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.
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.
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.
Areas of Expertise
Your agile CRO partner in
the following BioTech therapeutic areas
FREQUENTLY ASKED QUESTIONS
Will FDA need access to case records maintained by the investigator or additional background data such as hospital or other institutional records?
Learn MoreGlossary
Form FDA 1571
Learn MoreLatest INsight
Biotech and MedTech Funding Series: Funding an Oncology Startup with CPRIT
Learn MoreLatest Video
The Relationship Between Clinical Trials and Regulatory Affairs
Learn MoreLooking to bring your next Biotech product to market?
Proxima's team of experts would love to work with you.
Speak with a biotech expert