Proxima CRO
Proxima CRO is a leading Contract Research Organization (CRO) that specializes in providing innovative solutions for medical devices, drugs, and diagnostics. With a focus on agility and efficiency, Proxima aims to de-risk biotech and MedTech programs, enhance regulatory clearance chances, and optimize capital efficiency. The company is dedicated to supporting clients through every stage of clinical development, ensuring timely and cost-effective results.
Industries
Nr. of Employees
small (1-50)
Proxima CRO
2450 Holcombe Blvd, Houston, TX 77021
Products
Regulatory CRO Services
Support from development to launch, including planning and coordinating US/European Medical Device or Drug submissions, agency representation, and human factors and usability testing.
Clinical CRO Services
Assistance with clinical trials, including First in Human Studies, Accelerated POC, Early Phase/Phase 1, Trial Design & Management, and Confirmatory Phase IIB – Phase III Studies.
Quality Management (QMS) CRO Services
Support for building and maintaining Quality Management Systems, including verification and validation, advisory consulting, and oversight of activities.
Data Management
In-house data management solutions including electronic CRF design, data review, eConsent, adverse event coding, eDC selection, database lock, and data transfer.
Statistics
Services include study design, sample size determination, development of statistical analysis plans, randomization schedules, programming of tables, and preparation of integrated summaries.
Regulatory CRO Services
Support from development to launch, including planning and coordinating US/European Medical Device or Drug submissions, agency representation, and human factors and usability testing.
Clinical CRO Services
Assistance with clinical trials, including First in Human Studies, Accelerated POC, Early Phase/Phase 1, Trial Design & Management, and Confirmatory Phase IIB – Phase III Studies.
Quality Management (QMS) CRO Services
Support for building and maintaining Quality Management Systems, including verification and validation, advisory consulting, and oversight of activities.
Data Management
In-house data management solutions including electronic CRF design, data review, eConsent, adverse event coding, eDC selection, database lock, and data transfer.
Statistics
Services include study design, sample size determination, development of statistical analysis plans, randomization schedules, programming of tables, and preparation of integrated summaries.
Expertise Areas
- Clinical trial management
- Regulatory strategy and global submissions
- QMS implementation and audit readiness
- Human factors and usability evaluation
Key Technologies
- Electronic data capture (eDC)
- Electronic CRF (eCRF) design
- eConsent systems
- Electronic quality management systems (eQMS)
Key People
News & Updates
Proxima's involvement in a consortium aimed at advancing pediatric medical device development.
Next Oncology collaborates with Proxima to enhance cancer therapy development.
A proposal by CMS to expedite Medicare access to innovative medical devices.
Proxima was recognized for its outstanding performance and contributions to the healthcare industry.
Best Places to Work
Proxima was recognized as one of the Best Places to Work by Modern Healthcare.
Inc. Best in Business 2022
Proxima was awarded the Inc. Best in Business award for its contributions to the healthcare industry.
Proxima's involvement in a consortium aimed at advancing pediatric medical device development.
Next Oncology collaborates with Proxima to enhance cancer therapy development.
A proposal by CMS to expedite Medicare access to innovative medical devices.
Proxima was recognized for its outstanding performance and contributions to the healthcare industry.
Best Places to Work
Proxima was recognized as one of the Best Places to Work by Modern Healthcare.
Inc. Best in Business 2022
Proxima was awarded the Inc. Best in Business award for its contributions to the healthcare industry.