Why should I consider Milestone One to support clinical research at my practice? 

Milestone One helps you expand your practice into clinical research with no prior research experience required. With a global footprint across more than 20 countries, our team provides operational and administrative support to guide your practice through every study. 

We emphasize clarity in how studies are structured and what is expected. We also do not require exclusivity; your level of involvement is entirely your choice. 

At Milestone One, we identify clinical practices based on their expertise, which strengthens our ability to secure meaningful clinical trials for you. Additionally, we help promote your research capabilities and bring forward study opportunities that you may choose to participate in. 

Who can become a clinical trial investigator? 

You do not need to be associated with a medical school or teaching hospital to qualify as a clinical investigator.  At Milestone One we welcome the opportunity to work with physicians who are motivated to bring research opportunities to their patients. We provide the tools, training, and support to begin your research journey confidently.   

Why should I consider becoming a clinical trial investigator? 

Clinical investigators play an important role in advancing medical innovation and improving patient care. By participating in clinical research, you will: 

• Stay at the forefront of therapeutic innovation in your areas of specialty 
• Expand your professional profile as a thought leader in your community 
• Open an additional revenue stream for your practice 
• Offer your patients access to novel treatments available only through research 
• Contribute directly to the evolution of modern medicine 

 Milestone One simplifies the path to research participation, handling the complexities so you can focus on your patients.   

How will I become part of your research network? 

We first assess your therapeutic focus, patient population, and interest in participating in research. If there’s alignment, our team supports everything you need to get started, including study identification, clinical coordination, administrative setup, regulatory oversight, and ongoing site enablement.  

What services does Milestone One provide? 

Milestone One is a Site Enablement Organization. Our services include:  

• Access to a broad range of clinical studies 
• Full-site operational setup and management 
• Site coordination and administrative support, delivered through Milestone One’s services
• Regulatory document preparation and oversight 
• Patient identification and recruitment support 
• Data management and reporting 

Our model is designed to remove operational burdens, allowing you to focus on quality care and research excellence. 

How do I know if clinical trial investigation is right for me? 

The key factor is that you have an interest in expanding access to innovative treatments for your patients. If you are willing to engage in a structured process, Milestone One provides the operational, regulatory, and administrative support you need to succeed.   

Before moving forward with a study, we collaborate with you to assess:  

• Whether the study aligns with your patient population 
• Enrollment feasibility and site capacity 
• Protocol demands and resource requirements 
• Your comfort and readiness to engage in clinical research activities 

How do I incorporate clinical trials into my practice? 

Clinical trials require regulatory compliance, documentation, and patient engagement. We build a cooperation with you to handle daily operations, from study setup to closeout, integrating seamlessly into your existing practice workflow.  

What happens when I am selected to be a clinical trial investigator? 

If your site is selected for a study, our team facilitates each step of activation. You will review forms, including study protocol and an investigator drug brochure, if applicable, describing what is known about the investigational drug. Milestone One coordinates directly with sponsors and CROs, managing scheduling, communication, and all regulatory documentation. You will have continuous support from our team throughout the process.  

What are the general responsibilities of a clinical trial investigator? 

• The investigator must ensure that a study is conducted according to the protocol and Good Clinical Practice guidelines and applicable regulations 
• Research staff are trained in the study requirements 
• Patients are presented with all the available information to make an informed decision regarding participation 
• Patient safety will remain a top priority 
• The investigator must schedule time to meet with the sponsor/representative for interim monitoring visits 
• Timely review patient results for adverse event findings and report as appropriate 

Milestone One assists with obtaining informed consent of each study participant to whom the drug is administered, managing documentation, and maintaining communication with sponsors to ensure adherence to study requirements.  

What kind of training and support does Milestone One provide to the principal investigator?  

The first required training is an online, self-paced course called Good Clinical Practice (GCP) training, which includes certification upon completion. This standardized program educates clinical research professionals on the ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials involving human participants.  

Milestone One will facilitate registering your team for the free training, or you are welcome to choose the best program for your team. GCP training is mandatory for all investigators, study coordinators, and research staff before participating in clinical trials.  

Can the other physicians in my practice be involved in the same studies in which I participate as principal investigator? 

Yes, they may participate as sub-investigators if it is acceptable to the sponsor/CRO, and appropriate regulatory documentation is submitted before their involvement in the study begins.  

What demands will there be on my time if I become a clinical trial investigator? 

Overall, the time commitment for each study is designed to be minimal and manageable alongside your clinical responsibilities. While the exact amount of time may vary depending on the complexity of the trial, most research activities are supported and facilitated by Milestone One staff to ensure the process runs smoothly and does not interfere with your clinical practice. Initial onboarding is the most time-intensive portion, after which our team handles the majority of ongoing study-coordination tasks. 

What is my insurance risk if something happens to a subject during the study? 

Most clinical research sponsors, particularly in industry-sponsored trials (e.g., pharmaceutical or biotech companies), typically provide indemnification to the principal investigator (PI) and the institution/site, through the clinical trial agreement (CTA). 

This is a common industry practice worldwide, aligned with ICH E6 Guideline for Good Clinical Practice (GCP) (Section 3.14.1), which states that the sponsor should, if required by applicable laws, indemnify the investigator/institution against claims arising from the trial, except for those arising from the investigator’s malpractice and/or negligence. 

What is the timeframe from when we formalize our collaboration with you to when we might go live with our first study? 

Once our agreement is fully executed, we immediately begin building your practice profile. This includes conducting onsite visit(s), scheduling required training for the principal investigator and study team, and supporting study activities at your site through Milestone One site coordination support services.    

The preparation phase typically takes 30–40 days to get your site ready to accept its first study. Once your site is selected for a clinical trial, the study startup process generally takes an additional 30–60 days, depending on the type and size of the trial. 

What is the typical compensation per study? 

Compensation varies depending on each study’s complexity, duration, and enrollment targets.  

What is an Institutional Review Board or a 
Research/Independent Ethics Committee? 

An Institutional Review Board (IRB) or a Research/Independent Ethics Committee (EC) is an independent body responsible for protecting the safety and rights of individuals who participate in clinical research. In the United States, this body is commonly referred to as an IRB, while in countries outside of the US, similar oversight is provided by the ECs.  

Every clinical trial conducted in collaboration with Milestone One is reviewed by the appropriate accredited ethics committee before the study begins and remains under its oversight throughout the study’s duration. This independent review process plays a critical role in safeguarding study participants and ensuring research is conducted ethically and in compliance with applicable regulations. 

To learn more about bringing clinical research to your practice, visit our website or contact Milestone One at contact@milestoneone.com