Glemser
Streamlining Authoring and Global Labelling

Drug research is ever-evolving. As diseases like cancer and diabetes become more prevalent, the pharmaceutical industry strives to develop new products and drug combinations to treat and cure them. The pharma companies are required to adhere to standards like IDMP, HL7, DADI, and a variety of regulations across the world. They are required to provide appropriate electronic documentation when presenting their research findings on a drug’s safety profile, in outputs that vary by region and health authorities. The process starts for many with core data sheets in the U.S. and an SmPC in Europe. This necessitates the collection and compilation of a product’s clinical data from various sources, which is a time and labor-intensive process, subject to long lead times and manual errors.

Glemser, a technology enabled service provider for the life science industry with over three decades of experience in global labeling and compliance, is streamlining the label generation process for pharmaceutical companies through its SaaS-based ComplianceAuthor™ Solutions. The end-to-end system simplifies the global labeling process with a reduction in label generation time of 50 percent, which is critical in product approval, patient safety, and quality. Glemser’s modernized system overlays and interfaces client’s existing data repositories and RIM systems, allowing clients to utilize multiple data sources. This approach allows for the aggregation of data in a way that is minimally invasive and reduces organizational change management.

“Through our ComplianceAuthor™ Solutions, we save huge amounts of time and cost while providing sustained quality improvements and compliance for clients that want to make a difference in the research and development of vaccines and new drugs,” says Kevin Morgan, CEO of Glemser.
It accomplishes this through a three-pronged technology-enabled service involving natural language technologies and continuous publishing with an easily adaptable configuration. Glemser uses natural language processing to collect comprehensive data from numerous databases, recognizing changes to data at the source document and passing those changes downstream for sustained compliance and change management. ComplianceAuthor™ Solutions leverages this automation but also keeps a human in the loop to approve the suggested next best actions. The company also aids in translation management and output management, as all data is configured under a single controlled source of truth.

Glemser additionally developed an out-of-the-box configuration that is easy to implement. The technology, stores meta-data at the most granular level of specificity in an agency-neutral format, called controlled compliant components. This engineering design approach, known as agency-neutral, allows ComplianceAuthor™ Solutions to generate any output or document type. The authoring system’s workflow is highly regulated and every phase is audited. This allows organizations to harmonize data in any of clients existing systems and work with it seamlessly, reducing the time to generate a submission ready label by up to 50 percent.

Using a ‘zero-defect’ strategy, Glemser emphasizes the delivery of these services and technology on time, on budget, and on benefit. It begins working with a client by assessing their outcomes through the ‘Glemser way’ and understanding what the required templates and inputs are for a given product. It uses an agency neutral approach and format that is easy to scale to meet current and evolving regulatory requirements. Glemser’s understanding of document types, data types, and system interfaces has been proven over thirty years. Leveraging a MS Word interface, the system is easy to adopt with minimal required training, creating a compressive and familiar user experience.

Powered by its global delivery team of technical and functional experts, Glemser also provides post-production support to ensure that its client’s systems and applications work correctly. Glemser supports clients that have implemented test specifications, analytical methods, product specifications as well as clinical and global labeling. Through its robust team’s support, Glemser establishes long-term relationships that last over a decade with clients.

The strong foundations Glemser builds with its clients are especially highlighted in its work with a prominent German manufacturer of medications to treat COPD, cancer, and animal health. The company has been using ComplianceAuthor™ Solutions for over 12 years in the controls, manufacturing, and compliance area of four of its global manufacturing plants to assist in generating data on raw materials and finished goods testing. It resolved process management concerns and ensured consistent data flow on the cloud, supporting a user base of over 1,000.

Glemser is similarly easing the authoring process for many other pharma industries, helping them make a difference in the human health space, and is the go-to solution provider for global labeling.