Ensuring High-Quality, Reliable Clinical Data
Data ManagementManaging clinical data effectively is crucial for successful trial outcomes. Our dedicated team provides end-to-end support to ensure accuracy, consistency, and compliance.
Optimized for accurate and efficient data collection.
Tailored solutions to fit study requirements.
Ensuring data integrity and compliance.
Proactive oversight to maintain data integrity, transparency and compliance with ICH GCP.
Ensuring consistency in clinical data reporting.
Terms standardization for consistent data analysis and reporting.
Providing actionable insights for better decision-making using BioGRID Bioforum’s analytics and visualization tool.
Choosing the right data capture technology is critical for study success. Bioforum partners with leading technology vendors to offer flexible and robust solutions, ensuring smooth data collection and management.
Ensuring the quality and integrity of your clinical data and biostatistical outputs is critical to achieving reliable outcomes. Our expert consultancy services provide the oversight you need to optimize your trial’s data management and biostatistical processes, reduce risk, and accelerate timelines.
Our expert team actively contributes to thought leadership and decision-making within leading industry organizations, ensuring that our practices align with the latest ICH guidelines. Through continuous engagement, we help shape industry standards while maintaining full compliance with ICH requirements across every stage of clinical development.
Aligning data capture tools with clinical objectives.
Ensuring consistency and accuracy in coding practices.
Embedded quality into study design from the start and tailored services based on trial complexity and risk.
Supporting informed decision-making at every stage.
Although ICH Q9 already directed our focus to risk-based quality management of our trials, the release of ICH E8 on Oct 21st, 2021 ushered in a new era in how we should be thinking about our clinical trial data. These regulations clearly describe how the regulatory authorities are expecting “Critical to Quality Factors” to be documented and managed. They emphasize the fact that this should be done at study start, and that study data have quality factors that should be considered at study design and proactively managed during the trial. Additionally, the internationally recognized data standards are significant as they support data reliability. This is important since data reliability helps facilitate correct analysis and interpretation of results. Lastly, the regulators make it clear that data management is a critical/key contributor to overall study data quality. It is also important that data management is part of the risk management and decision-making processes. As part of their role in the clincial study process, the data management team must identify the “critical to quality factors” that come from the way study data are collected, managed and reviewed. With new regulations having specific requirements, you can expect to be asked for evidence of all of the above at your next regulatory inspection.
Choosing the right EDC platform starts by asking the right questions. It’s important to begin by asking which functionality is necessary. This may seem obvious, but this critical step often gets missed. It’s very easy to be lured in by the bells and whistles many systems offer, but do they address your company’s needs for specific studies? Identify these needs and then analyze and prioritize them. Doing so will help you narrow down and simplify the criteria on which to base your decision and how to potentially adjust your budget. The next subject to tackle is whether the EDC integrates with other systems in your technology portfolio and how the EDC vendor’s pricing fits in with your budget. Of course, even having the right questions lined up sometimes doesn’t help when talking to various vendors. With strong sales pitches and overwhelming technical explanations, it is easy to get lost in all the information… Read the blog HERE to help you put together a robust plan to help you through the weeds in making this decision.
From the various regulatory releases over the last 5 years, it is clear that authorities are supportive of taking risk-based approaches to clinical trial management. This applies to data management and provides a different approach to data cleaning than the traditional blanket cleaning (clean as much as possible as thoroughly as possible) as well. They are telling us through their recent releases that they are not expecting all data to be clean but are rather simply expecting “the absence of errors that matter”. This confirms that notion that not all data should be cleaned equally…but where is the line… Read our blog here to help guide you through this decision.
