Proxima CRO
Proxima Clinical Research, Inc. (Proxima CRO) is a healthcare-focused CRO that combines technology, therapeutic experience, and agile management principles to de-risk biotech and MedTech programs, increase chances of regulatory clearance, and improve capital efficiency. Headquartered in Houston, TX, it offers regulatory, clinical, and quality management services to help clients meet industry milestones and overcome hurdles.
Industries
Nr. of Employees
small (1-50)
Proxima CRO
2450 Holcombe Blvd, Houston, TX 77021
Products
Early Phase Oncology Fact Sheet (template)
A downloadable fact sheet template intended to support early‑phase oncology program planning and sponsor communications.
Early Phase Oncology Fact Sheet (template)
A downloadable fact sheet template intended to support early‑phase oncology program planning and sponsor communications.
Services
Strategy development and hands‑on support for regulatory pathways, filings and dossier preparation across device and drug pathways.
Protocol design, adaptive/flexible study design support and operational management of clinical trials using agile processes.
QMS implementation, SOP drafting, electronic QMS installation support, audit preparation, and manufacturer auditing to meet inspection and compliance requirements.
Design and execution support for post‑market studies, real‑world evidence generation, and regulatory label‑expansion strategies.
Enablement of access to EMR, laboratory, claims, remittance, chargemaster and specialty Rx data through data aggregator partnerships to support commercial and clinical decision making.
Advisory services for evaluating eligibility and preparing submissions for Breakthrough Device Designation, including articulation of program benefits and clinical design flexibility.
Strategy development and hands‑on support for regulatory pathways, filings and dossier preparation across device and drug pathways.
Protocol design, adaptive/flexible study design support and operational management of clinical trials using agile processes.
QMS implementation, SOP drafting, electronic QMS installation support, audit preparation, and manufacturer auditing to meet inspection and compliance requirements.
Design and execution support for post‑market studies, real‑world evidence generation, and regulatory label‑expansion strategies.
Enablement of access to EMR, laboratory, claims, remittance, chargemaster and specialty Rx data through data aggregator partnerships to support commercial and clinical decision making.
Advisory services for evaluating eligibility and preparing submissions for Breakthrough Device Designation, including articulation of program benefits and clinical design flexibility.
Expertise Areas
- Clinical trial management
- Regulatory strategy and submissions
- Quality management systems (QMS) and audit readiness
- Real‑world evidence (RWE) and post‑market studies
Key Technologies
- Electronic quality management systems (eQMS)
- EMR/EHR data integration
- Claims and billing data aggregation
- Real‑world evidence (RWE) analytics