Central Nervous System » Imaging » Clinical Trial Services

Centralized image collection and management for clinical trials is a complex and time consuming process. Our workflow uses a process paradigm and validated technologies designed specifically for imaging in clinical trials. We perform all imaging core lab services with the regulatory rigor required for your imaging data.

Protocol Development
Leverage Biomedical System’s expertise for Regulatory consultation. We can help you create required study documentation, including the Study Protocol, Statistical Analysis Plan, Independent Review Charter, CRF’s, Data Management Plan, Common Technical Documents, and Integrated Summary of Efficacy.

Pre-Study Planning
Every clinical trial is unique. We can assist you to ensure protocol compliance by developing integrated imaging instructions in the Independent Review Charter, Imaging Lab Charter, Site Manual, and related Study Forms.

Reader Selection & Preparation
Our unique reader model matches global experts from sponsors, leading research centers, and clinical practices to your protocol objectives. This maximizes the accuracy and validity of your clinical and medical data.

Clinical Site Initiation
From ACR accreditation, to phantoms, to training, we prepare your sites to adhere to your protocol and to produce high quality source data.

Image Data Collection
Working with sites in over 70 countries, we will track, convert to DICOM, and centralize your imaging studies in our BGSMedsource™ digital database.

QA/QC Processes
Following detailed SOP’s, we will assess, resolve queries, blind, and randomize all study images.

Data Processing
Using advanced methods to collect clean data and back-end processes to assure usable data, we provide our sponsors with timely access to imaging data in the formats they require.

Expert Physician Review
Our selected readers are Board certified and sub-specialty trained experts. Working from our labs in St. Louis or Brussels, or virtually any location, they develop accurate and valid data in support of your study objectives and endpoints.

Regulatory Submission
We will prepare a final study report documenting the conduct of the imaging portion of your clinical trial and provide a comprehensive database to include with your regulatory filing.

Quality Assurance and Regulatory Affairs

Obtaining high quality imaging data is essential to determining patient safety and clinical efficacy. Our QA and RA groups prospectively define comprehensive quality procedures and methods according to GCP and CFR 21 Part 11 guidelines, ensuring complete documentation for FDA / EMEA audits. Ongoing monitoring of active studies ensures compliance to these standards.

Data Management

Clean and accurate data acquisition begins with our 4^th generation BGSMedsource™ database and LifeRx™ assessment software. Working closely with your data management group, we can perform a data analysis or deliver the data in the format and frequency you need for interim and final data analysis.

Consultation

Whether your need is protocol design, medical writing, statistical planning and analysis and more, Biomedical Systems can provide ad hoc support for virtually any gap in your imaging resources.