Clinical Data Management Services

Navigate your trial's complexities with smart data management

Our clinical data management team upholds the highest standards of data integrity and FDA compliance for your medtech and biotech clinical trials.

We meticulously handle every aspect of data collection, validation, and management, ensuring accurate and reliable results throughout your clinical study.

Engage

Our team collaborates closely with you to provide intelligent data management solutions that enhance the quality and success of your clinical trial.

[Metric idea: # EDC studies completed, % Reduction in resource costs]

Our Approach Data Management Services

Precision Data Management

Our data management team develops efficient, secure, and compliant specifications for clinical trial data collection, organization, validation, and analysis.

With your end goal in mind, our approach works backwards along the regulatory pathway to ensure all data is reported, displayed, and captured in full compliance with global data and reporting requirements.
‍
Focusing on precision and efficiency, while maintaining the highest standards of data quality and integrity, our experts prioritize communication and accountability to keep your trial on track and within budget.

Experienced TEAM

Our data managers are skilled professionals with extensive experience in managing clinical trial data across various therapeutic areas.

Comprehensive Support

We offer end-to-end data management services, ensuring all your data needs are met efficiently and effectively.

Commitment to Quality

Our rigorous processes and attention to detail ensure the highest standards of data quality and compliance with regulatory requirements.

Customized Solutions

We tailor our data management plans to fit the unique needs of your study, ensuring optimal data collection, management, and reporting.

Clincial Trial Services

Our Data Management Services

Clinical Data Management Plan (CDMP) Development

Data Management Plan:
Creation of a detailed plan outlining the processes and procedures for managing study data, ensuring consistency and compliance throughout your clinical trial.

Data Review Plan:
Development of a plan to systematically review data for accuracy and completeness, including timelines and responsibilities of each clinical team member.

Case Report Forms (CRFs) and Database Specifications

Case Report Forms (CRFs):
Development of eCRFs based on protocol requirements in collaboration with your team, ensuring all necessary data points are captured.

Database Specifications:
Detailed documentation of the database build, including all fields, edit checks, and data entry guidelines

Electronic Data Capture (EDC) Setup

EDC Build:
Configuration of EDC system, including the creation of groups, visits, and forms in accordance with study-specific CRFs and protocols.

User Acceptance Testing (UAT):
Conducting thorough UAT to ensure the EDC system meets all study requirements before going live.

Data Review and Query Management

Data Review:
Our data managers execute an ongoing review of your clinical data, working closely alongside CRAs, to ensure accuracy and completeness of the data collected.

Query Management:
Identifying, creating, and resolving data queries to ensure clean data for analysis.

Medical Coding

Coding of Data:
Assigning numerical values to drugs or diagnoses using standardized coding libraries such as MedDRA and WhoDRUG to ensure consistency and accuracy.

Database Maintenance and Updates

Database Updates:
Implementing necessary updates to the database driven by external requirements or protocol amendments, ensuring minimal disruption to your clinical study.

Closeout Phase

Database Lock:
Ensuring all queries are resolved, terms are coded, and all data is reviewed and finalized before database lock. Providing final casebook downloads to sites and ensuring readiness for regulatory inspections.

"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

"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 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

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

Junior Project Engineer

Karen Wells

“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.

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

"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

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

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.

Physician

Chester J. Koh, MD

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.