Did you know that Phase III clinical trials create about 3.6 million data points, which is three times more than it did ten years ago?
For decades, the Phase III stage has been carried out in the same manner: It can span many years, involves up to 3,000 individuals, and takes place before the medicine or therapy method is approved. What is the reason for this sharp increase in data volume?
Large-scale drug development initiatives aimed at treating rare illnesses, using biomarkers and genetic information, and expanding patient data sources, including wearables and web-based surveys, are major drivers of this expansion. Clinical researchers must use this data and make the most of it, regardless of the reason. Clinical data management seems to have found a solution to this problem.
Clinical Trial Data Management – Overview
Clinical data management (CDM) is gathering and managing research data to comply with legal requirements. These guidelines guarantee accurate and comprehensive information of the highest caliber. Federal, state, and municipal regulations must be followed.
Clinical data management deals with data from clinical trials. Thus, all software systems, business processes, training, rules, processes, databases, and protocols must support the accurate gathering, cleansing, and administration of trial data.
Importance of Clinical Trial Data Management
Clinical data management is crucial because it guarantees the high quality of the data generated by clinical research. When done correctly, clinical data management produces a trustworthy, accurate dataset available for analysis at the end of the trial.
Additionally, CDM provides critical assistance for assessing regulated commodities, such as food, medical devices, medicines, and cosmetics. Compliance with regulatory requirements is required to ensure that your purchase items are secure and will function as intended.
Here are a few advantages that clinical data management provides:
- No data will be lost.
- Data integrity is ensured.
- Growth is accelerated.
- There is safer.
- The database correctly depicts the trial.
- Prices are decreased.
- Accurate and comprehensive data collecting is done.
- The data is well prepared for easy use.
- A tidy dataset is provided for reporting.
Main Objectives of Clinical Data Management
Streamline your Clinical Trial Data Management with ClinicalPURSUIT
Clinical trials are a complex process. They involve many different parties, including researchers, patients, and healthcare professionals. Clinical trials also require a lot of data to be collected and analyzed. This is why clinical trial data management is so important.
All of this information must be stored safely and securely. You want to make sure it’s accessible whenever you need it and that it can be used for multiple purposes. This is where ClinicalPURSUIT comes in!
ClinicalPURSUIT is an electronic data capture (EDC) system that helps easily manage your clinical trials. We offer everything from source data verification to randomization in clinical trials, so you’ll always be able to track what needs to be done next or who did what last week when it comes time for your report-writing meeting with the FDA!