How can we help?
You need an imaging strategy designed for your trial: one size doesn't fit all.
We'll add value to your trial
"So you've done 20 breast cancer trials? What have you learned that will help my trial?" This guides us in providing individualized solutions. We will tell you how our experience specifically adds value to your trial.
How to decide?
Site or central reads, or both? We take site reads seriously. Our imaging strategies include both site and central read paradigms, harmonizing between them, and mitigating risks associated with both.
Did you know?
It's important to balance current regulatory recommendations and scientific advancements to ensure compliance. We do much more than RECIST with your standard of care images.
Diagnostic Imaging Drug Development Expertise
From lab to market
We provide full-service Imaging Diagnostics Clinical Development, from pre-clinical to IND and NDA submission and Medical Affairs.
Literature-Based Approvals
Utilizing only existing literature reviews, we have gained 5 new indications for imaging drugs without performing additional clinical trials.
We have developed current market leaders
We have led 7 imaging new drug approvals globally: MRI, CT, and radiopharmaceuticals.
Over 40 Years of Experience
Between our two RadMD principals, there are over 40 years of contrast agent development experience.
Customized
Imaging Endpoints
We see it all
We take into account drug MOA, patient population, disease characteristics, and prior imaging experience when recommending optimal endpoints and assessments.
RADMD Criteria Generator
We utilize our Criteria Generator in early phases to compare multiple imaging characteristics to create an assessment criteria that best captures drug response.
Reduce discordance
We harmonize site and central image assessments, and identify and train site reviewers to reduce site/central discordance.
Modifying your criteria
Criteria modification is not prohibited by regulators. Thoughtful modifications enhance signal detection, reduce noise in assessments.
We have gained 5 new indications for imaging drugs without performing additional trials.
Total Imaging
Management
Relationships Are Key
You benefit from our longstanding and productive relationships with CROs and other imaging vendors.
Site Management
We handle all imaging issues at sites, including site reads: from qualification, to technical and reader training, to site eCRF design, and site/central read congruence management.
Imaging Platform Selection
Our extensive knowledge and hands-on experience with nearly all available imaging platforms will benefit you in determining the ideal imaging tools for your clinical trial needs.
Image Analysis & Read Reports
Beyond SAS data sets, we provide expert complete reports on your imaging results, ready for submission.
Independent Reads
and Advanced Image Analysis
Readers are the most important
Readers are the most important part of the independent image review. Period. Our primary focus has been on building, training, and managing the premier industry reader group.
We only source the best experts
Our analysis experts are: board certified and subspeciality fellowship trained with at least 5 years of clinical experience; trained in GCP and multiple imaging assessment criteria via BRITI; and they're demonstrated experts in the disease process of your trial.
Wide variety of experts
Our team includes: radiologists, nuclear physicians, oncologists, cardiologists, gastroenterologists, pathologists, endocrinologists, dermatologists, and many others.
clinically-practicing experts
We require clinically-practicing experts to ensure they bring current clinical image interpretation standards to your trial. We don't accept "generalists" or clinical "trialists."
Quick and Efficient management
Our central management of readers ensures their availability to timely complete reads and our standardized qualifying, contracting, training, perfomance management, and logistics reduces clinical teams' workload.
Transparent Compensation
Our transparent and streamlined compensation process ensures sponsors that readers are fairly compensated.
We have 12 years of experience in comprehensive sourcing and management of our readers for over 600 trials.
BRITI Web Portal:
Trial Training
Our Blinded Reader and Investigator Training Institute is the first and global leader in education and training on medical imaging in clinical trials.
Training for a variety of users
We provide training for blinded readers, imaging site investigators, clinicians, CRA's, project managers and many others involved in image evaluation for clinical trials.
We provide credit
We can provide CME credit for study-specific trainings we develop, which can increase training compliance and ensures an unbiased training process.
Pre-Testing
Our pre-testing process evaluates the qualifications of the trainee, which can be built into the module.
Post-Module Testing
All modules have a post-module test with questions randomly taken from a question bank on that topic and a training certificate is created for the trial master file (TMF).
Trainings
Trainings include access to an online document library and 24 hour message board answered by RadMD experts.
Surpass current requirements
Our well-documented and standardized training meets and surpasses current regulatory requirements and any training and testing may be implemented via this flexible platform.
Guaranteed Accuracy
All of our BRITI education modules are physician expert-authored and peer reviewed, which 100% guarantee accuracy.
Post-Testing
Our post-testing process confirms the user is competant to perform the tasks they were trained in.
Library vs. Study Specific
You can select from our BRITI training library, which consists of standard modules for various criteria or we can create your study-specific trainings in a matter of weeks.
Let BRITI benefit you
Any training type can be implemented on BRITI, benefitting all trial personnel from CRA's and study managers to data managers and biostatisticians.
Unique Regulatory
Expertise
40 years combined
Before RadMD, our principals led Clinical Development groups at a global pharmaceutical company.
Experience Beyond Audits
We actively participate in FDA/EMA and others’ Advisory Board meetings. We've contributed to FDA and EMA Guidelines on Imaging. Our unique expertise, applied to your trial, will minimize the regulatory uncertainties of imaging.