Advanced Patient Randomization and Enrollment

Marvin RTSM/ IWRS:

In the competitive landscape of clinical research, efficient patient randomization and comprehensive trial supply management are pivotal for the success of your studies. Marvin RTSM (Randomization and Trial Supply Management) offers an automated, streamlined solution designed to ensure your investigational products are effectively randomized, distributed, and managed. Integrated seamlessly with Marvin EDC, our web-based platform provides real-time reporting, robust cohort management, and intelligent automation, enhancing both operational efficiency and data integrity.

Adaptive Trial Designs

Flexible Randomization Methods

Intelligent Supply Chain Management

Marvin your Study

At the heart of every Trial with Marvin is our deep understanding of modern complex trials. We understand your requirements and help you finding solutions during the entire trial.

Setup

Supports complex trials

Randomization

Full flexibility with different randomization methods

IPI Control

Optimize your investigational product inventory (IPI) and distribution

Gain Insights

Real-time reporting integrated into your dashboards

Powerful Randomization Capabilities, Natively Integrated

Features and Advanced Capabilities

Patient Randomization

Material Handling

Adaptive Trials

Advanced Patient Randomization and Enrollment

Patient Randomization

Support for adaptive Trial Designs - Accommodate innovative designs like basket, umbrella, and platform trials, streamlining drug development with flexibility and adaptability. Flexible Randomization Methods - Marvin’s randomization feature gives you full flexibility. Choose between site-based or cross-site block randomization, or opt for advanced algorithm-driven methods such as variance minimization, block-wise randomization or CARA - with the option to include various stratification factors for greater balance and precision.

Intelligent Supply Chain Management

Material Handling

Kit Code List Management - Upload and manage your Kit Code List to the central depot, defining kit allocation and treatment arms for each kit. This ensures accurate tracking and distribution of IP across all study sites, preventing shortages and overstock scenarios. Comprehensive Supply Schemes - Implement buffer and predictive supply management models, with the ability to alter plans in real-time based on study progression and site needs. Utilize pooling strategies to save on inventory costs and ensure that your supply chain remains responsive to study demands.

Addressing Adaptive Trial Challenges

Adaptive Trials

Maintain Transparency and Integrity - Use real-time reporting and audit trails to ensure all adaptations are documented and compliant. Manage Complexity and Resources - Support advanced randomization algorithms, integrate with statistical tools, and automate workflows to optimize resources. Ensuring Regulatrory and Ethical Compliance - Facilitate timely reporting to regulatory agencies with E2B safety notifications and integrated safety systems, safeguarding patient safety.

Seamless Integration and Scalability

Ensure RTSM fits into your clinical trial ecosystem and scales with your needs.

Integrated Platform

Embedded within Marvin EDC and SafetyEasy® streamlining processes with single sign-on and seamless data flow.

Flexible Deployment

Deploy RTSM as a standalone module or part of a comprehensive platform, scaling from small single-site trials to large global studies.

Interoperability and Compliance

Integrate with external systems using open APIs and standard formats like CDISC ODM XML and FHIR/HL7. Use SDTM-compliant eCRFs for faster regulatory submissions.

Compliance & Security by Design - Built on a robust, pre-validated framework aligned with GCP and 21 CFR Part 11 Standards.

Full Compliance with GCP and 21 CFR Part 11 Standards

Our solutions provide complete compliance with Good Clinical Practice (GCP) and 21 CFR Part 11, featuring secure eSignatures and audit trails that simplify regulatory audits and enhance research credibility.

GDPR-Compliant Data Handling and EU Data Storage

We host data securely within the EU, ensuring compliance with GDPR standards for academic institutions in Europe and securing sensitive patient data with SSL encryption.

Secure Audit Trails and Role-Based Access

Maintain detailed audit trails for transparency and role-based access control to safeguard against unauthorized access, ensuring that only approved personnel handle sensitive information.

Trusted by Industry Leaders

“By collaborating with the Marvin team over several years acromion’s data management team has acquired the skills and knowledge of implementing complex and challenging clinical protocols on Marvin, while adding its expertise in clinical data validation, safety reporting and CDISC competence to the final product. All the time we perceived a cooperative, fast and qualified partnership with the Marvin team.”

Oana Braun, Founder acromion

“We think that Marvin is very flexible. It allows us to manage very complex amendments and study design. It’s also very easy to integrate with external parties (using real web services and the REST technology).”

Benoît de Malglaive, Team Leader EDC Specialists, IDDI

“We are currently conducting six oncology studies using Marvin, including a Phase III study. We were quickly convinced by Marvin, as the system is extremely user-friendly. We particularly appreciate the modular structure, which can be flexibly tailored to the requirements of our studies. We don’t have to use all the modules, but it’s reassuring to know that everything is integrated. If something changes during the course of the study, the system can easily be adapted. Marvin has optimized our processes and is extremely user-friendly – it’s easy to navigate and provides everything you need.”

Michael Fuchs, Leiter Studienzentrale der Deutschen Hodgkin Studiengruppe (GHSG)

“I had worked at two companies involving EDC systems. We are lucky and honored that we are in the position using Marvin with our studies. Marvin is a marvelous system.”

Naoko Nakagawa, Data Manager, I’Cros Japan