As regulatory teams write and prepare documents for submission to government agencies and regulatory bodies, it’s important for them to be equipped with the right tools to help them work as efficiently as possible. Tools that support the process of locating supporting safety literature, organizing and centralizing content, checking and clearing copyright permissions, and easily accessing saved references are invaluable.
CCC’s RightFind Suite provides these tools to regulatory teams, facilitating quick and easy access to scientific literature and making it easy to get appropriate copyright permissions for submissions to government agencies. The platform also includes built-in options for centralizing and organizing content, as well as citing while authoring regulatory documents.
Access to Supporting Literature
When regulatory teams need scientific literature to support safety and efficacy claims, they can search RightFind Suite’s database of over 168 million citations to find the exact references they need. Getting content is fast, too, with most of the content being available instantly and over 98% of documents delivered in under 24 hours.
For those cases when a document that is needed to back up claims isn’t available right away, CCC’s built-in Advanced Referencing Service (ARS) will go to the “ends of the earth” to track down and provide hard-to-find literature. All this content, whether it be instantly available or harder to find, can be easily requested together with the appropriate usage permissions for submissions, meaning teams don’t need to spend extra time checking that they are getting their literature compliantly.
Furthermore, for submissions with clean-copy requirements for documents submitted, such as to the FDA, teams have the option to request a clean version upfront. This option sends the document requested to CCC’s team for review and clean up, meaning you receive a clean copy that can be submitted without further edits, staying in line with submission guidelines.
With rights information and checks built-in, using RightFind Suite also means users can just request the literature they need, knowing the tool itself will check the rights you have to share copyrighted content and will only route orders to purchase when the content and permissions needed aren’t already available. Additionally, deliveries of up to 50 documents can be “bundled” into a single file, providing an easy, single download of the items needed.
Organizing and Centralizing Documents
The lack of a centralized library of documents and references can be particularly frustrating when the time comes to track down an important piece of supporting literature. Without dedicated libraries, teams end up storing content locally on their own desktop or relying on shared folders that often don’t have the appropriate access controls. RightFind Suite gives users the option to use a Personal Library to save articles and documents they’ve requested or accessed, as well as the ability to create Shared Libraries that house and share documents with others. With Shared Libraries, teams have dedicated workspaces to save references and full-text articles for quick retrieval when needed, along with the ability to grant and control access for only the appropriate colleagues.
As an example of the usefulness of Shared Libraries, take the common scenario of preparing for regulatory submission. Often, a dedicated Shared Library is created just for that product and is made accessible to the various teams involved in that product’s lifecycle. Those teams can then safely store materials that will be needed for further research or to back up claims in the future. Within a library, teams can also use tags to add keywords to references and documents, making finding and retrieving items later much easier.
Whether a user is in their own Personal Library, or in a collaborative Shared Library, RightFind Suite’s rights-aware libraries seamlessly check permissions for sharing automatically as well as giving users options to request additional reuse permissions for themselves, all at the click of a button.
In addition, RightFind Suite’s integrated Digital Library means purchased content is checked and stored centrally for reuse across the company when appropriate reuse permissions are available. For subsequent requests, covered users will get literature from the Digital Library automatically if their intended use is covered by permissions granted by their company’s copyright license, eliminating the need for manual checks of what’s already available and avoiding duplicate purchases.
Easy Citation Management and Formatting
Building on the integrated search, ordering, organization, and libraries capabilities of RightFind Suite, the RightFind Cite It add-in for Microsoft Word and Microsoft PowerPoint allows users to quickly and easily pull citations into the documents they are creating. Users can search the full RightFind Suite catalog of over 168 million citations, or they can search their own Personal and Shared Libraries where they have already brought together relevant references, including the ability to search by the tags associated with the documents within their libraries.
RightFind Cite It even allows users to instantly pull up the full text of the items they are citing from within Word and PowerPoint, opening the exact copy from the exact library that was just cited. This powerful shortcut allows users to review texts and easily verify information, as well as providing options to check available permissions and even clear additional permissions, if needed. Users can also choose from over 10,000 available citations styles, so sticking to regulatory filing format guidelines is one less thing to worry about.
To demonstrate the power of RightFind Cite It, take another common scenario where it can greatly benefit users; a medical writer preparing a submission will often create a library, and then save all supporting literature they will need for the product in this library, assigning tags to categorize the various items brought together. When authoring the submission, that writer can search for and cite items from that library, using the tags they added to get to the right references quickly.
The Right Tools for the Job
From search, to content acquisition, to organization of supporting literature, to citation management during the authoring process, CCC offers the right tools to help regulatory teams get the job done efficiently and compliantly.
Teams can access up-to-date, relevant scientific literature with ease using RightFind Suite, and can also store content and references in centralized, organized libraries. Intuitive, built-in permissions checks that integrate CCC’s copyright licenses allow teams to easily see what permissions they have available to use a document and to request appropriate additional permissions seamlessly. The integration of RightFind Cite It with RightFind Suite takes the solution’s usefulness to another level, allowing writers to quickly find, cite, and access references and literature within regulatory documentation. Powerful, easy-to-use tools for literature access and management mean regulatory teams have less to worry about and can complete their work more efficiently.
Keep Learning: