Life sciences customer relationship management (CRM) is a set of technologies and systems purpose-built for pharmaceutical, biotechnology, medical device and diagnostics organizations to enable compliant engagement across the entire customer life cycle. The main function of CRM is to enable and support key business activities, including nurturing relationships, delivering educational and promotional content and influencing demand with healthcare providers (HCPs), key opinion leaders (KOLs), payers and other medical stakeholders. CRM supports industry-specific use cases, including salesforce automation, omnichannel marketing campaign orchestration, medical information and scientific exchange, KOL relationship development, market access and strategic value planning, promotional tactics execution and regulatory compliance tracking.
Digital asset management (DAM) is a self-serve content repository. It facilitates the management, ingestion, storage, organization and distribution of all types of content an organization uses. The content includes any digital asset, such as text, graphics, images, videos, audio, design files and product information used by an organization to communicate with internal and external audiences. DAM platforms not only support marketing but can also serve internal and external parts of the organization including sales, HR, legal, finance, call and service centers, third-party suppliers, agencies, and distributors. The primary purpose of a DAM is to manage governance of digital assets and make them available and useful, enabling brand consistency across the organization. Beyond its role as a self-service solution, DAM products are part of a content operations ecosystem, which includes capabilities that overlap across technologies such as content marketing platforms (CMP), marketing work management (MWM) and product information management (PIM). Individually, technologies support different variations of content taxonomy, content editing, management of and content access controls to third parties (e.g., agencies). Their goals are to drive efficiency, transparency and scale of content deliverables across the organization. The primary purpose of a DAM is to manage governance of digital assets and make them available and useful, enabling brand consistency across the organization. DAM platforms serve as a repository for all digital content assets. Organizations that have a large number of digital assets use a DAM solution to manage, catalog and transfer files, and to store digital assets. The solution allows organizations to share and edit digital assets across multiple platforms and channels. DAM platforms can support external partners with portals to access an organization’s assets. Overall, it is a self-service content repository and can facilitate collaboration.
Digital validation tools deliver life sciences manufacturers tools, services, expertise and applications to assure that documents, software, operations infrastructure and processes remain optimized and comply with the requirements set out for specified purposes of their intended use. Tools and services may support specific regulations or requirements, such as the U.S. FDA’s Title 21 Code of Federal Regulations (21 CFR) Part 11 and observed industry best practices (e.g., GxP, cGMP or GAMP). They help in identification, assessment and mitigation of risks associated with the validation process while also facilitating the creation, approval and storage of validation documents. These tools can easily scale with the growth of the organization, accommodating increased validation demands without a corresponding increase in manual effort.
Legal refers to products and services that support legal practice, regulatory compliance, and legal operations across law firms, corporate legal teams, and government agencies. This category includes markets that focus on enabling organizations to manage contracts, litigation, intellectual property, legal documents, ensure compliance, and enhance operational efficiency.
Gartner defines an e-clinical system as the software solutions or platforms used to conduct clinical trials, together supporting the study setup, conduct and analysis of the clinical research process. The clinical trial process begins with a protocol, which defines the trial methodology, and ends with trial results and study endpoints that support final study conclusions in a clinical study report. E-clinical systems support this end-to-end process by collecting, cleaning and interpreting clinical trial data as well as supporting other trial processes such as site monitoring, biostatistics and clinical supply.
RIM Solutions Allow Organizations to Scale and Speed Products to Market: RIM solutions are a set of key capabilities that a life science company needs to manage the regulatory approval and maintenance of a life science product for commercial use. Each RIM solution capability addresses a specific aspect of the process to gain and maintain regulatory authorization in one or more regulated markets. RIM solutions can be stand-alone point solutions or part of a RIM platform, and either deployed on-premises or in the cloud. Much investment in these solutions from life science companies has involved the shift to cloud deployments (primarily public cloud deployments) over the last five years. RIM capabilities consist of solutions used for: Product registration management Regulatory intelligence and regulatory requirements management Product detail and product information management Dossier management Submission content management, including authoring, development and approval Product label and promotional material development Health authority interactions, communications and commitment tracking Submission planning, production and archival
Gartner defines the market for quality management system (QMS/eQMS) software as stand-alone digital solutions with embedded emerging technological capabilities that enable organizations to systematically manage, monitor and improve the quality of their products, processes and services. These software solutions help organizations meet customer quality expectations and maintain compliance with international standards as well as industry-specific regulations. QMS software is designed to help organizations reduce waste, lower costs, house quality documents, assess risk, track performance, ensure compliance and improve processes. The QMS/eQMS market serves a broad spectrum of industries, including manufacturing, life sciences, automotive, aerospace and defense, electronics, food and beverage, chemicals, consumer packaged goods, services, and more. These solutions are built to help organizations of all sizes, from single facilities to complex, global operations, establish a consistent approach to managing and enhancing the quality of products, processes and services throughout the value chain.