Service: Clinical

Discover How

Site Startup

Patient Enrollment

Data Management

Monitoring

Can Change with Agile Clinical

Connecting People, Process and Technology
Over 90% of life science products fail in clinical trials!
Improve the odds of success.
Agile isn’t just for software development.
Most clinical trials are not
completed on time.

They are often over budget, fail to meet their enrollment and/or endpoints. Often these problems are a product of poor management and reactive teams.
Agile breaks tasks into smaller increments delivering value with each cycle.

Communication is increased. Budgets are preserved. Deadlines are kept. Expectations are met.

ASPIRATIONAL INSPIRATIONAL CLINICAL RESULTS

Through a combination of curated clinical sites, technology, and agile processes
we are setting a new standard for CROs
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Time to SIV

Proxima

7 Weeks

Industry

4 Months

Time to FPI post SIV

Proxima

3 Weeks

Industry

7 Weeks

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
"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
"Proxima has been attentive to a variety of our regulatory related needs. From coordinating studies with aggressive timelines to assisting with sales aid approvals, they have always delivered. As we launched our first in class/disease product, we needed a high touch clinical research and regulatory partner, and Proxima has provided that for us."
Founder & CEO
Robert Whitehead
"Proxima staff understood the needs of our company and took a vested interest in supporting our clinical trial’s aggressive timeline while safeguarding our goals and objectives. Proxima has been a true partner for our early stage medical device startup!"
Sr. VP, Marketing & Clinical Development
Zaffer Syed

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
Talk to a clinical expert

Our Experts

Meet
Jerika Acosta
Our
Director of Clinical Operations
HOMETOWN:
North Palm Beach, Florida
Jerika loves fast cars
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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 leads to leads 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

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

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

Does FDA prohibit direct communication between sponsors and IRBs?
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Glossary

Serious Adverse Event (SAE)
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Latest INsight

FDA Issues Final Guidance: Device Software Functions and Premarket Submissions
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Latest Video

Can You Use Your Manufacturer's QMS?
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Need an extra hand for your clinical trial?
We're ready to help.
Speak with a Clinical expert