The life sciences industry is faced with a conundrum. Now serving a global marketplace, it must meet all local regulations while also continuing to improve efficiencies and speed to market. As a result, the industry has engaged affiliates and remote, external distributors throughout the world to expand its footprint while maintaining needed flexibility to weather economic trends. The resulting network of small, regional affiliates/distributors/partner companies may not be networked with the central sponsor when handling submissions. As such, affiliates typically manage information in their own local systems and must duplicate their regulatory data along with a subset of their documents to be housed within the headquarters’ system. This approach is not only inefficient but also increases the margin for error and noncompliance and limits sponsor visibility into critical documents and processes.
A recent study on Regulatory Information Management (RIM) practices conducted by Gens & Associates identified the need for “integrated and aggregated information regardless of function and geography” as a growing focus of the industry. Yet, many companies are still dealing with local systems, paper processes and tracking spreadsheets. Although there is often certain comfort in allowing affiliates to use their own systems that are tailored to local requirements, such practices lead to significant waste. A full 25% of local affiliate time is spent handling nonvalue activities such as duplicating data entry, finding information, and responding to requests from the central authority due to concerns on data quality. These activities represent a substantial expense, which could be greatly reduced with one global, authoritative system. With today’s advanced cloud technologies, affiliates can easily and securely access the corporate system from anywhere, improving efficiency, accuracy, and compliance worldwide.
As an example, a global biotech company struggled to see what its regional affiliates and distributors had done with periodic safety update reports (PSURs) distributed via CDs. PSUR status updates were collected via email and phone calls, and then manually recorded in spreadsheets. Now, the company leverages a globally accessible cloud solution to distribute and track its safety update reports, increasing visibility and the reliability of meeting regulatory requirements.
A growing number of sponsors, in fact, are moving to cloud solutions to globally harmonize submissions processes. Small, local affiliates with little-to-no IT support and rudimentary tools can connect to the corporate cloud system anywhere there is an Internet connection, and retire old systems completely. Consolidating systems cuts administrative overhead and eliminates redundancy. For example, when affiliates update a specification, manufacturer, or label using a global cloud system, they no longer have to also update their local tools as well. Duplicate sets of information are eliminated and replaced by a single, trusted, authoritative source of information which fosters improved compliance.
Organizations with a central cloud system save resources by:
- Capturing the activities of both headquarters and their affiliates in real time
- Eliminating duplicate data entry
- Providing ongoing transparency into affiliate activities to improve compliance
- Aggregating information for better decision-making and audit readiness
One key caveat: to properly engage and collaborate with affiliates throughout the globe, a centralized cloud application must offer an easy user interface that’s highly intuitive. “Often, when affiliates get full access to the native application…they become overwhelmed with the complexity of the system,” explained Steve Gens, industry veteran and founder of consultancy Gens & Associates. “What works for the daily user doesn’t work for casual users like those at the affiliates.” To avoid overwhelming the occasional user with complicated functionality, the central system should incorporate a familiar, user-friendly interface while also provide the specific functionality needed to meet local requirements. The global system must track the documents, data, timelines and reports that are relevant in-region. This is the only surefire way to ensure affiliates will retire local systems so the organization can consolidate technology and improve overall efficiency.
About the Author
John Lawrie has nearly 20 years of experience in the pharmaceutical industry. He is currently director of product strategy for the Veeva Vault Submissions application. In this role, he is responsible for product direction in supporting regulatory submissions content management as well as Vault Submission’s position within the overall Regulatory Information Management (RIM) landscape.