Regulatory Automation & Compliance Improvement Ensuring compliance with global regulations and streamlining life sciences data management future proofs your regulatory operations to manage adoption of the electronic Common Technical Document (eCTD4) standard for conducting regulatory submissions, which will become mandatory by 2028.
Targeted AI Enhancement How to combat fragmented clinical trial processes and low patient enrollment rates? AI-powered patient matching and enrollment accelerates clinical research and trials, engaging and retaining patients, while real-time CRA performance tracking and analytics helps to ensure participant safety and data integrity.
Commercial Operations Optimization Gain the ability to efficiently create and manage compliant, multilingual microsites that deliver strong digital experiences. Streamline driving data processing and analytics for Distribution Requirement Planning to gain insights on inventory movement, planning and obsolescence management. And tackle the integration hurdles that accompany the growth and innovation brought about by M&A activity.
FirstPoint RIM.AI 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.
Regulatory Submission Services Our Regulatory submission services Optimize business processes across the regulatory value chain. 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.
ClinicalWorks 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).
Clinical Development Accelerators 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.
Life sciences companies can speed regulatory approval with Gen AI 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. READ THE ARTICLE
Harnessing AI to revolutionize healthcare Learn about several exciting new AI-related clinical trials and research programs that promise to advance the prevention, diagnosis and treatment of disease. READ THE ARTICLE
Tackling the problem of antimicrobial resistance using AI and automation Singapore General Hospital is working with DXC to use AI to automate auditing antibiotic usage. READ THE ARTICLE