Sites and CROs Are Still Waiting for Sponsors to Solve a Problem Only They Can Fix Themselves
Feasibility questionnaires arrive without context, ask for information sites have provided a dozen times before, and consume hours of expert time that nobody compensates. Waiting for sponsors to change that is a losing strategy.
Sites and CROs that own their own protocol intelligence do not wait.
There is a conversation that happens in almost every site director meeting, every research coordinator forum, and every CRO operations review at some point. It goes something like this: why are we filling in the same feasibility questionnaire again, for a different sponsor, asking the same questions we answered three months ago for someone else, with no protocol context to work from, and no payment for the hours it takes?
It is not a new complaint. And it has not been solved, despite being one of the most consistent sources of friction in the site-sponsor relationship. Understanding why it persists, and where the fix actually sits, matters more than acknowledging the frustration.
Why Sites Keep Answering the Same Questions!!
The repeated questionnaire problem has a straightforward structural explanation. There is no universal site profile. Every sponsor, every CRO, every SMO has their own feasibility template, developed internally, formatted to their own preferences, asking for information in their own sequence. A site that has completed feasibility assessments for ten different sponsors holds ten different records of the same information, scattered across ten different formats, none of which carry forward to the next request.
Efforts to standardise this have been ongoing for years. TransCelerate, various site networks, and CTSA consortium initiatives have all worked toward a persistent, portable site profile. Progress has been real but adoption has been incomplete. In the meantime, sites continue to answer from scratch every time, and the hours consumed in doing so are almost universally unbillable.
A site completing twelve feasibility questionnaires per year will typically win one or two studies. The other ten or eleven submissions are unbillable hours spent on proposals that return nothing. That is a win rate of under 17 percent on time the industry has never priced and never compensated.
The volume compounds the problem. As registered clinical trials have grown by over 30% since 2020, the number of feasibility requests reaching sites has grown with them. More sponsors, more CROs, more questionnaires, the same coordinator team, the same unpaid hours. For smaller sites and community practices, the feasibility burden has become a genuine deterrent to engaging with research at all.
The Second Problem Nobody Talks About
The repeated questionnaire frustration is visible and widely discussed. There is a second problem that sits underneath it that receives less attention: most feasibility questionnaires arrive without the upstream protocol context that would allow a site to answer them accurately and efficiently in the first place.
A sponsor or CRO sends a questionnaire asking whether the site can support a study. What visit schedule? What procedures? What patient population? What equipment requirements? Without a clear protocol brief, the site answering those questions is either reading the full protocol themselves, often a document of 150 to 200 pages, to extract that context, or answering from prior experience and making assumptions that may or may not reflect what the study actually requires.
Both approaches have a cost. Protocol reading consumes hours of clinical expertise that should be directed at patients. Assumption-based answering produces responses that undersell or mismatch the site's actual capability, which affects selection decisions and ultimately whether the site wins the study.
Option one: Read the protocol themselves
Hours of senior coordinator or investigator time consumed in technical document reading before a single questionnaire field is completed. Unbillable. Not why they trained in clinical research.
Option two: Answer from assumptions
Faster but introduces errors. Responses that do not accurately reflect study requirements lead to mismatched site selections and avoidable failures mid-study. Everyone loses.
Option three: Do a partial job
Coordinators without capacity for either option above submit incomplete responses. Sites with genuine capability are overlooked because their feasibility submission undersells them. Sad but Damaging.
What this means in practice is that the sites most likely to submit thorough, accurate feasibility responses are not necessarily the sites best suited to run the study. They are the sites with the most administrative capacity. That is a selection distortion the industry has largely accepted as normal. This is why the one and done site scenario keeps repeating itself!
The win rate makes this worse in a specific way. If a site knew in advance which one or two studies it would be selected for, it would invest properly in those responses and decline the rest. But sites cannot know that. So the rational response is to calibrate effort downward across all twelve submissions. Responses become templated, partial, and progressively less accurate over time because the economics of investing fully in every questionnaire do not make sense when the expected return on any individual submission is one in six or fewer. The feasibility data sponsors receive has been quietly degraded by the economics of the process itself.
The Dependency That Sites and CROs Need to Stop Accepting
There is a version of this problem that puts the obligation on sponsors to provide better context before asking sites to respond. That version is correct in its diagnosis. It is passive in its remedy. Sponsors have been inconsistent in what they provide alongside feasibility questionnaires for as long as feasibility questionnaires have existed. Waiting for that to change is not a strategy. It is hope. Yes we can always be hopeful!!
