With global health and regulatory authorities continuing to push for tighter regulations surrounding disclosure, transparency and e-standards, pharmaceutical and other life sciences companies are increasingly challenged by fragmented, quasi electronic, paper-based processes and often out-of-date technology systems. Many organizations simply lack the process and technology to effectively operate and comply in a rapidly changing regulatory environment. The impact is significant, often translating into costly product delays, regulatory fines and lost business opportunities.
Life sciences companies must re-evaluate their existing processes and systems and consider new ways to encourage collaboration, streamline workflow, and keep costs in check to improve content compliance. Although there are content management “like” systems, most are “document-centric” and lack the underlying standards-based business intelligence required by life sciences companies. In this article, I recommend strategies and best practices to help life sciences companies manage and automate these processes to streamline content compliance and reduce development costs while bringing higher quality products to market faster and more efficiently.
The Cost of Content Compliance
The cost of bringing new drugs to market today ranges from $800 million to $1.2 billion and research firm IDC estimates that roughly 26% of that cost goes toward the content requirements associated with regulatory compliance.
As the industry and regulators work together to improve the new drug submission and approval process, there are a number of different global standards and regulatory mandates such as Clinical Trial Disclosure, Electronic Common Technical Document (eCTD) and Structured Product Labeling (SPL), which life sciences companies must comply with throughout the product lifecycle. The impact of non-compliance to these standards is significant and includes costly product delays, regulatory fines, and lost market opportunities. A current example of regulatory fines is occurring in the State of Maine, where there is a $10,000 fine per day for non-compliance with clinical trial posting rules. Other state, national and international regulatory bodies are enacting their own mandates and oversight activities as well.
To satisfy these existing and upcoming compliance mandates, avoid costly delays in approval and/or penalties and the potential negative impacts to their brand image, life sciences companies must take stock of their existing business processes pertaining to content management and reuse. These new processes should be enabled through the usage of state-of-the-art system solutions and technologies providing an integrated, collaborative solution across the product life cycle – from discovery through commercialization.
Best practices and information technology can play a huge role here. The right technologies can promote compliance and operational efficiency by automating the transactional tasks within quality compliance, regulatory affairs and clinical support operations. By automating and streamlining the complex content exchange and submissions requirements throughout the product lifecycle, companies can enforce regulatory compliance and automate the many tasks required for clinical trial disclosure, e-submissions, global labeling, and other standards.
Six Steps to Ensure Content Compliance within the Life Sciences Industry
1. Automate process and workflow.
If your current processes are manual or “document centric,” you are vulnerable to errors and discrepancies. You may also lack the ability to easily track history and gain visibility into whether or not a submission is compliant. A two-phase process can help you achieve an automated workflow:
Phase 1. Look for an easy-to-use content management environment that has regulatory guidelines built in. It should include an XML-based technology backbone to comply with the new technology mandates for communicating with the regulators during submissions, labeling, disclosure activities and other forms of interactions. Make sure that the content compliance system is designed to manage the entire lifecycle of the regulated content – from internal authoring, review, approval and external communication, to compare, reconcile and maintain regulatory documents going forward. It should also be configurable to automatically track milestones and notify stakeholders and content contributors when a form has moved (e.g. parent/child relationship tracking) to the next stage in the workflow and/or requires an action from them.
Phase 2. During this phase, the content compliance system is integrated with your existing information systems automating workflow, minimizing data duplication and entry during the present day highly automated regulatory submissions process.
2. Optimize submissions through collaborative content authoring and review.
Traditionally, regulated submission procedures have not been conducive to multiple authors and reviewers. In most cases, a significant amount of effort and time is ineffectively spent throughout the process as contributors wait to be emailed their section to add content or review. Then, once that process is completed, the content and feedback needs to be compiled, verified and published which leads to significant resource efforts and time delays.
Ideally, your content system features collaborative authoring with role-based access control. This enables authorized authors and reviewers to work on a document simultaneously, greatly reducing cycle time. Reviewers can simultaneously add comments for authors allowing all to view their respective comments by tracking their text edits to show their suggested changes – hence streamlining the overall process. The technology should automatically facilitate version control, tracking all changes, so there’s no risk of overwriting another’s work accidentally. In addition, the system should be based in the XML technology while retaining every detail of revision history in the event of a future change or audit.
3. Reuse and repurpose content to satisfy global requirements.
With the advent of common/similar global regulatory requirements, content management solutions should be viewed in the context of compliance within both the U.S. and international regulatory guidelines. To accomplish this goal, the content management solution requires a level of integrated and configuration capabilities to enable the compliance objective to be met for the client. Submitting information for the same product in multiple countries should not require you to reinvent the wheel each time to ensure compliance with varied submission standards and requirements. Look for a solution that is “standards-ready” and pre-configured to comply with different global standards and regulatory mandates such as Clinical Trial Disclosure, eCTD, SPL/PLR, and other electronic submissions standards so that your users can focus on content, and not compliance.
4. Enable easy adaptation to evolving standards.
As regulations continually evolve, in such areas as electronic submissions, disclosure standards, labeling the regulatory communication process and submissions requirements are likely to change too. Look for a solution that incorporates FDA and other global requirements and is designed to absorb and validate changes as quickly as possible. The technology should allow you to rapidly add new form fields or modify existing ones. In addition, look for a solution that meets 21 CFR Part 11 requirements and provides validation with a built-in audit trail, security and authentication.
5. Evaluate both Software-as-a-Service and perpetual licensing.
Look for solutions with flexible delivery options, and choose the option that best fits your needs: 1) A perpetual software license allows for the outright purchase, installation and in-house operation of the software with an annual maintenance fee for upgrades and support; 2) A Software-as-a-Service (SaaS) model allows the provider to license the application to the customer for use as a service or “on demand” for a monthly fee, eliminating the often large, upfront costs associated with software purchase and implementation.
6. Focus on ease-of-use.
Your content compliance solution must appeal to the people that need to use it – business users, managers, regulatory professionals, clinical staff, etc. As such, your solution should be able to work within your existing organizational framework and include the ability to extend and adapt over time. It should also leverage a familiar intuitive interface that doesn’t require a change in behavior on the part of your users. Many Web 2.0 applications provide familiar, desktop conventions and “Microsoft Office®-like” authoring environments.
Faced with the daunting challenge of upgrading quasi electronic, fragmented, often paper-based-processes make timely postings, filings and ongoing regulatory communications nearly impossible. Life science companies must look to improved business processes and technologies to comply with the changing regulatory environment. The steps recommended above are very practical and achievable strategies to ensure compliance and manage costs in this environment. Each of these strategies can be used individually or in conjunction with others to take greater control of the regulated content lifecycle. The benefits are multi-dimensional. Streamlining the lifecycle content management process reduces the risk of delays and potentials for fines, while continuously increasing your overall compliance and regulatory communications throughout the world.
About the author:
Stephen Bergson is the executive vice president of commercial operations for Virtify, Inc. (http://www.virtify.com), a provider of Enterprise Content Compliance software solutions for life sciences companies. He has been in the management consulting and software services industries for 25 years and worked with many of the world’s leading life sciences companies helping them streamline business processes, accelerate time to market and reduce operational costs in regulated environments. He can be reached at [email protected]