
Literature review, reference management, postmarket surveillance, and regulatory intelligence – in one connected platform.
Literature
CiteSource
Pathway
ReadyView
Vigilance

Evidence Structured.
Insights Delivered
Take control of clinical evidence in one intelligent platform.
Manage All Clinical Evidence Workflow
A modern evidence platform connecting review, reference management, vigilance, and reporting across teams

Pathway
Intelligence
Give writers the context and clarity they need to turn clinical evidence into confident, compliant content.

CiteSource
Unified Library
All literature, references, and source documents – organized in one enterprise, review-ready library.

Vigilance
Safety Central
Manage safety data, detect signals early, and generate regulator-ready reports – all in a single platform.

Literature
Smarter Reviews
Streamline every stage of the review – from search to screening to structured output.

ReadyView
Submission Builder
Transform evidence into submission-ready documents using built-in templates and export tools.
Literature Challenges. Unified Solution.
Every department in a functioning life sciences company has their own unique priorities and headaches.
Executives of Medtech Challenges
Increasing global regulatory burdens
Need for oversight of productivity
Fierce competitor landscape
Rapidly changing customer needs
Evidence Cloud Solution
Product specific regulatory intelligence
Live team performance reporting
Active competitor monitoring and comparison trending
Publication monitoring and AI powered analysis
Clinical and Regulatory Directors Challenges
300+ Documents, 50% Less Staff:
Teams produce 300+ regulatory documents annually with 50% fewer resources than needed
Rejections Cost 18 Months:
Submission rejections cost 6-18 months in delays and $500K+ in rework
40 Hours Monthly Tracking Changes:
Regulatory changes across multiple jurisdictions create 40+ hours of research monthly
Email Chaos Delays Submissions:
Cross-functional collaboration through email chains causes 30% of submission delays
Evidence Cloud Solution
60% Faster Document Creation:
Automated literature search and citation reduces document creation time by 60%
Catch 95% Rejection Triggers:
Pre-submission quality checks catch 95% of common rejection triggers before filing
Weekly Regulatory Change Alerts:
Regulatory change alerts with impact analysis delivered weekly for all active markets
Eliminate Version Control Errors:
Centralized collaboration workspace eliminates version control errors and email chaos
Medical Writers Challenges
Wasted time managing searches:
Spending 15+ hours per week on literature searches instead of actual writing
50+ Versions, No Truth:
Managing 50+ document versions across email with no single source of truth
Unfamiliar Areas, Tight Deadlines:
Researching unfamiliar therapeutic areas with tight deadlines and minimal support
40% Time on Admin Tasks:
Administrative tasks consuming 40% of productive writing time
Evidence Cloud Solution
Save 12 Hours Weekly:
One-click literature search with automatic citation formatting saves 12 hours weekly
Real-Time Collaborative Editing:
Real-time document collaboration with automatic version control and audit trail
100+ Pre-Built Templates:
Curated regulatory guidance library with templates for 100+ document types
Automated Reference Management:
Automated reference management and formatting eliminates manual bibliography work
Marketing & Medical Affairs Challenges
Managing valid claims:
Complex Off-Label Response:
Off-label inquiries requiring 4+ hours of research per response
Manual Competitor Monitoring Misses Issues:
Competitor claims monitoring is manual and catches issues after market damage
Evidence Across 20+ Databases:
Clinical evidence scattered across 20+ databases with no central repository
Evidence Cloud Solution
Pre-Approved Claims Library Ready:
Pre-approved claims library with supporting evidence ready for immediate use
Off-Label Responses in 30 Minutes:
Off-label response templates with auto-populated clinical evidence in <30 minutes
Weekly Competitor Claim Alerts:
Automated competitor claim tracking with weekly alerts on new marketing materials
Unified Evidence Repository:
Unified evidence repository linking all claims to source documentation instantly
PMS and Vigilance Employees Challenges
Manual searches:
Manual vigilance database searches across 15+ sources taking days to complete
High stakes for missed events:
Missing reportable events results in average fines of $890K per incident
300+ Hours for Annual PSUR:
Annual PSUR creation requires 300+ hours of data compilation and analysis
Pattern Detection Months Late:
Complaint trending analysis is manual, catching patterns months after emergence
Evidence Cloud Solution
Automated Daily Vigilance Monitoring:
Automated daily vigilance monitoring across all major databases with smart alerts
100% Event Capture Rate:
AI-powered signal detection ensures 100% capture of reportable events
PSUR in 40 Hours:
PSUR automation reduces report generation from 300 to 40 hours
Detect Patterns 3 Months Earlier:
Real-time trending dashboards identify safety patterns 3 months earlier
Regulatory and Quality Employees Challenges
Managing 1,000+ Document Templates:
Managing 1,000+ document templates across multiple regulatory frameworks
180+ Markets, Monthly Updates:
Interpreting regulations from 180+ markets with monthly updates and amendments
Documentation Across 10+ Systems:
Quality system documentation scattered across 10+ systems
