A clinical data management system is a tool used to manage all the data generated in a clinical trial. An effective CDMS is specialized software that streamlines data collection, storage, validation and reporting from various sources, ensuring accuracy, compliance and reliability. A CDMS is a clinical trial technology solution that is critical to simplifying processes for research teams as well as ensuring data quality and regulatory compliance in clinical trials.
What Does a CDMS Do for Clinical Trials?
Without a doubt, an effective CDMS matters in clinical research.
At a high level, the CDMS performs four functions:
- Streamlining data workflows
- Enhancing accuracy and reliability
- Reducing time to database lock
- Supporting decentralized and hybrid trials
More specifically, the CDMS manages:
- Data collection from various sources, including electronic case report forms (eCRFs) and various electronic systems
- Data storage in a secure and structured database
- Data validation with edit checks and other quality control measures
- Data management of the entire data lifecycle, including cleaning, transforming and preparing data for analysis
- Reporting and analysis
- Audit trails that track all changes to the data and ensure data integrity
Key components of a CDMS are database management, data cleaning and validation, data integration, reporting and analysis, and security features.
What to Look for in a CDMS?
At OpenClinica, we have a history of publishing guides to help trials choose the clinical research technology solutions best suited to their research.
Feel free to check out two guides for optimizing your selection of an EHR-to-EDC solution and one for choosing the best technology partner for decentralized clinical trials (DCTs).
- EHR-to-EDC
– Choosing the Right EHR-to-EDC Solution for Clinical Trials
– The Electronic Data Capture (EDC) Checklist - Decentralized Clinical Trials (DCTs)
– DCTs: Finding the right technology partner
It’s within this context that we offer some insight into what to look for in a CDMS. The top five aspects to consider are:
- A user-friendly interface
- Regulatory compliance
- Scalability and flexibility
- Real-time access and analytics
- Vendor support and training
How OpenClinica’s Clinical Trial Technology Solutions Supports Modern Trials
OpenClinica’s clinical data management system (CDMS) scores high points from users for its user-friendly approach, its scalability and flexibility, on-demand access and analytics, support, training and regulatory compliance.
OpenClinica’s end-to-end clinical trial technology solutions are trusted by more than 1,000 customers and 20,000 clinical trials across 100+ countries. That’s because OpenClinica engineers better data, faster.
Our EHR to EDC eSource solution, Unite, automates source data acquisition from patient medical record systems (EHRs and EMRs) to clinical trial research databases (EDCs) and case report forms (eCRFs) at scale. This secure bridge between healthcare and research eliminates manual data transcription and is especially suited for rigorous GCP and Part 11-compliant clinical trials. Unite is backed by a rapidly growing network of over 450 clinical trial sites across major health systems serving tens of millions of patients.
Speed, quality and safety are some of the benefits of eSource. To read more about the nine advantages of OpenClinica’s EHR-to-EDC platform, click here.
Just as importantly, OpenClinica clients are satisfied.
Adam P, a data manager, wrote:
The support provided by the OpenClinica team cannot be beat. If I may list two things, the OC system is incredibly user friendly. We needed a centralized system to collect questionnaire responses from participants, record that data, enter clinical results, and upload copies of paperwork related to each participant visit. This system provides all of the above.”
John R., senior director of clinical research, wrote:
Overall: We’ve enjoyed a very strong relationship with OC. They are very supportive of our changing needs, and this solution provided robust core EDC system as a very cost effective option for our growing data management programs. Their trainers and programming consultants have been exceptional at helping us learn and navigate the system. The customer service has been exceptional.”
To read more client reviews, click here and to read about OpenClinica Recruit’s track record of customer satisfaction, click here.