Today, the importance of harnessing clinical trial data has never been more relevant. Heathcare practitioners strive to deliver therapies that improve the lives of patients. However, the clinical data we produce can significantly impact our success in accomplishing this goal. A high-quality clinical data package is an important requirement for a new therapy to acquire approval from regulators like the EMA (European Medicines Agency) or FDA (Food and Drug Administration), as well as other stakeholders like HTA (health and technology assessment) agencies. As such, ensuring data quality can amplify the probability of you successfully bringing your therapy to market or licensing it to another organization.
However, it’s not easy to produce high-quality clinical data, especially if you lack the right in-house expertise. For instance, clinical relevance, source type, and statistical validity are just a few of the many factors that can affect the quality of the data generated. In addition, managing increasingly complex and vast datasets can be challenging while protecting data quality, like when using digital devices to gather real-world data.
While companies tend to deprioritize their clinical data strategy, it can be very risky. You may end up losing considerable resource investment without any gains, and organizations with a smaller portfolio may risk their viability if their assets aren’t able to acquire regulatory approval. Here’s something more concerning: the risk of having to stop an investigation into a favorable therapy that could have changed the life of many patients.
Evaluating Methods to Better Harness Clinical Trial Data
Taking all of this into consideration, planning your data strategy, including your trial design, is important when it comes to ensuring the quality of your evidence package so you can increase the possibility of successful clinical development through proper risk management. Although many companies develop data strategies for their clinical programs, this usually happens quite late in the development process at a time when a data strategy is no longer as useful.
ClinicalPURSUIT’s EDC and Dashboard Tools Can Help You Harness Clinical Trial Data Efficiently
ClinicalPURSUIT’s electronic data capture software for clinical trials can benefit device manufacturers, biotech, pharmaceutical companies, CROs (clinical research organizations), and sponsors.
Why not schedule a free demo and see how Clinical PURSUIT can transform your clinical trial experience!