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Data Management Technologies - In-depth

In the clinical trial process, there is a substantial amount of data that is collected and analyzed for reliable end results. The existing paper-based system is inefficient and can prolong the development process and delay providing patients with effective treatments that could improve their well-being and even save their lives. DDA Medical offers innovative Internet-based eClinical trial data management systems for pre-clinical studies through Phase 4 trials to sponsoring pharmaceutical and biotech companies and medical device manufacturers.

 

Paper-based Clinical Trial Data Management System

Exam data recorded on patient chart --> Information manually transcribed to paper Case Report Form (CRF) --> Clinical research assistant from sponsoring organization collects CRFs --> Data manually entered into clinical data management system (CDMS)

 

Cons:

• In a paper-based system, the process of collecting information from participating physicians, laboratories, data reading centers, and contract research organizations can last a long time, which is time wasted in what is often the most expensive phase of the development process.
• Study files must be kept in fire-proof storage rooms or cabinets whose access must be controlled and permitted only to authorized team personnel. Consultation on paper files is only possible by physical extraction at the office location.

Online eClinical Trial Data Management Solutions

Electronic processes are used to collect, access, exchange, and archive data and documents required for conduction, management, analysis, and reporting of the trial.

 

Pros:

• Information management tools, every site contact report, document collected, monitoring visit report, patients’ enrollment, delay in eCRF forms compilation, queries solved and outstanding, and study metrics are available 24/7 anywhere in the world through an Internet connection.
• All digitized documents are securely stored and their accessibility is protected by encrypted transmission. Documents are immediately available to those authorized at any time.

Effective, efficient, and exclusive, our electronic data management technologies and services bring new meaning to eClinical trials so that you can bring your products to market quickly and safely. Our online systems facilitate and accelerate clinical trial development by supporting business and data management processes on our HIPAA-compliant servers. From remote electronic data capture and clinical data management to real-time patient enrollment, patient reported outcome, and registry withdrawal, our sophisticated proprietary software technologies present a significant advantage in terms of time from data generation to data cleaning and ultimately data lock. DDA Medical’s eClinical trial data management solutions are changing the face of pharmaceutical, biotech, and medical device research and development.