Clinical Adjudication Solution
Advancing the clinical trial process so you can focus on the outcomes.
Event adjudication plays a crucial role in the clinical trial journey for developing life-improving therapies. Partnering with Bioclinica to manage your clinical adjudication program means you will have a dedicated project management team and access to our global network of clinical experts to support your trial anywhere in the world. At the core is our comprehensive, web-based platform that ensures the accuracy, transparency, and compliance you need every step of the way.
Your trusted partner for a comprehensive Clinical Event Committee solution
Partners you can trust to manage your program
Collaborative project plans are critical success factors in effectively meeting timelines and deliverables. Our team of program and project managers has over 100 years of cumulative experience in clinical adjudication. We partner with you from day one and support your program through the end of study.
- Initiate rapid launch of new studies or transition of existing data with rescue studies
- Engage professional project managers, nurses, and medical writers to ensure your study is consistent with charter requirements
- Coordination of Clinical Event Committee (CEC) meetings are fully managed by the project management team
- Facilitate global trials at the country level with dedicated project managers, localized language support, and translated user interface and training materials—no on-premise servers required
Deep clinical domain expertise when it matters most
Our vast global network of medical experts specializes in specific endpoint therapeutic areas, including (but not limited to) pulmonology, cardiovascular, gastroenterology, MSK, and neuroscience.
- Draw from Bioclinica’s 30 years of medical expertise and extensive network of key opinion leaders across nearly all therapeutic areas
- Expert guidance on charter design by our veteran adjudication specialists and clinicians
- Gather insights throughout your trial with full data transparency that displays research site, user, and adjudicator performance metrics visually
Enhance your data quality with our comprehensive web-based platform
A centralized online repository of source documents, DICOM, videos, photos, and ECGs, simplifies the management of the adjudication process.
- Achieve 100% de-identification of all of source documents, images, videos, and photos with our AI technology, as well as quality control (QC) and query management for all source document types for patient privacy
- Enforce compliance with 21 CFR Part 11 and EU GDPR requirements
- Reduce manual errors and costs with automatic routing and de-identification
- Integrate easily with 3rd-party applications including Electronic Data Capture (EDC) and safety systems
- Address questions quickly with access to live support 24/7/365 via chat, phone, or email within the platform
Discern COVID-19-related adverse events from your pulmonary endpoints
COVID-19 adds significant risk for pharmaceutical and medical device clinical trials by confounding important safety endpoints. Bioclinica’s COVID-19 Clinical Adjudication Solution is a comprehensive CEC offering. Our experienced program management team and clinical experts can partner with you to determine if an endpoint adjudication process should be considered to discern
COVID-19 adverse events from those unrelated to the novel coronavirus.
