What an enrollment number hides in diligence.

A research network reports strong enrollment. The buyer sees a healthy total, a respectable sponsor list, and a pipeline of studies. What the total doesn't show is where the patients came from.

Phesi looked at 173 cancer trials covering 11,826 investigator sites and 83,916 enrolled patients. The top 16 percent of sites enrolled 54 percent of the patients. At the other end, the 19 percent of sites that enrolled exactly one patient contributed under 3 percent. Oncology isn't special here. In almost any network, a small group of sites, investigators, and coordinators carries most of the results.

Concentration is the real risk

When a few people produce most of the enrollment, the business is worth what those people are worth, and only for as long as they stay. Principal investigators carry sponsor relationships. Coordinators know which patients qualify for which studies. Referral relationships often belong to one physician, not to the company. If those people leave after the transaction, the enrollment leaves with them.

What to ask for

Ask for enrollment by site, investigator, study, and therapeutic area for at least the last three years. A total without that breakdown tells you very little. Then ask for screen failure and dropout rates, which show how well the site qualifies and keeps patients, and for the time from site selection to first patient in, which shows how quickly a new study turns into revenue.

Look hard at the sponsor mix. Repeat business from sponsors and CROs is one of the best signals in this industry, and heavy dependence on one sponsor is one of the biggest risks. Map the referral sources, too: which practices send patients, whether anything is in writing, and who keeps each relationship warm.

Finally, have counsel review whether the clinical trial agreements need sponsor consent for a change of control, and what the investigator agreements actually commit the investigators to.

Red flags worth slowing down for

• One investigator behind most of the enrollment.
• Referrals from a single practice with nothing in writing.
• High coordinator turnover in the last two years.
• One sponsor accounting for most of the revenue.
• Enrollment totals rising while screen failure rates climb.
• Standard operating procedures nobody has touched in years.

None of these ends a deal on its own. Each one changes what the business is worth and what the deal needs to protect.

Plan for the people

The most important diligence conversation often isn't about a spreadsheet. Meet the high-producing investigators and coordinators. Find out what keeps them there. Build retention into the deal before close, while it can still be negotiated.