200+ Hours Audit Prep:
Audit preparation consuming 200+ hours of document gathering
Evidence Cloud Solution
Smart Auto-Populating Templates:
Smart template library with auto-population from master data sources
Side-by-Side Regulatory Comparison:
Regulatory interpretation engine with side-by-side comparison across markets
Unified Quality Documentation System:
Unified quality documentation system with instant search and retrieval
Audit Package in 2 Hours:
Audit-ready package generation in 2 hours vs. 2 weeks
R&D Challenges
50+ Sources for Safety Data:
Pre-clinical research requires searching 50+ sources for component safety data
6-Week Technology Assessments:
Technology landscape assessments taking 6+ weeks delay development decisions
Missing 30% Prior Art:
Patent and prior art searches missing 30% of relevant documentation
Unstructured Data Prevents Insights:
Unstructured research data prevents trend identification and innovation insights
Evidence Cloud Solution
500K+ Studies Instantly Searchable:
Comprehensive component database with 500K+ pre-clinical studies instantly searchable
Landscape Reports in 24 Hours:
Automated technology landscape reports generated in 24 hours vs. 6 weeks
95% Prior Art Capture:
AI-enhanced prior art search captures 95% of relevant patents and publications
Structured Repository Enables Trends:
Structured research repository enables trend analysis and white space identification
Internal Librarians Challenges
200+ Monthly Ad-Hoc Requests:
Processing 200+ ad-hoc literature requests monthly with 48-hour turnaround expectations
30+ Databases, No Visibility:
Managing subscriptions across 30+ databases with no usage visibility
10 Hours Weekly Procurement Tracking:
Manual procurement tracking consuming 10+ hours weekly
$50K Annual Duplicate Purchases:
Duplicate purchases costing $50K+ annually due to poor visibility
Evidence Cloud Solution
70% Fewer Ad-Hoc Requests:
Self-service portal reduces ad-hoc requests by 70% while improving satisfaction
Centralized Subscription Analytics:
Centralized subscription management with usage analytics and ROI tracking
Automated Procurement Workflows:
Automated procurement workflows with budget tracking and approval chains
Save $50K on Duplicates:
Duplicate detection saves average $50K annually in redundant purchases
IT Departments Challenges
15+ Disconnected Regulatory Systems:
Supporting 15+ disconnected regulatory systems with integration nightmares
Multiple Separate Compliance Audits:
Security compliance across SOC 2, HIPAA, and ISO 27001 requiring separate audits
5+ Hours Per User Access:
User access management across multiple systems taking 5+ hours per employee
Data Silos Prevent Analytics:
Data silos preventing enterprise-wide analytics and reporting
Evidence Cloud Solution
Replace 10+ Legacy Systems:
Single platform replaces 10+ legacy systems with native Salesforce integration
Pre-Validated SOC 2 & HIPAA:
Pre-validated SOC 2 Type II and HIPAA compliance with unified audit reports
SSO Provisioning in Minutes:
SSO and automated provisioning reduces access management to minutes
Unified Real-Time Analytics:
Unified data model enables real-time analytics and enterprise reporting
Intelligent Evidence Workflow
Automation, intelligence, and compliance — all in one unified platform.
Workflows
Reduce review time by 75%+ with intelligent screening and scoring
Knowledge
One system for access, sharing, and management of evidence
Compliance
Generate audit-ready documents aligned to global standards
Intelligence
Identify trends, signals, and risks and stay in front of them
Seamless Integration
Work seamlessly within the enterprise technology stack
Return on Investment
Lower cost, eliminate manual tasks, and accelerate submissions
90%
Faster
Built on Force.com platform powers workflow automation and compute elasticity, enabling productivity gains
30+
External Databases
Parallel ingestion and federated search via high performance cloud-native backend
Global Regulatory Management Platform
Built on Force.com to deliver in all phases of regulatory documentation
100%
Audit Transparency
Force.com platforms secure and compliant infrastructure, auto-captures a complete audit trail
6
Integrated Modules
Unified regulatory toolkit – modular, interoperable, and powered by Force.com
The questions we hear most often
The platform covers various processes and roles, so questions can vary from security to integration. We have collected short answers to the questions most teams are interested in at the start
Yes! All modules can work independently if you just need one use case.
The platform supports the preparation of CERs, PMSs, PMCFs, PSURs, Vigilance reports, and other documentation that meets MDR, IVDR, and FDA requirements.
All modules are designed to be useful within a single afternoon of work. No complex training process or on-boarding required (but available if your team prefers a formal workshop format)
We are built on platforms with the highest security and compliance standards (Salesforce and Heroku). Beyond that, we maintain substantial audit processes that can be read about on our trust page.
Data is stored in secure, SOC-compliant data centers according to standards set by GDPR, HIPPA, and all major data privacy standards.
14 days demo access
Evaluate the platform’s capabilities using your own worklfow
Get a demo access to CiteMed and test the functionality that suits your needs
Would you like to get a consultation? Contact the team