There’s no part of the pharma industry where change happens more rapidly than on the digital side of business. Yet, even with the ever-widening range of software technologies that manage every part of the business, from backend administrative duties to manufacturing automation, some companies are falling behind.
It can be daunting to keep up with all of the latest products — but the effort also pays off when it comes to enhancing operations, having quicker
access to vital information or a treasure trove of useful data.
Despite the upfront price tag for many business management solutions, the investment can save money for over time.
“As pharmaceutical manufacturers consider growth plans for 2018, including new product introductions, personalized medicines, and globalization of markets, greater focus must be placed on minimizing operations costs,” says David Mills, senior principal business development manager at Schneider Electric. “Competition has never been tougher, and with the constant threat of new global competition, now is not the time to lose sight on digital and other continuous process improvement initiatives to drive excess costs out of the business.”
Here’s a look at what’s new and how the latest products can help improve business.
Boosting Workforce Efficiency
Employees are any company’s greatest asset — but even the best employees can improve their efficiency throughout the manufacturing process. Increasingly, companies have been applying user experience management (UEM) tools to improve how employees work.
“Companies are turning to user analytics to ensure that their employees are correctly and efficiently utilizing their enterprise software,” says Brian Berns, CEO of Knoa Software. “The UEM data pinpoints exactly where and why employees are encountering process bottlenecks, errors and inefficiencies, empowering management to address them through customized training, UX re-design, business process changes, etc. This ultimately results in increased employee productivity, expedited business processes and reduced costs.”
According to Berns, UEM tools can also help manufacturers maintain operational visibility, track key performance data, and meet the industry’s strict government and regulatory requirements.
“User analytics can track exactly who interacts with key applications, regulated processes, workflow and more. It ensures traceability by creating a permanent record of all user interactions with the enterprise apps,” he says.
Berns notes that UEM can also be an important tool as more manufacturers scale their operations for growth and migrate to new software platforms like SAP S/4HANA, cloud and mobile.
Waging a war on Paper
Believe it or not, some pharma companies are still tracking information by hand — a habit that can come back to bite them when dealing with the FDA.
“According to the latest information compiled by the FDA, the number one reason pharmaceutical manufacturers receive Form 483s relates to 21 CFR 211.22 (d), ‘Procedures not in writing or not fully followed,’” explains Patricia Santos-Serrao, RAC, director, clinical and regulatory solutions, pharmaceutical, blood and biologics for MasterControl.
In fact, Santos-Serrao notes that half of pharmaceutical companies report in industry surveys that they still manage all or part of their standard operating procedures (SOPs) by hand. In addition to hampering compliance efforts, tracking this information manually increases the chances of making errors.
Instead, switching to Electronic Quality Management Systems (eQMS) for electronic document control and electronic quality management to automate the creation, routing and delivery of SOPs, policies, work instructions, and other critical documentation, can make it easier to retrieve information and track changes.
“When all these processes function in tandem, pharmaceutical companies can markedly improve their chances of avoiding Form 483 Observations,” Santos-Serrao says.
Building a Better Clinical Study
It can take weeks or even months to put together the right protocol for a clinical trial. But a new research software platform from TriNetX has shrunk that process down to minutes.
An idea incubated by Novartis, the four-year-old, venture-backed company has partnered with numerous hospitals, representing 100 million patients. With this data pool at the fingertips of pharma companies, users can analyze patient populations and perform “what-if” analyses in real time. Users are presented with aggregate views, but each data point in the TriNetX network can be traced to healthcare organizations who have the ability to identify individual patients, allowing clinical researchers to develop virtual patient cohorts that can then be re-identified for potential recruitment into a clinical trial.
The platform allows researchers to see the impact of changing certain aspects of the cohort, such as age, in real time to more quickly build the right protocol and test feasibility. This helps companies avoid amendments to their trial, which can delay the process by months or even kill the study for good.
According to TriNetX’s CEO, Gadi Lachman, the platform is not just helping pharma companies, it also serves a greater purpose.
“Our mission is to improve human health,” he says. “By reducing amendments and improving site selection, we are helping to bring new life-saving treatments to market faster. And that feels good.”