US Clinical Trial Project Management

Your clinical trial needs to run on time, stay on budget, and include high-quality data.

Effective project management is the backbone of successful clinical trials.

Ensure your clinical trial progresses smoothly, hits milestones, and meets current regulatory requirements with comprehensive project planning, risk management, and resource allocation.

Engage

Our dedicated project managers oversee every aspect of your clinical trial, from planning and execution to monitoring and closeout, ensuring seamless coordination and timely completion.

[Metrics: %reduction in time from the last patient out to database lock on full-service studies, %faster time from final approved protocol to the first site initiation visit - SEE ICON]

Our Approach Trial Project Management Services Before You Start

Agile Trial Management

The regulatory landscape of clinical trials is constantly evolving with new requirements, technologies, and globalization.

Our team of experts help you navigate the intricacies of a clinical trial by staying up to date with the latest regulatory bodies and employing proven methodologies. We get your trial to completion by managing timelines, budgets, and deliverables, maintaining the highest standards of quality and compliance throughout the process.

Expert Coordination

Our project managers have extensive experience in coordinating all aspects of clinical trials, from planning and initiation to execution and closeout. They serve as the central point of contact, ensuring seamless communication and collaboration among all stakeholders.

Customized Solutions

We tailor our project management approach to fit your specific study requirements, adapting to the complexity and scope of your clinical trial.

Proactive Risk Management

Our team identifies potential risks early and implements effective mitigation strategies to avoid delays and ensure smooth trial progression.

Transparent Reporting

We provide regular updates and detailed reports, keeping you informed about the trial’s progress, milestones achieved, and any issues encountered.

Clinical trial Services

Our Clinical Trial Project Management Services

Clinical Trial Project Management

Study Protocol Development:
Collaborate with your team to develop detailed study protocols that meet regulatory requirements and study objectives.

Project Management Plan (PMP):
Develop a comprehensive project management plan outlining timelines, responsibilities, and deliverables.

Resource Allocation:
Ensure appropriate resource allocation, including staff, budget, and materials, to support the clinical trial.

Project Execution and Monitoring

Timeline Management:
Monitor and manage project timelines to ensure that all study activities are completed on schedule.

Budget Management:
Oversee the project budget, track expenses, and ensure that the study remains within financial constraints.

Quality Assurance:
Implement quality control measures to ensure that all aspects of the trial comply with regulatory standards and study protocols.

Stakeholder Coordination

Central Point of Contact:
Serve as the main point of contact for all stakeholders, including sponsors, investigators, CROs, and regulatory authorities.

Meeting Facilitation:
Organize and facilitate regular meetings to discuss study progress, address concerns, and make strategic decisions.

Issue Resolution:
Address and resolve any issues or challenges that arise during the trial, ensuring minimal disruption to study activities.

Risk Management

Risk Assessment:
Conduct thorough risk assessments to identify potential threats to the study’s success.

Mitigation Strategies:
Develop and implement risk mitigation strategies to minimize the impact of identified risks.

Contingency Planning:
Prepare contingency plans to address unforeseen challenges and ensure the trial remains on track.

Reporting and Documentation

Progress Reports:
Provide regular progress reports to keep you informed about the status of the trial, key milestones, and any issues encountered.

Regulatory Documentation:
Ensure that all necessary regulatory documentation is prepared, reviewed, and submitted in compliance with applicable guidelines.

Final Report Preparation:
Compile and present final study reports, summarizing the trial’s outcomes and insights.

A Good Place to Start

To begin your project management journey with Proxima CRO, consider the following steps:

Define OBJECTIVES

Clearly outline your study objectives and expectations to align our support with your clinical trial goals.

Engage with Our Team

Reach out to our expert project managers to discuss your specific needs and develop a tailored project management plan.

Share Study Details

Provide comprehensive details about your study, including protocols, budgets, and timelines.

"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

"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

“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 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

"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

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 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.