Site Startup & Feasibility

Your trial's success starts with site readiness.

Enhance your study's credibility and reliability with our clinical site identification and feasibility services that align with FDA requirements and any post-market needs. From study startup through enrollment, we help innovators move faster with confidence.
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Engage with our Team

Our clinical trial start-up process includes rigorous site assessments, a thorough feasibility evaluation, and strategic site selection to help you reach enrollment faster.

As a site-centric CRO with long-standing relationships across 125+ specialized clinical research sites, we support complex trials that other CROs simply aren't built for.

Our Approach Site Startup Services Our Process

clinical sIte startup for All Study Phases

Feasibility Studies

Pivotal Trials

Post-Market Surveillance / Ongoing Post-Market

IVD Clinical Studies

Real-World Evidence (RWE)

Seamless Clinical Study Startup to Accelerate Trial Success

Our comprehensive site startup services combine innovative tools and analytics to enhance your site identification, feasibility, and patient recruitment and retention, and milestone acheivement.

Whether you're managing a first-in-human study or a complex device trial, we make informed decisions early to mitigate costly risks and navigate complex regulations. Our dedicated Study Startup Specialists stay deeply involved from first site contact through activation, providing hands-on support.

Tailored Site SelectioN

We match your protocol to the best clinical research sites by evaluating patient population fit, investigator experience, and enrollment potential — ensuring your clinical research study startup is efficient and compliant from day one.

Extensive Expertise

Our team brings years of hands-on experience managing the clinical research site start-up process across complex therapeutic areas, ensuring accurate and timely execution.

Streamlined ProcesseS

Using a proven clinical trial study start-up checklist framework and long-standing site relationships, we minimize delays and expedite site readiness from identification through activation.

Dedicated Support

From site identification through activation, our Study Startup Specialists provide continuous, hands-on guidance to meet complex regulatory requirements and accelerate your clinical trial start-up process.

Clinical trial Services

Our Site Selection Services

Site Identification and Feasibility

Site Identification:
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, track investigator interest, and establish a realistic feasibility timeline.

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.

Informed Consent Form (ICF) Development:
Develop, review, negotiate, and approve ICFs tailored to each site's requirements, supporting your patient-centric solutions strategy from the start.

Site Payments Management:
Oversee and manage site payments to ensure timely and accurate disbursements, removing adminstrative friction from the site set up process.

Startup Management

Site Startup Plan Development:
Define processes and procedures for site initiation, 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 throughout the clinical study start-up phase..

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, maintaining momentum throughout the clinical trial start-up process.

Ongoing Support

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

Relationship Building:
Build strong relationships with clinical research sites to facilitate document collection, resolve issues quickly, and maintain the site-centric environment that leads to faster enrollment and better data.

Timelines and Follow-Ups:
Establish and monitor site-specific submission and approval timelines, ensuring all actions within the clinical trial study start-up process are completed efficiently and on schedule.

A Start-Up Plan Built for Your Trial

Our Study Startup Specialists execute a tailored clinical trial start-up process from feasibility through site activation, staying hands-on through every amendment and milestone so nothing slows your path to enrollment.

"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.

"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

"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.

Co-Founder

Jade Doucet-Martineau

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.