Pharma & Life Sciences

Life Sciences organizations around the world face a broad range of information challenges in product knowledge capture, regulatory affairs and drug manufacturing. As each new product or drug moves through the development pipeline it generates a significant amount of heterogeneous, complex data – most of it locked away in silos that are difficult to access let alone combine for timely analysis or reporting.

At Smartlogic we work with global Life Science organizations to unify and leverage the valuable insight and information locked within their unstructured information to support product knowledge capture, comply with regulation and streamline the development pipeline.

“With Semaphore, we’re linking our content to real business outcomes”

– Adam Duckworth, MERCK

Support Product Knowledge Capture

The process of moving a drug from research and development, through prototype manufacturing to industrial scale manufacture is a long and information intensive process. The volume and diversity of information generated throughout the manufacturing process is located in multiple internal and external silos, in a variety of formats and of diverse vocabularies. To be effective, Life Science manufacturers must minimize the time and effort associated with information management and focus efforts on decreasing costs, reducing defects and managing production delays.

Semaphore helps Life Science organizations harmonize, optimize and connect the valuable information generated throughout the manufacturing life-cycle and make it available to the enterprise for key decision making processes. Our ontology management, sophisticated auto classification and search tools provide a framework that helps organizations:

  • Improve knowledge transfer, bridge knowledge gaps and improve knowledge worker productivity in the research and development process.
  • Decrease costs associated with production delays, supply chain failures and product defects.
  • Consolidate clinical trial processes, results and deviations to facilitate reporting.

With the Semaphore platform, Life Sciences organizations can quickly find the most relevant information associated with a process, clinical trial or production development and save time, reduce expenses and eliminate lost opportunities associated with a lack of quality information.

Comply with Regulation

Regulatory affairs departments face a number of challenges from ensuring their organization is in compliance with regulation and legislation associated with their domain, to working with federal, state and local agencies on specific issues that affect their business (i.e. working with European Medicines Agency) to advising their company on the regulatory aspects and climate that would affect proposed activities (i.e. promotion of a new drug).

The drivers for these activities come from a complex legal system focused on Pharmacovigilance and adverse event reporting, health authority information requests, Identification of Medicinal Products (IDMP) as well as other reporting requirements. In order to be effective, they need access to all relevant information in a timely manner to avoid sanctions and damage to their reputation.

Up to 70% of the information required to comply with regulatory submissions in an enterprise is locked away in unstructured content. In most organizations the information is dispersed throughout the enterprise in separate silos, of varied formats and contains multiple nomenclatures. Semaphore extracts the data required for regulatory submissions, consistently, accurately, and cost effectively so you can:

  • Harmonize compliance information across data sources
  • Quickly and efficiently respond to health authority requests
  • Reduce rework and reporting effort
  • Identify deviations from protocol and reduce errors
  • Form a reliable and comprehensive picture of the information available regarding adverse events and clinical risks

Semaphore eliminates the hassles and reduces the risks associated with regulatory reporting. Our model-driven classification and superior visualization, search and discovery tools streamline reporting processes so you can stay focused on turning profit and increasing ROI.

Streamline the Drug Manufacturing Pipeline

New drug development is a critical function in Life Sciences companies, and it is an increasingly costly one. Life Sciences organizations want to reduce the time it takes to develop new drugs and identify candidates that will fail early. As a drug moves from development through regulatory submission to commercialization and production, the volume of information generated at each stage in the process immense.

Much of the accumulated knowledge is inaccessible; stored throughout the enterprise and in external public and proprietary content repositories. To be effective they require state-of-the-art semantic technologies that can leverage Linked Data vocabularies (i.e. SNOMED, RxNORM, etc.), unify information across diverse information repositories and maximize information to accelerate innovation cycles to identify:

  • Known targets and leads for a given indication
  • Biomarkers that provide an early indication of drug effectiveness or disease identification
  • Side effects of a specific compound that suggest repurposing for alternative therapeutic uses
  • Areas of intervention and knowledge about causal factors, while monitoring the results of clinical events

Semaphore Ontology Editor lets you create a model that represents the relevant concepts associated with your business and the relationships between them. Our powerful Classification Server enriches every document with precise and consistent metadata to identify the relevant concepts (i.e. chemical compounds, observations and results) from your model. Semantic Enhancement Server and Search Application Framework consume the metadata allowing researchers to quickly visualize and locate the information necessary to identify unsuccessful drugs early in the development pipeline; saving time, money and freeing up valuable resources for other, potentially successful projects.

Our Approach to Solving your Challenges

These are just a few examples of how we work with clients to maximize the value hidden in their unstructured content. Life sciences organizations use the Semaphore platform to manage these as well as other use cases to reduce costs, streamline processes, comply with governmental regulations and mitigate risk:

  • Real world evidence
  • Competitive intelligence
  • Clinical trial management

Smartlogic offers a unique set of tools and technologies that enhance your content management investment and provide cost savings through the reuse and repurposing of components. Whether your content management system resides on-premise, in the cloud or a hybrid mode, Smartlogic approaches your challenge with a proven and well tested process for enterprise information management in the Life Sciences sector.