With the pressure on for earlier, faster clinical trial results, clinical data management systems (CDMS) must keep up, with quick deployment, incisive data analytics and increased automation.
The costs of clinical trials keep rising, and budget and market pressures mean that sponsoring organizations want fewer trials, with as much research packed in as possible and faster data analysis and results. Patient, ethical and regulatory demands keep increasing, with clinical trials sometimes extending post-marketing. There’s marked growth potential for clinical trials, and users are looking for feature-rich, flexible technologies to manage the entire process. Organizations also want results earlier in a clinical trial than ever before, and maturing technology can help get those results and make immediate changes in response.
Electronic data capture (EDC) technology supports more complex trials, and collects data from a wide range of sources. Technologies around clinical data management are moving toward a more holistic approach, with integration of CDMS and EDC systems, and the availability of software suites around clinical trial management. CDM systems are adding automation around protocol design, and working to eliminate user errors and redundancies throughout the entire trial process. Hosted and on-demand options are available, as are outsourced options with contract research organizations (CROs).
Best-in-Class Clinical Data Management Systems Features:
- Ability to link and share records with other systems, and facilitate integration or interoperability across data sources
- Supports global outsourcing with constant tech support and business continuity plans for clinical trials
- Analyzes data and performance metrics in real time to allow for speedy decision-making and trial adjustments
Top Considerations Before Buying Clinical Data Management Systems:
An effective clinical data management system should be highly available and scalable. As the clinical trial market becomes more competitive and demanding, software should keep up, with capabilities like interactive voice and web response, intelligent protocol design and real-time progress tracking. A fully integrated clinical infrastructure is the next step, offering a holistic view across trials and data sources, and minimizing redundancy and the possibility of error. CDM systems should support new developments in trial design, meant to identify failures at an earlier clinical trial stage. Users should be able to access productivity and performance metrics quickly and easily. Technology adoption will continue as clinical trial management becomes more complex and more important.
Key Products:
1. BioClinica delivers electronic data capture, medical imaging management and data management solutions for clinical development life cycle. The BioClinica Data Management service is run by clinical data managers to help capture clean, accurate trial data. BioClinica Express is an electronic data capture system that provides a central hub to collect and manage clinical trial data, with easy data import and export. BioClinica IVR/IWR incorporates interactive voice response and interactive web response information into clinical trial data.
2. Phase Forward provides integrated data collection and data management solutions for clinical trials and drug safety. Phase Forward’s Clintrial is a clinical data management system that collects, manages and reviews clinical data. InForm GTM, an electronic data capture (EDC) system, is a set of reporting and analysis tools let sponsors view and act on data as soon as possible in the trial development. Phase Forward’s WebSDM tool lets users test FDA submissions for compliance and integrate clinical datasets from various sources.
3. eClinical Solutions, a division of Eliassen Group, provides a team of clinical data management, training and consulting experts who facilitate and expedite electronic management of data in clinical trials for pharmaceutical, biotechnology and medical device companies. eClinical Solutions provides data management services, EDC
services, Statistical programming, training and reporting solutions, user acceptance testing (UAT)/validation services, as well as clinical data repository solutions. Their service offerings include functional outsourcing, staff augmentation or project solutions.
4. StudyManager provides clinical trial management software (CTMS) and EDC solutions to organizations that sponsor or conduct clinical trial research. StudyManager brings all critical trial data into the same system, and offers site progress tracking, productivity and tracking reporting, payment tracking, enrollment data monitoring and direct database access. Their Sponsor Edition (SE) software, designed for rapid deployment, is ideal for smaller or early phase trials, and for trials with budget constraints. Tools are available on demand and backed by consulting and other support services.
5. Medidata is a global provider of hosted clinical development solutions that streamline the design, planning and management of key aspects of the clinical development process, including protocol design and development, investigator benchmarking and budgeting, contract research organization benchmarking and budgeting and the capture, management, analysis and reporting of clinical trial data. Medidata Designer automates protocol design, using previous studies and company standards, and reduces the possibility of manual errors during clinical studies.
Clinical Data Management Systems
Definition: Clinical data management systems are used in clinical research to manage the data of a clinical trial. Also referred to as CDMS, clinical data management systems store the clinical trial data gathered at the investigator site in the case report form. CDMS reduce the possibility of human error by using different means to verify the entry, the most common method being double data entry.
