Discover How
Site Startup
Patient Enrollment
Data Management
Monitoring
Can Change with Proxima
Proxima CRO takes a Full-Service approaches to complex clinical development goals. We tailor fit for purpose solutions to ensure the successful execution of your trial
Our Core Focus Areas:
Clinical Services For Medical Devices, Drugs, & Diagnostics
Clinical Monitoring
Clinical Data Management
Clinical Trial Biostatistics
Safety Management & Medical Monitoring Services
Site Startup & Success
US Clinical Trial Document Management (TMF & ISF)
US Clinical Trial Project Management
Experience with over 200+ sites
In the last five years, Proxima has worked with over 200 sites in North America
Our select partners give us true global reach.
Drug and Device experience in over 30+ therapeutic areas
Relationships with the best clinical sites in the world
Therapeutically aligned site networks
A commitment to communication & training, ensuring fewer deviations
Time to SIV
Proxima
7 Weeks
Industry
4 Months
Time to FPI post SIV
Proxima
3 Weeks
Industry
7 Weeks
Data Management
We do not outsource data management. Period.
Our in-house team allows better communication with the study team, shortens dB builds by 50%, and yields to industry leading SIV times.
Our comprehensive data management solutions include:
Electronic CRF design
Thorough manual and programmatic review of data
eConsent and DCP
Adverse event and medication coding
eDC selection, build, validation, and training
Database lock
Data transfer
Integration with Best-in-Class Technology
We created an ecosystem through partnerships with best-in-class technology providers
to ensure that your data is safe, and that cost-savings are passed on to you.
Let us build your custom toolset
Statistics
Leadership from a team that has contributed significantly
to the success of multiple marketing applications.
Services Include:
Study design & sample size determination
Development of statistical analysis plans
Randomization schedules
Programming of tables, listings & figures
Preparation of integrated summaries
Data integration & data conversion
Filing and reporting with regulatory bodies
Statistical analysis reports
"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."
Position
First & Last Name
"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."
Position
First & Last Name
Our Experts
Meet
Carolina Marchena
Our
Senior Clinical Trials Assistant
HOMETOWN:
Mendoza, Argentina
Most of my free time I spend with my children, but when I have some time alone, I love anything that involves exercising, cooking or crafting
OUR PROCESS
Through our intelligence platform and solutions, our team of therapeutic and operational experts can support all aspects of your cardiovascular clinical and commercial operations, allowing for easier innovation and earlier access to market.
Frequently Asked Question
The FDA regulations exempt an emergency use of a test article from prospective IRB review, however, "... any subsequent use of the test article at the institution is subject to IRB review." What does the phrase "subsequent use" mean?
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