global collaboration, corporate IT departments are being asked to open the network firewall and maintain communication with others outside of the organization. However, many organizations are unwilling to do so because of the potential for security and accountability issues.
Automating the user account provisioning process improves the efficiency of opening the environment to extranet users. In fact, through automation, the administrative burden of workspace creation and any requirements associated with external user account creation are eliminated. As a result, another barrier to effective clinical trial collaboration is removed.
3. Electronic trial master files (eTMF). An eTMF collects essential trial documents in a central location and makes them available to the community over the Internet. As the industry moves toward larger and more complex global trials, an eTMF becomes even more important in streamlining processes, increasing transparency, simplifying tracking, and enhancing security.
To maximize use of an eTMF, companies need to leverage it as a management tool and use it to track progress against documentation-centric milestones within the organization.
4. Enterprise document management systems (EDMS). Many drug sponsors rely solely on shared drives and email for sharing and storing trial documentation. While these can be effective, they cannot scale to meet the needs of larger or more complex clinical trials. Plus, they don’t support collaboration outside the organization.
By addressing every stage of the document lifecycle, an EDMS provides significant advantages in managing the eTMF. For example, assimilating an EDMS into clinical trial operations simplifies the management of essential trial documentation by integrating document management processes into the way employees work on a daily basis.
5. Electronic workflows. Many work items are dependent on the completion of preceding work items. The inability to complete tasks on time can hinder future productivity and decrease efficiency. Creating a standard work item inventory defines what work needs to be done, when it needs to be done, and who is responsible for completing it. It also facilitates the tracking and reporting of what is expected for completion and what is missing from the project. Implementing workflows helps standardize the business process at all points in the trial.
6. Alerts and notifications. Timely communication around key trial events can have a big impact on efficiency and, in turn, regulatory compliance. The ability to quickly communicate critical information virtually to collaborators helps reduce operational costs by eliminating postal delivery, overnight couriers, and fax machines. Alerts and notifications can be used to keep those involved in the process up to date throughout the course of the trial.
7. Investigator portals. Internet portals have been used in the life sciences industry for some time, but the widespread adoption of investigator portals for clinical trials has been slow.
There are a number of elements to consider when designing an investigator portal. For example, a simple, streamlined user interface that requires a few mouse clicks to navigate is much easier to master than one that is overly complex. In an ideal portal, the investigator should be presented with a dashboard overview of important communications such as current work items and key trial metrics when logging in. Less frequently accessed information can be presented on other pages or through tabs.
Even today, clinical trials continue to be paper-based and supported by manual document management processes. Identifying an all-encompassing clinical trial collaboration platform can dramatically reduce the time and effort involved in creating and managing essential documentation.
Seamless and efficient document management and exchange can significantly impact the cost and time it takes to complete a clinical trial. Effective integration can be accomplished through a seamless clinical collaboration platform that keeps constituencies connected, informed, and on task by providing access to every document at any time, from anywhere.
There are seven key features companies should look for in a clinical collaboration platform to help achieve seamless collaboration:
1. Collaborative clinical trial workspaces. At any given time, a pharmaceutical company can be actively engaged in hundreds of clinical trials. Imagine the effort and overhead involved with provisioning collaboration websites to support that volume of work using traditional web development methods. Automating the process of creating collaborative workspaces ensures that the websites adhere to established corporate branding standards. This also allows for the creation of a repeatable and non-varied process in which corporate and regulatory standards to be met on a consistent basis.
2. External clinical collaborator self-registration. To support global collaboration, corporate IT departments are being asked to open the network firewall and maintain communication with others outside of the organization. However, many organizations are unwilling to do so because of the potential for security and accountability issues.
Automating the user account provisioning process improves the efficiency of opening the environment to extranet users. In fact, through automation, the administrative burden of workspace creation and any requirements associated with external user account creation are eliminated. As a result, another barrier to effective clinical trial collaboration is removed.
3. Electronic trial master files (eTMF). An eTMF collects essential trial documents in a central location and makes them available to the community over the Internet. As the industry moves toward larger and more complex global trials, an eTMF becomes even more important in streamlining processes, increasing transparency, simplifying tracking, and enhancing security.
To maximize use of an eTMF, companies need to leverage it as a management tool and use it to track progress against documentation-centric milestones within the organization.
4. Enterprise document management systems (EDMS). Many drug sponsors rely solely on shared drives and email for sharing and storing trial documentation. While these can be effective, they cannot scale to meet the needs of larger or more complex clinical trials. Plus, they don’t support collaboration outside the organization.
By addressing every stage of the document lifecycle, an EDMS provides significant advantages in managing the eTMF. For example, assimilating an EDMS into clinical trial operations simplifies the management of essential trial documentation by integrating document management processes into the way employees work on a daily basis.
5. Electronic workflows. Many work items are dependent on the completion of preceding work items. The inability to complete tasks on time can hinder future productivity and decrease efficiency. Creating a standard work item inventory defines what work needs to be done, when it needs to be done, and who is responsible for completing it. It also facilitates the tracking and reporting of what is expected for completion and what is missing from the project. Implementing workflows helps standardize the business process at all points in the trial.
6. Alerts and notifications. Timely communication around key trial events can have a big impact on efficiency and, in turn, regulatory compliance. The ability to quickly communicate critical information virtually to collaborators helps reduce operational costs by eliminating postal delivery, overnight couriers, and fax machines. Alerts and notifications can be used to keep those involved in the process up to date throughout the course of the trial.
7. Investigator portals. Internet portals have been used in the life sciences industry for some time, but the widespread adoption of investigator portals for clinical trials has been slow.
There are a number of elements to consider when designing an investigator portal. For example, a simple, streamlined user interface that requires a few mouse clicks to navigate is much easier to master than one that is overly complex. In an ideal portal, the investigator should be presented with a dashboard overview of important communications such as current work items and key trial metrics when logging in. Less frequently accessed information can be presented on other pages or through tabs.
Even today, clinical trials continue to be paper-based and supported by manual document management processes. Identifying an all-encompassing clinical trial collaboration platform can dramatically reduce the time and effort involved in creating and managing essential documentation.
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