Safety Management & Medical Monitoring Services

Safeguard your trial, while advancing science.

Ensure the safety and regulatory compliance of your medical device and pharmaceutical clinical trials with our comprehensive safety oversight and risk mitigation services

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We specialize in materiovigilance, post-market surveillance, and pharmacovigilance, providing a thorough approach to managing safety for medical devices and pharmaceuticals.

[Metric Ideas: #Clinical trials, #countries monitored]

Our Approach Safety and Monitoring Services

Advanced safety and Monitoring

Our experts combine expertise and regulatory knowledge with innovative technology to keep your trials safe and compliant, all while decreasing costs.

Achieve higher quality results with increased transparency, allowing you to monitor developments throughout your product's lifecycle.

Advanced Materiovigilance

We lead in monitoring the safety of medical devices and materials used in health products, ensuring their effective and safe use throughout their lifecycle.

Comprehensive Post-Market Surveillance

Our services include detailed tracking of medical device performance after market release, adhering to regulatory requirements and managing any safety concerns that arise.

Expert Pharmacovigilance

We also monitor the safety and effectiveness of pharmaceuticals, including drugs, vaccines, and biologicals, to ensure timely identification and management of adverse events.

Regulatory CompliancE

Our processes align with FDA and global regulations, ensuring thorough documentation and preparation for inspections.

Customized Safety Solutions

We tailor our safety management plans to address the specific needs of your medical devices and clinical trials, effectively managing risks.

Clincial Trial Services

Our Safety Management & Medical Monitoring Services

Materiovigilance

Safety Monitoring:
Oversight of the safety of materials used in medical devices and other health products, ensuring their effective and safe use.

Incident Reporting:
Management of incidents related to materials that may lead to adverse events, ensuring compliance with relevant regulations.

Post-Market Surveillance for Medical Devices

Device Reporting (MDR):
Comprehensive handling of device-related incidents, including malfunctions and adverse events, in line with regulatory requirements.

Performance Monitoring:
Continuous evaluation of medical device performance to identify and address safety issues.

Pharmacovigilance

Adverse Event Monitoring:
Systematic tracking and reporting of adverse events from clinical trials, post-marketing programs, and spontaneous reports.

Regulatory Reporting:
Submission of adverse event information to regulatory authorities for analysis and action.

Safety Process Management

Case Management:
Efficient processing of SAE report forms, data verification, and case booking to ensure accurate reporting.

Site and Sponsor Coordination:
Managing communication with sites and sponsors for case acknowledgment, query resolution, and updates.

Data and Documentation

Case Reports and Assessment Forms:
Preparation and review of case reports (CRFs) and assessment forms (CAFs), ensuring adherence to study protocols.

Safety Tracking:
Utilization of central safety trackers to keep sponsors informed on case status and completion.

Regulatory Submissions and Support

Safety Databases Management:
Handling regulatory submissions through safety databases and authoring aggregate safety reports (DSUR, PADER, PSUR).

Signal Detection and Risk Management:
Conducting signal detection and managing product quality complaints (PQCs) to mitigate risks effectively.

Additional Safety Support

Literature and Post-Marketing Studies:
Providing support for literature reviews and post-marketing safety studies.

Aggregate Reporting:
Creation and review of detailed safety reports to support regulatory submissions and ensure compliance.

"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 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.

"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

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.

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 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

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

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 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.