Site Startup & Success

The success of your clinical trial starts with selecting the right sites.

Enhance your study's credibility and reliability with our site identification and feasibility services that align with FDA requirements and any post-market needs.
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Engage

Our approach includes rigorous site assessments, a thorough feasibility process, and strategic site selection to help set you up for success from the outset.

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Our Approach Site Startup Services before you start

Seamless Site Startup to Accelerate Trial Success

Our comprehensive services combine innovative tools and analytics to enhance your site identification, feasibility, and patient recruitment and meet your milestones.

Make informed decisions early on to mitigate costly risks and navigate complex regulations.

Tailored Site SelectioN

We work hard to ensure you have the best sites for your product. Our experienced team conducts detailed evaluations to identify sites with the appropriate patient population, necessary infrastructure, and experienced investigators. We prioritize sites that demonstrate high enrollment potential and adherence to regulatory standards, ensuring your trial's efficiency and compliance from the outset.

Extensive Expertise

Our team has years of experience in managing site startup processes, ensuring accurate and timely execution. We understand the intricacies involved and are adept at navigating potential challenges

Streamlined ProcesseS

We simplify the site activation journey, helping you avoid common pitfalls and expedite site readiness. Our proven methodologies and strong relationships with sites minimize delays and optimize trial timelines.

Dedicated Support

From site identification to activation, we provide continuous support and clear communication to ensure effective site management. We are committed to being hands-on and flexible, providing educational resources and detailed guidance to meet complex regulatory requirements.

Clinical trial Services

Our Site Selection Services

Site Identification and Feasibility

Site Identification:
We identify and contact potential investigators and sites ideal for your study, ensuring they meet protocol and study needs.

Feasibility Questionnaire:
Develop and review feasibility questionnaires to assess site capabilities and track investigator interest.

Site Qualification:
Conduct site qualification visits and investigator debarment checks to ensure compliance and suitability.

Site Activation

Essential Document Collection:
Develop and review essential document templates, manage document collection, and ensure compliance with ICH-GCP guidelines and federal regulations.

Central IRB Submissions:
Handle central IRB submissions for multicenter trials, ensuring timely approvals and adherence to regulatory requirements.

Informed Consent Form (ICF) Development:
Develop, review, negotiate, and approve ICFs tailored to each site's requirements.

Site Payments Management:
Oversee and manage site payments to ensure timely and accurate disbursements.

Startup Management

Site Startup Plan Development:
The Site Startup Plan defines processes and procedures for the initiation of study sites, including site qualification, initiation, and activation. This plan ensures that study sites are set up and ready to enroll subjects in a timely and efficient manner.

Site Activation Meetings:
Conduct Study Startup (SSU) calls and teleconferences with sponsors to present site activation plans and site status updates.

Coordination with CRAs:
Liaise with Clinical Research Associates (CRAs) to forecast Site Initiation Visit (SIV) dates and manage the transition from startup to site activation.

Ongoing Support

Document Management:
File all documentation in the Trial Master File (TMF) and coordinate across functional areas to prioritize and process documents.

Relationship Building:
Build strong relationships with sites to facilitate document collection and address any issues promptly.

Timelines and Follow-Ups:
Establish and monitor site-specific submission and approval timelines, ensuring all actions are completed efficiently.

A Good Place to Start

To begin your site startup journey with Proxima CRO, consider the following steps:

Define Goals

Clearly define your study goals to align our support with your regulatory strategy and market plans.

Engage with Our Team

Reach out to our expert team to discuss your specific needs and develop a tailored site startup plan that ensures compliance and readiness.

Gather Information

Provide detailed information about your study, including protocol requirements, investigator details, and site preferences.

"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

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

Junior Project Engineer

Karen Wells

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 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 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

“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."