“This solution makes such a difference in how quickly we can process documents for all types of regulatory applications. DXC ToolBox reduces our processing time by 50%.”
Jennifer Harmon, Associate Director of Regulatory Publishing at Quantum
Pharmaceuticals, biotech and medtech companies are determined to tackle tough challenges to help people around the world. Bringing new medications to market faster, for example, is a prime goal, but no easy task under the pressures of evolving global drug regulations, and data silos and legacy systems that limit analytics and insights. Difficulties around conducting trials for drug safety and supply chain inefficiencies also can be obstacles.
Software solutions for Life Sciences and Life Sciences platforms that bring AI, analytics, pharmacovigilance automation, pharmaceutical compliance, patient engagement, quality management and supply chain visibility are key to solving these and other problems. With DXC Life Sciences companies can innovate efficiently, make evidence-led decisions and bring medication to patients with confidence.
IT solutions for companies in the life sciences sector, such as those in the pharmaceutical industry, must be agile. That includes incorporating AI services, IoT and other advanced capabilities in order to accelerate innovation, improve the quality of submissions and of the patient experience, and enhance efficiency and quality in supply chain and manufacturing processes. DXC delivers full-stack capabilities across applications, data, AI and infrastructure, including cloud migration and cloud solutions for healthcare and life sciences; industry-specific platforms and accelerators; pharmaceutical software solutions; life sciences analytics software; and customer engagement platforms among its products and services for pharma, biopharma, medical device and other companies addressing challenges related to health and well-being.
Our comprehensive suite of Regulatory business automation software and services includes FirstDoc, TRS, Writer and ToolBox. Together with FirstPoint they deliver an AI platform for life sciences that automates regulatory workflows for global compliance; improves operational efficiency and reduces time-to-market; streamlines data management to enhance insights and decision making. As an orchestration layer, FirstPoint, can generate documents in multiple languages using Generative AI; automate document quality check; and achieve faster insights from complex data with AI-led bioinformatic and statistical support.
Our Regulatory submission services optimize business processes across the regulatory value chain, including readying your organization for electronic Common Technical Document (eCTD) 4.0. DXC’s teams of regulatory submission experts will ensure that your life sciences organization achieves fully efficient, end-to-end submission processes. Your business will maintain compliance with country or regional regulations in multiple markets, covering document formatting, document publishing, dossier publishing, submission filing and archiving. We provide flexible and extensive electronic Common Technical Document (eCTD) capabilities to the FDA/EMA and other agencies worldwide. DXC can tailor our service options and solution models to support clients’ individual needs.
Our packaged pharmacovigilance software solutions manage adverse drug reactions for a wide range of products, from prescription drugs to OTC medicines. An expanded workflow includes direct reporting to overseas regulatory authorities, input from overseas pharmacovigilance departments and support for Periodic/Aggregated Reports. Address process control for post-marketing surveillance, and tracking/reporting for adverse events such as drug reactions. Doing so supports effective alternative dispute resolution (ADR) case management and enables International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Accelerating drug and therapy development, and bringing innovations to market faster, benefit from our accelerators. Among our offerings, our accelerators leverage intelligent key performance indicators powered by AI to capture and synthesize edge to core data from multiple sources and convert it into meaningful dashboard and analytics in real time. They open clinical trial information platform for clinicians and research specialists to enable matching eligible patients with available trials. They also catalyze advanced database and analytics to enable accelerated clinical research and genomics correlation.
Pharmaceutical companies can now automate regulatory information management [RIM] workflows, reducing the potential for errors to appear in documents they must submit to obtain regulatory approvals.
Learn about several exciting new AI-related clinical trials and research programs that promise to advance the prevention, diagnosis and treatment of disease.
Singapore General Hospital is working with DXC to use AI to automate auditing antibiotic usage.
Jim Maher
U.S. Healthcare Portfolio Leader
Hiranya Bharadwaj
Life Sciences Industry Lead
David Rimmer
CES - Global Industry Lead
DXC RIM.AI helps you accelerate regulatory submissions for new therapies, devices and medicines in global markets. FirstPoint RIM.AI product suite is used by 500+ clients globally for their regulatory submissions. To cite just a couple of examples, among our clients we have seen zero refusal to file (RTF) for on-time, within budget submissions, and15% productivity gains on IND/NDA application compilation, submission and regulatory approvals. With our Total Regulatory Solution Suite, you can simultaneously publish and submit new drug applications in multiple markets and in compliance with a variety of regulatory formats, saving time and increasing productivity.
DXC Clinical Development Accelerators help life sciences organizations optimize clinical trials. Outcomes to expect from our Clinical Development Accelerators are:
AI can make multiple contributions to drug development and discovery, from analyzing large biological data sets to identify potential drug targets, to performing virtual screening for finding molecules suitable to becoming drugs, to finding new uses for old drugs. It can help lower costs by reducing failed experiments and trials.
DXC combines our domain knowledge in pharma / regulatory / clinical trials with AI/data/automation consulting. Among our consulting engagements, we have helped pharma companies accelerate regulatory processes using generative AI, and improved the efficiency of clinical trial design and operations using analytics and AI techniques. Overall, we have a strong ability to provide AI consulting in life sciences, especially around regulatory affairs, clinical trial operations, real‑world evidence, advanced analytics and enterprise modernization.
DXC provides a pharmacovigilance technology solution called ClinicalWorks. It is a pharmaceutical safety information management solution specifically designed for the pharmaceutical industry, for Adverse Drug Reaction (ADR) Tracking and Reporting. It supports compliance with domestic and international regulations (EMA, FDA, etc.) and supports both cloud and on-premises formats. This package is a condensation of the knowledge that DXC has supported in the pharmaceutical field for nearly 30 years.
We are in the process of expanding DXC ClinicalWorks, which has proven its effectiveness in Japan, to other markets. It is launching in the EU this year, and following that to the US, China, South Korea and Taiwan. Our global rollout features multilingual support.
You can file all at once across priority markets instead of waiting for approvals one by one, leverage accelerated pathways like the FDA’s Fast Track and submit pre-submission dossiers. AI tools and services from DXC can help you automate regulatory submission prep and manage different dossier formats. When it comes to the supply chain aspect, you can pursue cold chain readiness for temperature-sensitive biologics. DXC can support many of your efforts, including helping you coordinate real-time supply and demand globally.
