Brain Injury Outcomes
The BIOS Clinical Trials Coordinating Center, led by Daniel F. Hanley, MD, is an academic research organization within Johns Hopkins School of Medicine. It specializes in providing multicenter management for clinical trials across various medical conditions, including neurology, rare diseases, ICU conditions, rehabilitation, pain management, and functional outcomes. The center is disease-agnostic with expertise in coordinating and managing trials, supporting investigators at Johns Hopkins and beyond, and developing innovative clinical trial methods. It is part of the Johns Hopkins Institute for Clinical and Translational Research and the Trial Innovation Network, with a focus on developing therapies that change lives.
Industries
Nr. of Employees
small (1-50)
Brain Injury Outcomes
Baltimore, Maryland, United States, North America
Products
Open-source vestibular decision-support algorithm
A non-proprietary, heuristic decision-support algorithm to guide emergency department triage of vestibular patients based on eye movement decision rules; intended for broad public use.
MISTIE III training modules (archived CME version)
Online training modules covering protocol operations, imaging assessment, surgical technique, dosing, safety reporting, regulatory compliance, outcomes assessment, and pharmacist responsibilities for a multicenter ICH trial.
90-Day Start-Up guideline package
A compiled set of monthly checklists, templates, and timelines designed to drive site activation and readiness for first patient enrollment within a 90-day period.
Open-source vestibular decision-support algorithm
A non-proprietary, heuristic decision-support algorithm to guide emergency department triage of vestibular patients based on eye movement decision rules; intended for broad public use.
MISTIE III training modules (archived CME version)
Online training modules covering protocol operations, imaging assessment, surgical technique, dosing, safety reporting, regulatory compliance, outcomes assessment, and pharmacist responsibilities for a multicenter ICH trial.
90-Day Start-Up guideline package
A compiled set of monthly checklists, templates, and timelines designed to drive site activation and readiness for first patient enrollment within a 90-day period.
Services
Operational management of multicenter trials including protocol implementation, site management, safety oversight, and investigator support.
Database design and management, advanced biostatistics, adaptive randomization support, and trial reporting.
Harmonization of image acquisition, quantitative volumetric analysis, image processing pipelines, and centralized reporting for multicenter studies.
Structured site activation workflow with monthly checklists to achieve IRB submission, contracts, delegation logs, training, and site initiation within 90 days.
Preparation of regulatory documentation, IND/IDE support, coordination with IRBs and acting as IRB of record for multicenter trials.
Quality assurance activities including monitoring visits, source document verification, and eTMF management to ensure protocol and regulatory compliance.
Operational management of multicenter trials including protocol implementation, site management, safety oversight, and investigator support.
Database design and management, advanced biostatistics, adaptive randomization support, and trial reporting.
Harmonization of image acquisition, quantitative volumetric analysis, image processing pipelines, and centralized reporting for multicenter studies.
Structured site activation workflow with monthly checklists to achieve IRB submission, contracts, delegation logs, training, and site initiation within 90 days.
Preparation of regulatory documentation, IND/IDE support, coordination with IRBs and acting as IRB of record for multicenter trials.
Quality assurance activities including monitoring visits, source document verification, and eTMF management to ensure protocol and regulatory compliance.
Expertise Areas
- Multicenter clinical trial management
- Clinical data management and biostatistics
- Imaging core and quantitative neuroimaging
- Trial start-up and site activation
Key Technologies
- Electronic data capture (EDC)
- Electronic trial master file (eTMF)
- Clinical trial management systems (CTMS)
- Cloud-based imaging analytics
News & Updates
The BIOS CTCC study CSSC-004 was named one of the Top 10 2023 Clinical Research Achievement Awardees by the Clinical Research Forum.
The Johns Hopkins University Division of Brain Injury Outcomes announced the 2022 recipients of the Ann Dana Kusch Predoctoral Fellowship, Paul Ryu.
A recent publication on the coordination of COVID-19 plasma trials.
A study on hydroxyurea for preventing brain injury in children with sickle cell disease.
Recognition by the Clinical Research Forum for excellence and innovation in clinical research.
The BIOS CTCC study CSSC-004 was named one of the Top 10 2023 Clinical Research Achievement Awardees by the Clinical Research Forum.
The Johns Hopkins University Division of Brain Injury Outcomes announced the 2022 recipients of the Ann Dana Kusch Predoctoral Fellowship, Paul Ryu.
A recent publication on the coordination of COVID-19 plasma trials.
A study on hydroxyurea for preventing brain injury in children with sickle cell disease.
Recognition by the Clinical Research Forum for excellence and innovation in clinical research.