Oversight of your clinical program, specifically the data, is key to a positive study and ultimately a successful regulatory filing. Most clinical trial failures are preventable. BIA has proven expertise to proactively mitigate potential data quality issues by providing excellent oversight throughout the entire project.

We can provide experienced resources to augment your team, functioning as a virtual project team to ensure your programs stay on track and eliminating last-minute surprises.

BIA has extensive experience in the remediation of data quality issues within study databases. We determine exactly where the raw data issues are, and then write and resolve queries.

In terms of statistical programming, regardless of your study has known problems or if you want to proactively check the quality, BIA can pinpoint where the issues are with your SDTM and ADaM datasets and output deliverables, and then work with your CRO to get them resolved. BIA will give you peace-of-mind that there won’t be any data-related or statistical programming-related issues that can derail your end-game activities.

Clinical Strategy from pre-IND through submission is critical to program success. Many studies and ultimately programs fail due to suboptimal efficacy endpoints, flawed study designs, inappropriate data collection and analysis, and problems with study operations. BIA can help you strategize before your project begins, to ensure that you are set up for success and the best possible outcome.

The quality and completeness of your study’s Trial Master File (TMF) is critical to your company being inspection ready at all times. Has your TMF been contemporaneously maintained throughout the lifecycle of your study? If not, you should be concerned. BIA has extensive experience reviewing TMFs, identifying potential gaps and solutions to help get TMFs back on track.