The more useful question is this: what does a site or CRO do when the protocol arrives and the sponsor has not provided a plain-language brief, a visit schedule summary, a key evaluations extract, or any of the contextual documentation that makes a feasibility response accurate? The answer, until now, has been to absorb the cost and do the extraction manually. That is the dependency. And it is one that sites and CROs have the capability to eliminate themselves.
The moment a protocol arrives, in any form, from any sponsor, a site or CRO with Clinials generates its own brief. Its own plain-language summary. Its own visit schedule. Its own key evaluations. Its own eligibility criteria in accessible language. That capability does not depend on what the sponsor chose to include in the package. It does not depend on the sponsor's operational maturity or goodwill. It belongs to the site or CRO that owns it.
What Ownership Changes for Sites
A site that generates its own protocol intelligence from day one is no longer in a passive position in the feasibility process. It does not wait to find out whether this sponsor provides context or not. It produces a complete, accurate basis for its feasibility response within hours of protocol receipt, regardless of what arrived alongside it.
That independence compounds across every submission. In a process where the win rate sits below 17 percent, the sites that consistently submit accurate, thorough responses are the ones that win more than their share. The sites calibrating effort downward because the task is too expensive to do properly every time are the ones whose win rate reflects that calibration. Owning protocol intelligence changes the economics of every submission, not just the ones where the sponsor happened to provide good context.
The ownership argument extends beyond feasibility. A site that generates its own protocol intelligence on day one is also ahead on the patient information sheet, the billing documentation, the operational synopsis, and the recruitment materials. None of those depend on the sponsor providing them if the site has already generated them from the protocol. Feasibility capability and startup capability are the same tool applied at two points in the study lifecycle. The site that owns one owns both.
Waiting on the sponsor
Response quality depends on what sponsor provides
Manual protocol extraction when brief is absent
Effort calibrated down across all submissions
Win rate reflects sponsor's operational maturity
Startup documents follow weeks after feasibility
Owning protocol intelligence
Brief generated on day one regardless of sponsor
Accurate responses on every submission, every time
Full effort justified because cost per response drops
Win rate reflects site capability, not sponsor quality
Startup documents ready the same day as feasibility
What Ownership Changes for CROs
The same dependency exists at the CRO level and carries the same commercial risk. A CRO that waits for a sponsor to provide protocol context before distributing feasibility packages is building its activation timeline around the sponsor's document preparation schedule. That is not a position any CRO with a competitive mandate should be comfortable occupying.
A CRO that owns its own protocol intelligence generates the feasibility brief the moment the protocol arrives and distributes a complete, plain-language package to every site on day one. It does not absorb the delay while the sponsor catches up. It does not send sites a questionnaire without context and then manage the consequences of incomplete, assumption-based responses. It controls the quality of its own feasibility process from the first document it receives.
That control has a direct commercial value in sponsor conversations. CROs are measured on activation speed and site selection quality. Both metrics are upstream of anything the sponsor controls once the protocol is handed over. A CRO that demonstrates it generates superior feasibility documentation faster, from its own capability rather than in dependence on sponsor-provided materials, is presenting evidence of operational differentiation that sponsors measure CROs against in every performance review and every new business conversation.
There is a margin argument too. CRO feasibility teams building packages manually from protocols are consuming overhead that scales with study volume. Owning protocol intelligence through Clinials converts that overhead into a fixed capability. The CRO grows study volume without growing the feasibility team proportionally. That is the scale argument that CRO COOs and commercial directors understand immediately.
The Shift Worth Making
Clinials does not solve the repeated questionnaire problem. Sites will still receive questionnaires in different formats from different sponsors. The absence of a universal site profile is an industry-wide structural issue that no single tool resolves.
What Clinials eliminates is the dependency on sponsors to make the feasibility process workable. Sites and CROs that own their protocol intelligence capability are not asking sponsors to behave better. They are removing the variable that made sponsor behaviour consequential in the first place. That is a more durable competitive position, and it is available now, from a single protocol upload, in the same session as the protocol arrives.
Clinials · Protocol Intelligence
Own your protocol intelligence. Stop waiting for the sponsor to make feasibility workable.
Clinials generates a complete, plain-language protocol summary for feasibility from a single upload on the day the protocol arrives. Visit schedule, key evaluations, patient population, unique equipment, eligibility criteria. Everything a site or CRO needs to produce an accurate, competitive feasibility response, available in minutes, regardless of what the sponsor provided.
