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Infosys E2B R3 XML Validation Utility

Today, the E2B standard for submission of adverse events is an essential component of global pharmacovigilance and drug safety systems. The E2B standard has undergone multiple revisions since its adoption in 2001. The E2B (R3) guidelines encompass advances in the pharmacovigilance sciences made over the last few years and requires capturing rigorous data with increased frequency and granularity. Therefore, this standard will enable life sciences companies to improve the consistency and accuracy of adverse event reporting.

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Metadata -driven standardization using Oracle Life Sciences Data Hub

Having identified Oracle LSH as one of the core applications in the Oracle HSGBU stack, Infosys has developed 3 different solutions which extend LSH’s functionality and address some frequent pain points. Backed by a flexible customization framework and an established implementation methodology, these solutions augment LSH’s functionality and offer a better RoI.

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Transmission of adverse event data from Oracle Clinical to Argus using E2B

In the Life Sciences industry, enterprises in the clinical development space face challenges in the collection, monitoring and analysis of diverse data across clinical development and safety processes. Linkage between clinical data management system and drug safety systems is of great importance from a compliance as well as business perspective. Infosys has defined a structured and planned approach for safety data migration and integration of SAE data between safety and clinical data management systems. It consists of predefined mappings between certain source systems; custom ETL routines for automating data transformation & migration, backed by comprehensive validation resources.

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Risk-based monitoring of clinical trials

The Infosys RBM solution attempts to improve the clinical and commercial success for life sciences organizations. It helps organizations to focus on critical study-parameters and relies on a combination of remote and onsite monitoring.

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AI-Driven Automation in Life Sciences

AI and automation present the Life Sciences industry with the opportunity to transform traditional processes across discovery, development, manufacturing and regulation that will bring medicines faster to patients. Complex drug discovery and computational bio and chemistry modeling powered by AI hold significant potential to deliver early insights into the working of drugs.

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Infosys Solution Suite on S/4HANA 1610 for Life Sciences

Going digital is vital for today’s Life Sciences organizations. Enterprise Resource Planning (ERP) is at the heart of an organization’s system landscape. S/4HANA Enterprise Management delivers a state-of-the-art digital core for this digital transformation. Infosys CaPSule, the solution suite on S/4HANA for life Sciences, enables pharmaceutical manufacturers and medical device players to rapidly design a robust green-field template.

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Data management – A critical constituent for IDMP compliance

In their constant endeavors for safer medications and to improve patient safety, regulatory organizations are gradually moving towards the implementation of the Identification of Medical Products (IDMP). While the IDMP guidelines are maturing, life sciences organizations are making efforts to be ready to achieve compliance.

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Business benefits of Infosys Regulated Document Management platform

Ensuring well-managed documentation that abides to GxP guidelines can be a complex and time-consuming endeavor for life sciences organizations. However, turning a blind eye to regulatory compliances can have serious implications and can potentially lead to license restrictions. Infosys Regulated Document Management platform is a fully-integrated and managed cloud-based offering that provides well-defined and user-friendly document lifecycle management in compliance with GxP guidelines.

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Empowering the life sciences industry with future ready solutions

The life sciences industry is transforming into a collaborative ecosystem for better science, dynamic business strategies, patient centricity, and a data-driven ecosystem. At Infosys we understand this need and have developed a host of solutions and services that life sciences organizations can leverage across their value chain.

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Global Batch Traceability (GBT): Faster deployment, reduced TCO, and enhanced patient safety

Statistics show that product recalls significantly impact revenue in the pharmaceutical industry, thus having a responsive GBT solution in place is important. Infosys has extensive knowledge garnered from implementing SAP GBT for multiple pharma customers, and having developed the Infosys solution suit for GBT.

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Infosys Serialization Track and Trace Solution Suite

Product authentication and traceability is the need of the hour in the fight against product counterfeiting, reimbursement, fraud, diversions, and medical errors. Infosys offers end-to-end tracking of the pharmaceutical supply chain from active and inactive ingredients, finished drugs to national and regional wholesalers, hospital and pharmacies and patients.

