Site growth

Starting a clinical research site: the first 12 months

By TrialNotice · Updated
Research team planning a new site around a table with documents and laptops
Short answerStarting a clinical research site takes a committed principal investigator, a trained coordinator, SOPs and quality systems, space and equipment, working capital, and a way to be found by sponsors. The first year is mostly preparation and the first one or two studies. New sites can win work, since sponsors look for research naive sites with new patient populations, but they must prove they can enroll.
This is a general overview, not legal or regulatory advice. Requirements vary by study type and sponsor.

What are the building blocks?

  1. A committed principal investigator. For drug studies under an IND, each investigator signs Form FDA 1572, an agreement to conduct the study per the protocol and FDA regulations (FDA). The commitment is real: in 2020, 66% of principal investigators filed only one 1572 (Tufts CSDD).
  2. A dedicated coordinator with the bandwidth to manage regulatory work, data, and patients. Sponsors look for this specifically (Bourne Partners).
  3. SOPs and quality systems, plus GCP training for everyone on the delegation log.
  4. Space and equipment: exam rooms, secure storage, and lab access.
  5. Working capital. Sites at SCRS recommended keeping at least three months on hand (Bourne Partners); first payments arrive well after startup work begins.

How does a new site get its first study?

  • Be findable: a clear research page on your website, and investigator registration on databases sponsors use, such as investigatordatabank.org (Bourne Partners).
  • Lean on what you have: sponsors look for research naive sites to reach new patient populations (Bourne Partners), and 28% of engaged sites are new relationships (Tufts CSDD).
  • Pick your first study carefully. A study you can fill builds the track record that brings the next one.

What does the first year look like?

  1. Months 1 to 3: entity, staff, SOPs, systems, website, registrations.
  2. Months 3 to 6: feasibility responses, first site qualification visits, contract and budget negotiation.
  3. Months 6 to 12: startup and first enrollment. Startup from site identification averages 31.4 weeks (Tufts CSDD), and only 62% of engaged North American sites activate (Tufts CSDD).

What is the biggest risk?

Enrolling too few patients in the first study. 37% of sites have under $1 million in revenue (SCRS), so one weak study hurts. A new site has no patient database yet, which makes local physicians its fastest patient source. Start those relationships while you wait for the first study.

Get your study in front of the right local physicians

TrialNotice builds a physician referral pipeline around one active study. We identify relevant local physicians within driving distance of your site, send study aligned direct mail, follow up by email and LinkedIn, track engagement with recipient level QR codes, and route warm responses into your site team's workflow.

Talk to TrialNotice

Sources

  1. FDA, "Frequently Asked Questions: Statement of Investigator (Form FDA 1572)"
  2. Tufts CSDD, first comprehensive clinical site initiation benchmark (2018), via GlobeNewswire
  3. Bourne Partners, "Update on the Fundamentals of Clinical Trial Sites" (SCRS Global Site Solutions Summit takeaways, October 2025)
  4. Applied Clinical Trials, "Tracking Change in the Global Investigative Site Landscape" (Tufts CSDD)
  5. Clinical Trial Vanguard, "Tufts CSDD: New Insights on The Clinical Trial Industry" (SCOPE 2024)
  6. Society for Clinical Research Sites, Site Finances White Paper (2024)

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