Seamless management of your clinical data from the industry experts
Capturing high-quality clinical trial data is essential for safeguarding patient safety and validating efficacy in clinical development. Phastar offers a comprehensive range of data management services across the clinical trial spectrum, from Phase I to Phase IV. Our experts possess a profound understanding of database design, process, cleaning and delivery. We’ll collaborate seamlessly with your team, passionately helping you meet stringent quality standards in the generation and management of your clinical trial data.
Database architecture
Third party data integration
Data entry accuracy
Validation processes
Discrepancy strategies
Medical coding proficiency
Data extraction methods
Database locking
Effective data management is critical to the success of your clinical trial. Our team of specialist data professionals can act as the central hub for your data management, collecting, cleaning and interrogating your data to ensure it is of the highest quality. We adhere strictly to ALCOA+ principles, creating data sets that are attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available.
You can rely on us for your data management. We’ll liaise with all the relevant stakeholders to collate all the data into one place. We’ll manage your data, comparing data sets to ensure consistency throughout the study, including those from specialist vendors, such as laboratories and wearable devices. And you’ll have full oversight, with regular status updates and reporting, helping you meet GCP compliance. Giving you the confidence your data is always in safe hands.
Automated systems for flagging abnormal or missing data means you’re always protected. We’ll use human intervention wisely, working across multiple data sets to check discrepancies and correct them. Approaches are scalable to your study size and needs, whether you’re including ten participants or ten thousand.
We offer a number of models to help create bespoke packages to your needs. You can bring one of our world-leading experts directly into your team to oversee your full program, including vendor oversight, or work with our project team to handle everything on your behalf. And we can support from the very start of your project, helping you plan input and review cycles to accelerate your trial development.
Every step in our data management process operates through our Phastar Discipline, a set of proprietary rules that guarantee an error-free approach. With a unique three-stage quality check, utilizing independent senior professionals, you can be sure that your data is managed for at the highest standards.
Flexibility is at the core of our service. We utilize our own Clinical Intelligence tools for data management, alongside Medidata and Medrio for electronic data capture (EDC), allowing us to support you with additional data requirements, including medical coding, local laboratory management, risk-based monitoring, electronic clinical outcome assessment (eCOA) and interactive web randomisation systems (IWRS).
We can also integrate and work within your own systems. We have experience across a range of systems, alongside the knowledge and skills to quickly grasp any that may be less familiar. If you don’t have your own system, but have a specific preference, we are happy to explore implementation for long-term projects, taking the full burden off your team.
“We recognize the substantial effort that was needed in a short amount of time. You rallied, focused, and dedicated 150% of yourselves so we could get these responses into the Agency as quickly as possible.”
Pharma client