Achieve Up to 80% Automation of
Aggregate Reports & PSMFs
Quark empowers the world’s largest pharmaceutical companies to automate the
production of their highly regulated or complex documentation, so they can
approve and publish it faster, and stay compliant.
Streamline global PV reporting with AI-driven automation, seamless data
integration, and regulatory-grade accuracy.
“Quark brings to the table an innovative component content management system (CCMS) in Quark Publishing Platform, which leverages generative and semantic AI to automate the creation and updation of PSMFs and aggregate reports. Its ability to integrate with safety databases and signal management systems to pull in both unstructured and structured data in real-time, ensuring compliant and timely safety reporting, is what the highly regulated life sciences industry really needs.”
— Dr. Nimita Limaye,
Research VP, Life Sciences R&D Strategy and Technology, IDC.
Pharmacovigilance teams operate under high stakes – accuracy, compliance, and speed aren’t optional. But fragmented systems, manual workflows, and regulatory deadlines make every safety report a struggle. Quark makes it simpler.
Quark Publishing Platform (QPP) is a cloud-based, AI-powered component content management system (CCMS) purpose-built for life sciences. Designed to meet GxP compliance requirements, QPP gives PV teams full control over structured content creation in a secure, validated environment.
Use familiar tools like Microsoft Word with built-in automation and integrations to your data sources. Centralize, streamline, and accelerate the creation of essential safety documents — from PSMFs and PSURs to RMPs, DSURs, and more.
You’re Not Alone in These Challenges
“We spend more time chasing emails and aligning versions than analyzing the actual safety data.”
“Manual formatting in Word and Excel costs us hours per report, and still leads to QA issues.”
Top Use Cases Quark Automates
Pharmacovigilance System Master File (PSMFs)
PSMFs are among the most complex to automate. These documents require annual audits and must reflect all organizational activities related to pv compliance. Specifically, Section 16, which covers safety updates, is particularly difficult due to frequent updates required (annually or semi-annually) and the depth of tracking needed across global systems.
Periodic Safety Update Reports (PSURs)
These documents focus primarily on safety data, and involve extensive data retrieval and formatting. Whilst some aspects can be standardized, it’s not so straightforward when it requires medical judgement and narratives from a human, making the degree of compliance a concern.
Development Safety Update Reports (DSURs)
DSURs are primarily used during clinical development phase and can be complex due to data pulled from different sources. Subsequently, cross-functional collaboration becomes time-consuming and tedious.
Periodic Adverse Drug Experience Reports (PADERs)
These documents are created for post-marketing adverse events. They are fairly complex to manage due to narrative summarizations and regulatory context still requiring oversight.
Periodic Benefit-Risk Evaluation Reports (PBRERs)
PBRERs are comprehensive documents that must rely heavily on correct data pulled from various sources, formatting, analysis, interpretation, and strategic recommendations sections. The volume and diversity of data, including real-world evidence, make automation extremely difficult.
Risk Management Plans (RMPs)
RMPs outline a product’s risk profile, mitigation strategies, and post-market commitments. Automation becomes challenging when considering strategic planning which is highly contextual.
Top Challenges We Solve
AI You Can Trust — Built for Pharmacovigilance
AI can transform PV documentation – but only when it’s secure, explainable, and GxP-ready. Quark as an AI-powered content automation solution delivers just that:
Operates only on your internal data, hosted securely on Microsoft Marketplace
No external data sharing – ever – without your explicit permission
Full integration flexibility with your own LLMs or private AI tools
Developed and deployed in GxP-compliant environments, with full validation support
What Quark AI Enables for PV Teams
Validate safety documents and ensure data consistency across global submissions
Automate repetitive tasks like keyword tagging and narrative first-drafts
Deliver consistent search results and translate content across markets
Tune prompts, train teams, and maintain transparency and traceability at every step
