Clinical Trial BIostatistics Services

Transform Complex Data Into Actionable Insights for Your Clinical Trials

Our team of biostatisticians use advanced statistical methods to analyze trial data, ensuring robust and reliable results that drive your research forward.

Engage

Partner with us to leverage our statistical expertise and achieve meaningful outcomes for your clinical trials.

[Metric Ideas: #Clinical trials, #Adaptive design trials, #Independent DMC]

Our Approach Biostatistics Services

Data-Driven Decisions by experts

Our biostatisticians create custom-designed programs based on extensive experience and knowledge to optimize your trial outcomes.

We capture, analyze, and present trial data, providing you with evidence to support a successful clinical trial. Our comprehensive program includes trial design consultation, cutting-edge statistical methodology recommendations, advanced programming capabilities, and meticulous reporting.

Using industry-standard software, we deliver efficient, high-quality data analysis to empower your research with precision and insight.

Experienced Biostatisticians

Our team consists of seasoned biostatisticians with extensive experience in analyzing clinical trial data across various therapeutic areas.

Advanced Methodologies

We employ the latest statistical techniques and software to ensure accurate and insightful data analysis.

Regulatory Expertise

Our biostatistical services are designed to meet all regulatory requirements, ensuring your data analysis supports successful trial outcomes and compliance.

Customized Approach

We tailor our statistical analysis plans to fit the specific needs of your study, providing you with the most relevant insights and support. Our Services

Clincial Trial Services

Our Clinical Trial Biostatistics Services

Statistical Analysis Plan (SAP) Development

Customized SAP:
Creation of a detailed statistical analysis plan outlining the methodologies and techniques to be used, ensuring alignment with study objectives and regulatory requirements.

Analysis Framework:
Establishment of the framework for analyzing data, including statistical tests and data handling procedures.

Data Analysis and Interpretation

Descriptive Statistics:
Summary and interpretation of study data, including means, medians, and standard deviations, to provide a clear understanding of trial results.

Inferential Statistics:
Application of advanced statistical methods to test hypotheses and determine the significance of study findings.

Statistical Reporting

Comprehensive Reports:
Preparation of detailed statistical reports that clearly present analysis results and interpretations, supporting regulatory submissions and publication.

Data Visualization:
Creation of visual representations of data, including graphs and charts, to enhance understanding and communication of results.

Regulatory Submission Support

Submission Documentation:
Preparation of statistical sections for regulatory submissions, ensuring compliance with FDA and other regulatory body requirements.

Audit Preparation:
Ensuring all statistical documentation is complete and ready for regulatory inspections and audits.

"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

Position

First & Last Name

Proxima was instrumental to our success in getting breakthrough device designation for our product! The team was very knowledgeable and responsive and set us up for success. They made the FDA process easy to go through and prepared us for future interactions with FDA.

Co-Founder

Jade Doucet-Martineau

We have had the pleasure of working with the Proxima team for over a year on overall regulatory strategy and support for FDA interactions. The entire Proxima team are unbelievably knowledgeable in this space with excellent communication skills, highly strategic thinking, and amazing customer service. We at Prenosis highly recommend them as a one stop shop for anything regulatory or clinical trial related, all offered at a very attractive price point.

CEO and Co-Founder

Bobby Reddy Jr.

“Proxima has been such a wonderful help every step of the way. Everyone is truly great to work with.”

Junior Project Engineer

Karen Wells

"The wonderful people at Proxima have been dogged champions for our success. Aside from being deeply experienced in our particular field and keenly knowledgeable on developing trends they take our success as personally as we do. That, as much as anything, has been the difference."

COO & Co-Founder

Geoffrey Lucks

"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

“As a busy surgeon developing a Class III implantable device I needed help with regulatory strategy and execution. I wanted someone that was as passionate about the device as I was and that could hit the ground running. Because PROXIMA supports emerging companies through Med Tech Innovator they were a perfect fit. Isabella also helped us manage other vendor relationships and kept things moving forward. I been very happy working with PROXIMA”

Founder

Marc Bessler, M.D.

We joined forces with Proxima's Quality Consultants to ready ourselves for upcoming audits of both our QMS and our parent company's QMS. Their approachable, expert team delivered essential support and insightful guidance, never shying away from directing us confidently towards the right path. We are proud to share our spotless ISO 13485 recertification audit, a testament to Proxima's steadfast commitment and fearless leadership!

Regulatory & QA Manager

Michael Selva

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

Developing medical technology for children has unique challenges. The Southwest National Pediatric Device Innovation Consortium (SWPDC) is a consortium supported by an FDA grant to assist innovators with their pediatric device development as well as address their regulatory challenges. Proxima has been a strong partner for us in helping guide innovators quickly through their regulatory and clinical journey.