CLINICAL SOLUTIONS

Management, data, monitoring, and statistics

At Proxima, we know that you’ve put all your blood, sweat, and tears into your company. We get that you don’t have time for the traditionally slow timelines and clunky processes that often accompany large CROs.

We’re taking the experience and solutions found in those larger companies and fine-tuning them to meet the needs (and timelines) of your emerging company. Our clinical trial solutions are tailored for you, instead of the other way around.

If you have an entrepreneurial spirit, why shouldn’t your CRO be the same? Let Proxima take the selection process stress off your shoulders, so you can focus on what you do best.

project management

We utilize agile project management.

We utilize a project management style that incorporates agile project methodology, originally developed for the software industry, resulting in a process that is efficient and painless.

Agile Project Management allows for responding to issues quickly. As the project progresses, velocity increases. An agile framework allows changes to be made quickly, which saves resources and accelerates delivery at a lower cost.

We also provide:

Therapeutically-aligned, experienced staff
Study logistics
Customized reporting
Vendor management
Risk mitigation and contingency planning
Training

Clinical Monitoring

We provide multiple options that maximize quality, emphasize speed, and prioritize customer service.

Excellent service stems from truly understanding the customer's expectations and putting the right plan in place to exceed them. Our clinical research associates (CRAs) are of the highest caliber with therapeutic experience in the most active areas of biotech and clinical research.

When an organizational framework properly unites its people, places, and processes by putting the customer at its core, exceptional service becomes possible across customer touch points. Proxima's employees at the front line are empowered to perform.

Our CRAs have:

Broad therapeutic and medical device experience
Long-lasting relationships with the best clinical sites in the world
A commitment to communication and training that ensures fewer deviations and queries

DATA MANAGEMENT

Our focus is on delivering accurate & clean data quickly.

Our comprehensive data management solutions include:

Paper or electronic CRF design
Data entry for paper based CRF
eDC selection, build, validation, and training
Thorough manual and programmatic review of data
Adverse event and medication coding
Database lock
Data transfer

The eDC systems we work with include:

ClinCapture
Medrio
iMedNet
Oracle InForm
Medidata
Bioclinica

STATISTICS

Our team has contributed to a significant number of successful marketing applications.

Statistical Services Include:

Study design and sample size determination
Development of statistical analysis plans
Randomization schedules
Programming of tables, listings and figures
Preparation of integrated summaries
Data integration and data conversion
Filing and reporting with regulatory bodies
Statistical analysis reports