Clinical Trial Monitoring Services

From protocol to patient, your trial needs to run efficiently, accurately, and with integrity.

Ensuring the accuracy and integrity of clinical trial data is paramount. Our Clinical Trial Monitoring Services are designed to meet stringent requirements while safeguarding the reliability and quality of your study.

Proxima's experts identify, mitigate, and monitor risks throughout your trial's lifecycle, ensuring you are compliant with quality and regulatory requirements.

Engage

Our clinical research monitors meticulously oversee trial activities to ensure compliance with regulatory standards and adherence to the study protocol.

[Metric ideas: # of Clinical Trials]

Our Approach Trial Monitoring Services Types of Monitoring Visits

Proxima's COmprehensive Monitoring approach

Our comprehensive monitoring approach includes on-site and remote visits, data verification, and detailed reporting.

We focus on identifying and mitigating risks, ensuring subject safety, and maintaining data integrity throughout the trial. Our monitors are adept at recognizing potential issues early and providing actionable insights to keep your trial on track.

Experienced Clinical Research Associates (CRAs)

Highly trained with deep scientific and clinical expertise, our CRAs thoroughly understand your investigational product, protocol, and regulatory landscape.

Rigorous Clinical Trial Oversight

Our monitoring ensures trial data accuracy, completeness, and traceability, while maintaining strict adherence to protocols, GCP, and regulations.

Proactive Communication with Sites

Our team maintains constant communication with site staff to ensure timely data entry, resolve queries, and address any issues that arise during the trial.

Customized Monitoring Plans

Our tailored monitoring plans outline specific monitoring methods, responsibilities, and requirements, addressing the unique risks and needs of your study.

Clincial Trial Services

Our Clinical Trial Monitoring Services

Central Monitoring

Eligibility Criteria Assessment:
Determine key eligibility criteria through the collection of consent forms, scans, pathology reports, and statistical data.

Data Pattern Analysis:
Identify unusual patterns in data to ensure reliability and compliance.

Risk-Based Monitoring

Focus on High-Risk Areas:
Protect subject safety and ensure the reliability of trial results.

Risk-Based Approach:
Implement a risk-based approach following the 6 Rs: Risk Identification, Risk Evaluation, Risk Control, Risk Communication, Risk Review, and Risk Reporting.

On-Site Monitoring

Staff Training: Conduct staff training and provide access to necessary documents.

Resource Verification: Confirm the availability of pharmacy and lab resources.

Compliance Verification: Verify adherence to the protocol and GCP, check medical records, consent forms, eligibility, adverse events (AEs), and source data verification (SDV).

Types of Clinical Monitoring Visits

Site Qualification Visit (SQV)

Feasibility Assessment: Assess the feasibility of the site and investigator to conduct the study, ensuring all requirements are met for successful study conduct.

Interim (Routine) Monitoring Visit (IMV)

Data and Compliance Verification: Protect the rights and well-being of subjects, verify the accuracy and completeness of trial data, and ensure compliance with the protocol, GCP, and regulatory requirements.

Site Initiation Visit (SIV)

Study-Specific Training: Provide study-specific information to investigators and staff, reassess resources, review regulatory files, and ensure all documentation and procedures are in place before site activation.

Close-Out Visit (COV)

Trial Completion Assurance: Ensure all trial activities are reconciled, recorded, and reported appropriately at the end of the trial. Outline remaining investigator responsibilities and ensure readiness for regulatory authority inspection.

"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

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

“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 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

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

Junior Project Engineer

Karen Wells

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 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

"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 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.