Data Management (DM)

RodanoTech highly skilled DM team provides comprehensive Data Management and eCRF design services to the pharma industry and CROs as well as academic research organisations.

We assist you with any size study, from small Phase I studies to large-scale trials involving sophisticated designs and long-term follow-up across clinical settings and geographies.

We work in collaboration with your preferred CRO or one of our partner CROs to combine the full range of services needed for the execution of your study.

RodanoTech DM team takes care of all aspects of the data collection and validation:

• eCRF design and validation
• Development of the Data Management Plan
• Edit Check programming and testing
• Clinical Database Creation and Validation
• Medical data coding (WHO Drug and MedDRA)

• Data transfers (Lab, ECG, PK, Diary, etc)
• Reconciliation of external data
• Continuous Data Cleaning Throughout Study
• Development of Custom Status Reports
• Database Lock

Electronic Data Capture (EDC)

RodanoTech develops your eClinical solutions using our powerful yet simple to use Clinical Data Management technology designed to accommodate small Phase I clinical trials up to large interventional studies and observational registries.

We setup your study portal in a matter of a few weeks, including study specific workflows and branding. Protocol amendments are integrated anytime during the study course.

RodanoTech Electronic Data Capture services includes:

• eCRF setup and validation
• EDC operating (hosting, technical support)
• Experienced team at a competitive price

RodanoTech EDC solutions integrate all features to support the clinical trial processes, including:

• Dynamic eCRF with conditional logic
• Automated edit checks, query management, full audit trail
• Real-time monitoring of study progress, including site and patient recruitment, data management status…
• Graphical representation of clinical data (key feature for long term studies)
• Dashboard, graphs, data export facilities

• File cabinet for sharing study documents
• Flexible Source Document Verification up to the field level
• Event-driven notifications and alerts
• Fine-grained user profiles and authorizations
• Hosting in a highly secure data center with high speed redundant connections to the Internet

Registries, Medical eCommunities

RodanoTech has developed an innovative concept of online Medical Community platform designed for health care professionals sharing a common scientific interest. The RodanoTech eCommunity platform provides researchers worldwide with an easy solution to collaborate, collect data, share data, and join or create study groups freely.

The RodanoTech eCommunity platform is ideally suited for:

• Registries, Post-Marketing Studies, Disease Management Programs
• Rare disease
• Chronic diseases requesting a long term follow-up

The RodanoTech eCommunity platform integrates flexible collaborative tools that stimulate interactions between participants, including:

• Benchmarking
• Study groups
• Study group specific CRF
• Patient history data visualization tool
• Longitudinal follow-up of Patient through studies

The most successful implementation of the RodanoTech eCommunity concept is the MSBase Registry in Multiple Sclerosis. The project was initiated in 2003 and has rapidly become the leading international collaborative research platform in the fields of MS.

Electronic Medical Records

Healthcare professionals need to collect clinical data in a structured format. The hospital information systems are generally more suited for the administrative management of the patients and health case professionals, and often constitute weak solutions for the clinical monitoring of specific diseases in particular for long-term, chronic diseases.

A disease specific Medical Record is the answer.

The eMR built by RodanoTech includes many useful features such as:

• Powerful, yet simple to use
• Multi-user, networked database
• Desktop or web-based solutions

• Patient history data visualization
• Multilingual
• Connected to a Registry platform (optional)

Traditional EDC systems are bloated solutions. Overly complex, rigid, slow, costly and generally not easy to use for the end-users. RodanoEDC is an outstanding, new generation Clinical Data Management System ideally suited for electronic and paper based data capture.

The following features and more are available through an intuitive web interface:

RodanoEDC is a cloud based solution. This delivery model allows you to save the costs for setup and maintenance of your own IT infrastructure.

Your studies are hosted in a highly secured data center with high speed redundant connections to the Internet. The servers are monitored 24/7 in order to deliver the best service for users around the world.