INDUSTRY: bioTech

The Future of Drug Discovery

New science calls for new solutions.
Learn about Proxima's agile life science solutions.
IND to NDA
…and everything inbetween

Our personalized biotech approach

Your products are built with scientific intricacy.
Our experts understand.
Get your site up-and-running efficiently with a CRO partner that understands the complexities of biotechnology and pharmaceuticals.

Proxima combines IND, NDA, & CMC with Evidence Gathering, Data Insights, and Launch Preparation to build a custom solution that matches your unique requirements. Our end-to-end biotech solutions focus on agility and accountability to ensure your product reaches launch.

gUIDING YOU THROUGH Clinical Development

There’s a lot riding on your program and the odds are against you. Work with a partner that can help you derisk your strategy and get you from IND to NDA faster and preserving capital.
Clinical Trial Phases with Capitalized Cost and Probability of Attrition
Regulatory strategy
Medical and scientific driven strategies led by world class experts.
Submission support
IND, 505b(1), 505b(2), ANDA, BLA
Clinical Evidence
Full Service Ph 1 – 3, FSP, Medical Monitoring
Post-market
HeOR and RWE. Access to large scale hospital data sets (EMR, Chargemaster, Claims, Remits, Rx, Lab, Infusion, Social Determinants of Health).

Client-focused CRO

Your product was created by agile teams with a vision, a propensity for action, and a winning culture.
Trust your clinical trial with a CRO that shares your values.
"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 has been an important piece of Memgen's regulatory and clinical achievements for multiple years now, playing a vital role in our IND approval, clinical launch, and trial management of our first-in-human study of our lead cancer immunotherapy biologic. Proxima and its growing team have continually shown their experience, broad skill sets, adaptability to our company's needs and objectives, and value in an industry with a myriad of CROs to choose from.
CSO
Mark Cantwell

FREQUENTLY ASKED QUESTIONS

What steps will FDA take before imposing a clinical hold to protect subjects from investigator misconduct?
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Glossary

Form FDA 1571
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Latest INsight

Proxima Clinical Research Launches Early Phase Oncology Network for New Investigational Therapies
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Latest Video

Can You Use Your Manufacturer's QMS?
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Looking to bring your next Biotech product to market?
Proxima's team of experts would love to work with you.
Speak with a biotech expert