Time to market has a significant impact on profits, particularly in the ultra-competitive life science and pharmaceutical industries. Delays in bringing products to market can lead to deferred or missed revenues. But, the heavily regulated drug approval process requires a variety of inputs and approvals to validate each step of the process, extending the development period. While there are many hurdles to clear, skipping any of these steps can expose operations up to compliance risks.
Pharmaceutical firms with well-tuned automation strategies that enable professionals to easily collaborate around the drug approval process will be better positioned to capitalize on market opportunities. Improving how teams are built and creating workflows that move documents and data quickly through the process are two areas that can be streamlined with smart automation.
Each stage of the drug approval process, from research to publications to marketing copy, requires input from a variety of professionals. Statisticians, physicians, chemists, pharmacologists, and copywriters all must contribute, approve and validate content and data as it moves through the pipeline. In many cases, these experts are third parties that must be properly vetted to ensure that they are in good standing in their field. Working with experts that have been excluded or disbarred can jeopardize the process. This task of researching and documenting contractors’ status can be very manual and slow.
Automating this collection of data and documentation of certifications can lead to significant time savings. Executing consulting agreements with contractors is another important part of the process which, if skipped, can lead to legal issues down the road. An automation platform that enforces rules to properly vet and engage third parties is a smart way to reduce risk.
Automating approval workflows
Once resources are procured and vetted, managing and coordinating how collaborators work together is key to streamlining the approval process. Whether it is an approval of a research publication or a study protocol review, approvals need to be routed to the appropriate people at the right stage of the process. Appropriate controls and constraints also need to be in place and enforced. For example, a minimum number of people may need to review and approve a document. Automated workflows can be built to ensure that documents don’t move forward without the required number of experts signing off on content. Rules within the workflow can also force users to record key data points that may be critical in the event of an audit.
With so many different professionals required to complete so many tasks, workflows can get complicated, especially at large firms running a high volume of projects. These approval workflows can be unique to every company, clinical study, research publication, or marketing copy. Over the years, organizations have learned what works and what doesn’t within their operation based on corporate culture, markets, products, resources, and risk tolerance. In some cases, this institutional knowledge lives in the heads of more experienced professionals and is applied manually to define the path that each project takes through the approval process.
Instead of reinventing the wheel or mapping workflows for each individual project, significant efficiencies can be gained by standardizing and automating the process. By implementing a platform where rules and steps can be standardized, workflows can automatically be created based on the types of products in the pipeline or available resources. This not only significantly increases efficiency but also documents institutional knowledge.
Workflow platforms can also provide greater visibility of the entire process to identify bottlenecks and enable changes to the workflow before the process stalls. Incorporating rules and analytics into your workflow automation also allows the system to identify critical paths so professionals can work in parallel, leading to greater velocity. By automating the administration of the approval process, products can get to market faster and at a lower cost.
Low-Code vs. Build vs. Buy
By implementing a low-code solution, pharmaceutical companies can create systems that adapt to their unique processes instead of adjusting processes to an off-the-shelf generic software package. Low-code BPA options are also much less disruptive, quicker, and less expensive than building a solution from scratch.
The rush to digital transformation and automation is redefining how businesses operate. The velocity of change will only accelerate. Streamlining administrative tasks that hinder the drug delivery process will lead to better corporate performance.