Good data management solutions truly make a difference in terms of accelerating innovation in the life sciences fields. There’s no doubt that clinical trials generate a ton of information, but that data is useful only if it can be managed accurately and quickly. Learn more about the importance of having a solid data management system in place for your research efforts, in whatever biomedical, biopharmaceutical, or other life sciences business you may be in.
Data Management FSP
Every clinical trial is unique. Each study contains specific metrics that have been defined by the researchers, and the study goals vary from one trial to the next, even though the overarching goal is always the same: to discover new, innovative ways of helping patients.
A data management functional services provider (FSP) needs to first understand the overall goal of the clinical trial, as well as the specific metrics that have been put into place. Once the control and variables are understood, the services can be customized to meet each life sciences company’s needs.
Data management involves numerous functions; these include:
- CRF Design: The case report form (CRF) has to be developed to collect patient data. Whether the form is in print or makes use of electronic data capture, or both, it has to be developed carefully so that the right type of data is collected for the clinical trial’s success.
- Data Quality Control: In order for the data that’s collected to be meaningful, it has to undergo quality checks and balances. Even the data entry efforts need to be flawless. Other tasks include data listings, validation checks, query management, and user-acceptance testing. The success of the study depends on the quality of data collection and validation efforts.
- Clinical Trial Quality And Validity: For a clinical trial to yield meaningful results, certain measures need to be put in place. These include AE/SAE reconciliation, randomization, device accountability, proper metrics and reporting, accurate medical coding, and much more.
Let’s take a quick look at some of the elements that go into a reliable data management system for clinical trials.
Data Validation Checks
Has the interviewer gathered up accurate, valid, and useful data from each patient or subject? Have the data-gathering efforts remained consistent from one subject to the next throughout the entire clinical trial? Has the data been entered correctly? Data validation checks help ensure that these important safeguards are in place and that invalid data doesn’t accidentally skew the trial conclusions and results.
Listings, Entries, And Managing Queries
Are the data listings clear and decipherable? How simple is it for an interviewer or researcher to enter the data? Are the data query management functions user-friendly and simple to use? These functions are important, because when they’re implemented correctly, you’ll save a great deal of time and the entire process will be more streamlined, all of which can ultimately help you to accelerate your scientific innovation.
Proper, Quick Documentation
First, the data management documentation that’s provided needs to be well-written and well-organized. This includes the plan, data transfer agreements, case report form guidelines, and more. In addition, the study organizers and researchers need a way to access data quickly and share results in a manner that fellow researchers can comprehend.
Metrics And Reporting
We’ve already touched upon this, but we’ll say it again, because it’s so very important: Quality metrics are a must. Metrics will make or break your study. Start with a reliable, flexible data management system that lets you achieve accurate, relevant metric collection and analysis. With this solid system in place, you will be able to collect key data efficiently, analyze it more quickly, come up with accurate conclusions more readily, and report your findings with greater ease. All of this put together lets you get to your end goal faster, speeding up your business’s innovation by taking you from research and development to new medicines and treatments faster.
Reach Out to Emanate Life Sciences Today!
We work with pharmaceutical and other life sciences companies in San Diego, the Bay Area, and many other locations in California, as well as out of the state, to assist with the important task of data management. Our company’s data management functional services provider (FSP) service makes sure that your business or organization has proper oversight of all data management requirements.
Our team has a deep passion for the life sciences industry, and we take it upon ourselves to provide companies with the tools needed for success. Our mission is to support both small and mid-sized firms with their important clinical trials. We understand that industry innovation comes from these trials, and we’re poised to help you streamline your efforts through high-quality services, including secure, accurate data management. Our valuable services and commitment to quality make us one of the top clinical data management companies in the nation.
Reach out to us today to see how we can help your life sciences business enjoy higher levels of innovation and success!