If your company utilizes clinical trials as part of its business model, then you know the importance and sheer necessity of tracking every invaluable piece of data that is gleaned from its respective studies.
Continue reading to learn more about why your company needs a new computer software package to manage your proprietary data and further your research to bring new results to market, find breakthroughs, and verify efficacy in existing results.
What Is a Data Management System?
A data management system is essentially a computer software package of programs that allows your company to fully track a clinical research trial. As the study progresses, the amount of data can become insurmountable. And, if you have multiple studies involving different demographics, participants, and potential outcomes running simultaneously, it can devolve into disorganization and chaos all too quickly.
Fortunately, there are productive and proactive ways to mitigate concerns during clinical trials from ever occurring. One of those ways is by implementing high-quality clinical data management systems or CDMS to tackle the need for accuracy and attention to detail.
The CDMS encompasses eight stages, which include:
1. Set up a plan.
2. Collection of data.
3. Assurances offered to validate data and quality of research meeting requirements.
4. Identifying potential risks or concerns throughout the trial.
5. Preserve and safeguard the data accuracy, consistency, and completeness.
6. Integrate varying datasets to evaluate information.
7. Evaluate data for reportable patterns.
8. Lock or stop new data and content from being entered into the system to preserve integrity.
Who Uses a CDMS?
Many companies use a critical system for managing their data as it is crucial for tracking protocols, data, and any other information involved in their respective processes; however, clinical data is generally tracked by companies including:
- Hospitals and health systems
- Pharmaceutical companies
- Teaching or academic medical institutions
- Medical device manufacturers
- Cancer treatment and research centers
- Clinical research entities
- Site networks and communities involved in clinical research
- Food test and development kitchens
- Cosmetic companies
Any companies that conduct trials involving participants will benefit from using a high-quality CDMS. It promotes transparency through research and data while confirming adherence to government and industry standards and guidelines.
What Does a CDMS Include?
A CDMS is broad in its range and depth of information collection. It encompasses every detail involved in a clinical research trial. This content collection begins with the idea or problem to research and study. It includes the programs or software used in the research to track participants, in addition to:
- Creating and managing desired software systems for the clinical trial.
- The input and maintenance of databases.
- The creation of proprietary processes involved in study creation and maintenance.
- Monitoring procedures to ensure protocols are followed according to policy.
- Tracking employee training so best practices are observed and implemented.
- Collection support and tracking.
- Monitoring of equipment and material cleaning and sanitization.
- Management of subjects involved in the study.
A comprehensive CDMS will track and document the financial aspects of a clinical research study, as well. This assists those in charge to determine the cost-benefit analysis of the study as it progresses.
Why Do You Need a CDMS?
When you run a clinical trial, you receive information. That information is vital and must be securely stored somewhere. Keeping your clinical research data organized and accessible is imperative to your trial’s success. It is, also, critical for your company’s continued success and reputation as compliance with protocols is required.
When your business and team can back up your claims with hard data, you have integrity. When your data is securely stored, it saves your company costs over the long term by reducing data loss.
A CDMS is like an extension of your team of employees. It provides support and clarity through its programming to make your job easier.
Keep Your Critical Data Under Control Through Effective Data Management.
A manager’s key roles are to effectively run and direct specific activities with the main purpose of achieving a set goal. A high-caliber CDMS will do the same thing for your clinical research trials by converging all information regarding the entire research process from inception to completion. It will include every piece of data pulled from the study to combine it with information that the researchers will use time and again to further their end goal and studies.
Data management is critical for managing complex situations by creating a central and unified place for everyone involved to go regarding the study’s elements.
When it comes to clinical research trials, managing your data effectively via the best systems should be your number one priority.