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Infosys Life Sciences Regulatory Submission Platform

The tedious process of regulatory submissions often prevent organizations from realizing the benefits of investments in research and new markets. The Infosys regulatory submission platform accelerates and streamlines all aspects of regulatory submission – from planning, document creation, review and approval, tracking and submission.

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Infosys Solution Suite on S/4 Hana for Life Sciences

The Infosys solution suite on S/4HANA for the life sciences enables pharmaceutical manufacturers to rapidly design a robust Greenfield template and also facilitate conversion from ECC to S/4HANA in a Brownfield scenario.

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Identification of Medicinal Products (IDMP) compliance made simple

Identifying, sourcing, qualifying and curating data requirement for IDMP is crucial. At Infosys, we help pharma clients chart their roadmap through this process by offering a robust, futuristic solution to ensure your success.

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Infosys ASM offerings in Research and Development, Safety and Regulatory (RDSR)

Research, Development, Safety and Regulatory (RDSR) is a core function that drives sales for IP-driven life sciences organizations. With a host of solutions, Infosys enables pharma companies and organizations related to medical devices to meet regulatory compliance, portfolio rationalization, application decommissioning, and more. This is achieved by leveraging its experience in application support and maintenance (ASM). Read this brochure to review our comprehensive offering.

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Risk-Based Monitoring (RBM) – a mechanism to enhance clinical trial monitoring process

Infosys RBM solution attempts to improve the clinical and commercial success of life sciences organizations. It will help them focus on critical study parameters and relies on a combination of remote and onsite monitoring.

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Infosys Digital for life sciences

The digital revolution has unleashed previously unimagined possibilities connecting brands with customers and stakeholders. In Life Sciences, connected devices and the data explosion come together to offer companies a whole new world of untapped opportunities. Infosys Digital combines deep expertise in healthcare IT, analytics, and consumer engagement to offer a comprehensive suite of best-in-class solutions.

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Infosys Life Sciences: Transitioning for a healthier future

The life sciences industry is witnessing a transition that is influencing the approach towards healthcare. As organizations implement a patient-centric model, there is an urgent need to reinvent and find effective healthcare solutions. Infosys life sciences offerings are specifically designed to address the challenges faced by pharmaceutical, biotechnology, and medical devices companies.

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Infosys Pharma Regulatory Compliance

Pharmaceutical and life sciences companies are among the most heavily regulated industries in the world. However, the regulatory environment keeps changing. This is in response to the effects of globalization, emerging markets, new technologies, and rising demands of both patients and regulators. Infosys has a dedicated team of experienced professionals and a suite of service offerings that cater to an enterprise’s quality and compliance requirements.

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Infosys CRM offering leveraging Veeva

Veeva CRM package is a CRM solution developed for life sciences and biotechnology business processes. It is built on the SFDC platform and provides all the benefits of a cloud platform and a mobility solution.

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Infosys Clinical Trial Supply Management

Clinical trials are a critical phase in a long and complex drug development lifecycle. Infosys Cloud-based CTSM solution helps accelerates clinical trial supply management and lowers drug development costs.

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Pharmaceutical serialization track and trace

As more and more governments enact legislation requiring serialization of all pharmaceutical products to eliminate counterfeiting of drugs, several regional deadlines loom over pharmaceutical companies. Infosys Serialization Track and Trace pre-configured solution has been developed on SAP, using SAP components like SAP ECC, SAP Auto ID-Infrastructure (AII), SAP Event Management (EM) and SAP ITS Mobile.

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Complaint management solution

Complaint management is at the heart of pharmaceuticals and medical devices industry operations – it can save the business from undesirable costs and efforts while ensuring drug safety and viability of the brand. Infosys Complaint Management solution is built on SAP and integrated with HANA which helps customer support service function to handle customer complaints / issues / queries efficiently.

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Infosys Pre-configured SAP solution for medical device industry

The medical devices industry is a highly regulated sector of the economy. Infosys pre-configured solution (based on SAP ECC 6.0) has been certified by SAP as a Rapid Deployment Solution (RDS) and is listed at the SAP Store.

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