Book a demo
Book a live 1:1 demo with one of our expert.
Trusted by 200+ Clients Worldwide
7 500+ Clinical Trials
Simplified Clinical Trial Management
100% Compliant and Secure Solution
A Complete and Agile Platform
How Rumb, a CRO, Supports Innovation in MedTech Through the Digitalization of Clinical Investigations.
We were looking for a solution that reflects who we are: modern, flexible, and capable of adapting to the diversity of our projects.” - Véronique Saunier, Clinical Investigations Coordinator
Rumb is a CRO (Contract Research Organization) specializing in digital and connected medical devices, founded in 2021 by a physician and industry expert. With cross-disciplinary expertise in clinical affairs, regulatory compliance, and digital health, Rumb assists MedTech and e-health startups and SMEs in achieving regulatory compliance to access markets in the EU and globally. Leveraging a deep understanding of technological and public health challenges, Rumb designs and manages complex clinical investigations tailored to the specific needs of each project, while incorporating applicable regulatory requirements and the expectations of health authorities.
Context & Challenges
Addressing the Growing Complexity of Clinical Investigations
Rumb initially relied on traditional data collection methods, combining paper CRFs with some sporadic digital tools. However, these practices quickly reached their limits as the complexity of coordinating and managing clinical investigations increased.
Manual updates to forms, managing duplicates, and systematic archiving created a significant logistical burden, complicating the traceability of changes. This approach consumed resources and increased the risk of errors during data entry and review.
A critical question arose: should Rumb systematically recruit data managers with advanced technical skills to ensure data quality, or could the structure of projects be rethought to improve the reliability of work methodologies?
Additionally, digital medical devices posed a unique challenge: data interoperability. Effectively integrating device software with data collection tools and required measurement parameters meant managing several complex variables simultaneously, often requiring custom development.
Why Rumb Chose Datacapt
Rumb selected Datacapt as a strategic solution to transform its data management processes. The goal was to simplify internal workflows while ensuring regulatory compliance and enabling clinical teams to directly configure forms (eCRF or ePRO) without relying on external development.
Datacapt provides an integrated platform combining eCRF, ePRO, automation, and APIs. It facilitates real-time data integration, eliminates manual entry, and enhances result reliability. Its 100% no-code approach that allows teams to create custom forms internally without technical complexity while adhering to regulatory standards such as FDA 21 CFR Part 11 and European and national norms.
Karim Nadra, Clinical Evaluations Manager at Rumb, was already familiar with Datacapt from previous experiences. His positive feedback confirmed that the solution met the demands of complex projects without requiring additional recruitment.
The solution
Implementation and Adoption - Gradual Integration for Rapid Skill Development
The implementation of Datacapt was carried out progressively through three structured training sessions. From the very first session, the creation of an eCRF and an ePRO was initiated, and within a few days, an initial version of the study, complete with structure, automation, and APIs, was configured.
The full configuration and validation process, including testing, feedback, and adjustments, spanned several weeks. This methodical approach allowed for gradual skill development and the adaptation of tools to the specific needs of each investigation.
One of Datacapt’s strengths was its ability to significantly reduce administrative workload without compromising scientific rigor. Tasks that previously took months to complete, such as finalizing data collection systems, could now be accomplished in just a few weeks.
This new workflow enabled teams to focus on what truly matters: data analysis and protocol optimization. Instead of spending time on administrative tasks and data validation, they could dedicate themselves to the strategic and scientific dimensions of their projects.
Tangible benefits – Efficiency, Traceability, and Operational Agility
The benefits of Datacapt became evident shortly after deployment, delivering substantial time and efficiency gains. Within just one hour of training, administrators could create forms, and in a matter of days, an initial version of the study—including eCRF, ePRO, automation, and APIs—was fully configured.
This swift setup reduced the preparation time required before starting investigations while minimizing low-value tasks such as managing Excel spreadsheets or manual data reentry.
Data collection and traceability were also enhanced. Every action is documented, every update is visible, and data is secured at every stage. Moreover, the real-time visibility provided by dashboards enables immediate tracking of study progress, including inclusions, queries, and data consistency.
Finally, the tool’s adaptability, without relying on external providers, offers valuable agility to meet the evolving needs of projects.
"Thanks to Datacapt, I’ve expanded my skill set. The solution adapts to the specificities of our projects while ensuring the rigor required for clinical evaluations."
Conclusion
A Structuring Tool for a Sustainable Partnership
The integration of Datacapt marked a pivotal step in Rumb’s management of clinical investigations, improving data traceability and simplifying administrative tasks. The tool optimized internal processes while flexibly adapting to the field’s requirements with attentive and responsive support.
Datacapt has become a structuring solution aligned with Rumb’s values of agility, methodological rigor, and autonomy. It effectively meets regulatory imperatives while reducing the workload for teams and fostering the development of their skills
