New Standard for e-Clinical Solutions
Integrated Platform for Faster, Accurate Clinical Data Aligned with Global Standards
Flexible, intuitive, and secure
EDC & cDMS Solution
Enabling easy collection,
validation, and reporting of clinical trial data.
Enhance accuracy and efficiency in data
management with our web-based platform.
MediLake: Designed for simplicity and reliability, so you can concentrate on accurate outcomes
Feature
UI-Based Design
Easily design studies without any coding or design skills,
and use immediately without additional app installations
Audit Trail
Full audit trail functionality meeting industry and national regulations
Coding Support
Integrated medical coding modules supporting MedDRA, WHO-Drug, and global standards
RTMS / IWRS
Efficient randomization and IP inventory control
for your clinical trials
Benefits
Effortless for every user
Optimized for Simplicity
in Clinical Trial Operations
Flexible
Adapt your research environment flexibly
to any clinical trial protocol
Dependable
Reliable Security and Regulatory Compliance
Fulfill all requirements
for PMS studies
MediLake PMS is developed to support
Postmarketing Surveillance (PMS)
Seamlessly integrated with MediLake EDC & CDMS,
delivering the full power and flexibility of eCRF
Empowering data managers, project managers, and clinical staff
with intuitive tools, comprehensive monitoring, and reporting
— saving time and effort
Feature
Adverse Event Management & Reporting
Manage and report adverse events
with options to include additional data for regulatory submission
Query Management
Fully utilize MediLake EDC’s query process,
with the ability to resend queries to site users
Provides reporting functionality based on PMS
Access PMS-Specific Dashboards and Reporting Seamlessly
Progress management & integration
Seamless Integration with External Progress Management Systems
Benefits
Streamline the PMS process
“Manage data, processes, reporting, and review
in one application
— fully compliant and audit-ready.
Easily follow study progress
PMS-specific dashboards plus external system
integration for full oversight and trust
Ensure transparency and accountability
Effortless review setup between sites and sponsors
through flexible query management
Reliable randomization.
Effortless supply management.
Simplify complex trials with MediLake IWRS
— integrated randomization and drug supply management
Accurate and efficient clinical trials made easy with MediLake
— flexible, reliable, and simple to set up
Feature
Streamlined randomization and kit management via intuitive design
Flexible, user-friendly
randomization and assignment form design
Supports both static and dynamic randomization :
Flexible randomization: manual lists or automated flows,
fully aligned with study protocols
Real-Time Inventory Monitoring
Flexible inventory management across studies and sites
Real-time dashboards for a complete view of inventory levels
Seamlessly integrated with MediLake EDC/CDMS
Reduce redundancy, ease adjustments, and minimize administrative workload
Benefits
Adaptable to your way of working
Streamlined and flexible randomization and allocation to match protocol needs
Capable, easy-to-use, and affordable
Optimize clinical trial logistics while reducing time and costs
.
Always stay informed
Monitor inventory effortlessly and
ensure timely resupply for uninterrupted trials
Powerful documentation management
MediLake eTMF is a fully integrated document management system, designed for fast, secure, and role-based access to all documents
Built on industry standards with configurable permissions, document review, and customizable structure, MediLake eTMF makes document management easier, smoother, and faster
Feature
Simplified TMF Setup
Easily create and organize TMF structures,
supporting CDISC TMF Reference (DIA) models.
Efficient TMF Management
Role-based access to prevent errors and
simplify user permission management.
Full transparency and trusted reliability
End users can upload, access, review, approve
, and sign documents in a single interface
Full transparency and trusted reliability
Benefits
Effortless
The simplest system for clinical trial documents,
delivering both efficiency and reliability
User-friendly structure management
Easily build document management structures
Easily capture data
directly from study participants
MediLake ePRO & eCOA streamline the process of collecting data directly from clinical trial participants.
Secure and seamless data collection across all devices — no data stored on participant devices.
Intuitive, participant-focused design to drive engagement and capture high-quality study data
Feature
Access and participate from any location
MediLake ePRO allows participants to easily access
the study via a web-based mobile interface on any device
Seamless ePRO Integration
Built on the same data repository as MediLake EDC/CDMS, providing an integrated structure that ensures data consistency and supports efficient electronic patient reporting
.
Adaptable for self-reporting and on-site assessments
Supports flexible combination of visit-based and self-reported assessments,
with configurable email and SMS notifications.
Benefits
Improve data quality
Allows participants to enter data directly,
enabling more accurate and comprehensive data collection
Secure, compliant data capture
Direct EDC integration for safe, device-free data handling
