CRO Partnership 101: Three Things Founders Should Know Before Signing the SOW
1. “Capability” does not always mean readiness
One of the first questions founders ask a CRO is simple:
“Do you have ADCC capability?”
The answer may also sound simple:
“Yes, we have run ADCC before.”
“We have delivered ADCC data for multiple clients.”
“This is one of our standard assays.”
Those answers are useful, but they are not enough. A CRO having ADCC capability does not automatically mean the CRO is ready to run your ADCC assay — with your target, your preferred cell lines, your test articles, and your decision needs.
A CRO may have run ADCC successfully for common oncology targets using familiar cell lines and established controls. That experience matters. But if your program requires a different target, a specific target-density range, a less common cell line, or an engineered overexpression system, the work may shift from routine execution into assay development.
That shift should be recognized before the SOW is signed.
For example, if the CRO recommends a target-positive cell line, should you simply accept it, or should receptor density be confirmed first? If the CRO does not have your preferred line, will it need to be sourced, shipped, qualified, or engineered? If a stable overexpression line is required, are you prepared for months of delay and uncertain success? If transient expression is used instead, what decision can that system support — and what risk does it introduce?
None of these options is automatically wrong. The problem is when the tradeoffs are not explicit.
A second scenario is when the CRO says, honestly, that experience with your exact assay is limited, but they can explore and develop it. That may be acceptable, especially if you are trying to keep materials and workflows within one vendor. But convenience should not replace a development plan.
Before signing, ask:
What is already ready today?
What still needs to be sourced, qualified, optimized, or developed?
Where could the assay break?
What is the first feasibility gate?
What is the backup plan if the cell line, control, or readout does not work?
Who will drive troubleshooting if the first attempt is murky?
The goal is not to challenge the CRO aggressively. The goal is to avoid mistaking a capability statement for an execution-ready plan.
A strong CRO can be a valuable partner. But for founders, the key question is not only “Can you run this assay?”
It is:
“What parts of this assay are truly ready — and what parts are we still building after the SOW is signed?”
2. Scientific intent must survive the handoff
In many CRO partnerships, the person who sells or scopes the project is not the person who designs, runs, troubleshoots, or reports the assay.
This is especially common when client-facing teams and execution teams sit in different locations. Business development teams are trained to manage relationships, explain capabilities, and move proposals forward. Some BDs have strong technical depth. But even a technically capable BD is usually not the person carrying the scientific intent into day-to-day execution.
Sometimes an SME or technical expert is involved before the SOW is signed. This can be valuable. These people may understand the biology, assay strategy, and technical risks much better than a purely commercial contact. But founders should not assume that the SME will remain embedded once the work begins. In many CRO workflows, SMEs advise, scope, or troubleshoot — while execution is handed to PMs, technical leads, and lab teams.
That handoff matters.
By the time the assay reaches the lab, your program may no longer look like a scientific story. It may look like an internal work order: test articles, cell lines, assay format, timeline, and deliverables. The lab team may not have heard the original rationale. They may not know the target, the MoA, the ranking question, or why a particular control matters. To them, it may look like “just an assay.”
But biology does not work that way. Every assay choice is tied to scientific intent: the cells, the controls, the readout, the timing, the acceptance criteria, and how to interpret a weak or unexpected result.
Before signing, founders should ask:
Who carries the scientific context from pre-SOW discussion into execution?
Will the technical lead or lab team join the kickoff?
Is the SME directly involved after the project starts, or only available if trouble arises?
How is the assay rationale documented for the execution team?
If the target or MoA is confidential, who still understands what the assay is supposed to prove?
If the first result is murky, who decides the next step?
A strong handoff can save the founder from re-explaining the project at every turn. A weak handoff can send the team back to square one after the SOW is already active — sometimes with delays, extra meetings, and change orders.
Founders can choose to manage this themselves, and many do. Time-zone differences may not feel like a deal breaker at first. But the real question is whether this is the best use of founder time: staying up late, re-aligning the execution team, clarifying assay intent, and catching scientific drift in real time.
The point is not that CROs cannot execute. The point is that execution needs context.
Before the work begins, make sure someone is responsible for protecting the scientific intent — not only during the sales conversation, but all the way into the lab.
3. The CRO may drive operations, but you still drive the science
A CRO can help move the work forward operationally: scheduling studies, sourcing reagents, assigning lab teams, generating data, preparing reports, and managing timelines.
But operational ownership is not the same as scientific ownership.
If an assay runs smoothly, this distinction may not matter much. The CRO executes the plan, data are generated, and the founder can move to the next decision. But when the assay becomes murky — weak signal, failed positive control, poor assay window, donor variability, unexpected biology, or unclear ranking — the question becomes: who decides what to do next?
Do you repeat the assay? Change the cell line? Try a different effector source? Revisit the readout? Add a feasibility step? Stop and redirect the budget elsewhere?
Founders should expect to own those decisions.
A CRO may provide recommendations, and good technical teams can offer valuable input. But the CRO is not incentivized or structured exactly like the founder’s internal program team. Its job is to deliver the contracted work, manage scope, and keep projects moving. It may not be positioned to decide whether an assay is still the right assay for your program, whether a result is decision-useful, or whether your budget should be redirected to a different question.
This is where founders can fall into a risky assumption:
“You have run many of these assays before, so you must know the right way. Can you recommend what we should do?”
Sometimes the CRO can. Sometimes the answer will be useful. But founders should not passively wait for the CRO to define the scientific path, especially when the assay is not behaving as expected.
Before and during execution, ask actively:
What result would make this assay decision-useful?
What are the likely failure modes?
If the positive control fails, what is the next step?
If the assay window is weak, do we optimize, pivot, or stop?
What data would justify spending more?
What data would tell us this path is no longer worth pursuing?
The key is to stay ahead of ambiguity. Once the study is already delayed, the control has failed, or the team is debating a change order, it is much harder to recover time, budget, and clarity.
A CRO can support your program. It can execute important work. It can bring valuable technical experience.
But at the end of the day, the program is yours.
Own the scientific decision path actively — before the assay starts, while the data are being generated, and especially when the results are not clean.