Lauren Alani, Director of Digital Innovation at Seuss+, on why defining trial-level requirements before selecting clinical technology is the only way to make a defensible procurement decision.
The data behind this perspective
- ACRP 2024 global survey, ~850 sites · 19% of sites cited sponsor-provided technology as a top operational challenge
- ICH GCP E6(R3) Essential Documents · documentation of vendor selection, assessment, and oversight is an essential document, required to be in place prior to the start of the study
- ICH GCP E6(R3) §3.6.7 · the sponsor is responsible for assessing the suitability of and selecting service providers, ensuring they can adequately undertake the activities transferred to them
- The User Requirements Specification · the sponsor-authored, vendor-neutral document that translates trial-level data, regulatory, and operational needs into objective scoring criteria; built before any vendor presents
- Lauren’s analogy (her own) · “Selecting clinical technology before defining requirements is like buying a sofa without measuring the room. The sofa may be exactly what you wanted. If it does not fit, you will only know after it has been delivered.”
“If you let the vendor define the scope of the selection conversation, you have already lost the objectivity of the decision.”
Lauren Alani
Most clinical technology selection processes I have observed run roughly like this. A sponsor identifies a need (eCOA, ePRO, EDC, IRT, eConsent, wearables, you name it). The clinical operations team requests demos from three or four vendors. Demos are shown, scored against a feature matrix, and compared on price. A vendor is selected. Implementation begins. The trial-specific requirements get translated into the chosen platform’s structure, often with friction, because the structure was not designed around this trial; it was designed around the vendor’s standard offering.
The sequence is reversed. The trial’s needs should drive the selection; the selection should not drive the trial’s design. When the order is reversed, the cost shows up later, sometimes much later, in mid-trial system changes, validation rework, oversight blind spots, and inspection findings nobody anticipated at procurement.
The vendor demo problem
Vendor demos are commercial artefacts. They are designed by the vendor’s product marketing team to showcase the platform’s strengths. They are not designed to expose its constraints in the context of a specific trial. The demo’s narrative is built around the use cases the vendor is best at; the trial’s needs may sit anywhere across that landscape, including in the corners the demo did not visit.
A sponsor team scoring a demo is, in effect, evaluating the vendor’s marketing team. That is not what it should be evaluating. It should be evaluating the platform’s fitness for the specific trial, against trial-level requirements the sponsor has authored independently of the demo. Without those requirements, the demo is the de facto specification, and the platform’s strengths become the trial’s structure.
The danger of that assumption is that the trial inherits the platform’s design choices, including the choices the trial would not have made on its own. Some are minor inconveniences. Others surface as oversight gaps months in.
What “requirements” actually means
Requirements, in this context, are not a feature checklist. A feature checklist asks: does this platform support electronic signatures, audit trail, multi-language, role-based access? Most reputable platforms tick most boxes. The checklist tells the sponsor very little about whether the platform fits the trial.
Requirements are the trial-specific articulation of what data must be captured, how it must move, what regulatory expectations it must meet, what oversight points the sponsor needs to evidence, and what integration touchpoints exist with other systems in the trial’s architecture. They derive from the protocol, the regulatory framework, the data flow, the sponsor’s quality system, and the realistic assumptions about how this trial will be run, by whom, in which countries, with which sites.
Authored well, a requirements document is 30 to 80 pages. It takes weeks to produce. It is signed off by the sponsor’s clinical, data management, regulatory, and quality leadership. It is then used as the basis for vendor RFPs, demo questions, configuration specifications, and validation acceptance criteria. It is, fundamentally, the sponsor’s document. Vendors respond to it; they do not author it.
What changes when requirements come first
When the sponsor leads with requirements, several procurement-stage dynamics shift in the sponsor’s favour.
First, the demo conversation changes. Instead of “show us what your platform does,” the question becomes “here are 12 specific scenarios drawn from this trial; walk us through how your platform handles each.” Vendors are forced into the trial’s frame, not their own. Strengths and constraints surface in context. The sponsor’s evaluation team is no longer scoring marketing; it is scoring fit.
Second, the contracting conversation changes. The sponsor’s requirements become the basis for the SOW, not the vendor’s standard scope. The vendor’s deliverables are framed around the sponsor’s needs. Validation acceptance criteria are pre-defined. Change control is anchored to sponsor-defined baselines. The contract is harder to negotiate at the start. It is significantly easier to manage later.
Third, the oversight evidence is structurally easier. The sponsor’s requirements document becomes the spine of the validation package. Each requirement maps to a vendor deliverable, an acceptance test, and a piece of operational evidence. The sponsor’s oversight records build naturally as the trial progresses. By the time an inspector or auditor asks for evidence, the records have been accumulating in the right structure for months.
Why sponsors skip this
The procurement timeline is the usual culprit. A sponsor team is told the trial needs to start in 90 days and the eCOA has to be selected, contracted, and configured before then. There is no time to author a 60-page requirements document. So the team goes to the demos and chooses fast.
This timeline pressure is real. It is also frequently self-inflicted. The sponsor’s leadership set the start-date target without budgeting for the requirements work, because the requirements work is invisible until it is missing. The cost of skipping it shows up later, after the leaders who set the target have moved on to the next milestone.
The other reason sponsors skip this is internal capability. Authoring trial-level requirements documents requires people who can read the protocol, the regulatory framework, the data flow, and the operational reality, and synthesise them into a coherent specification. This is a senior skill set. Many sponsor teams do not have it on staff; many do, but those people are already over-allocated. The work then moves to a CRO or to the vendor, both of whom have a perspective and an interest, and neither of whom is the right author for a sponsor specification.
The minimum viable version
If 60 pages and several weeks is not realistic, there is a minimum viable version. It is not a substitute for the full discipline; it is an intermediate posture that prevents the worst failure modes.
Author a 5 to 10 page document that articulates: the trial’s data flow at a high level, the regulatory frameworks that apply, the most critical sponsor oversight points (typically 4 to 8), the integration touchpoints with other systems, and the top 10 to 15 trial-specific scenarios that the chosen platform must support. Use this as the basis for vendor demos and SOW negotiations. Expand it into the fuller specification during implementation, ideally before validation begins.
This minimum viable version is not the right answer. It is the right compromise. It moves the sponsor’s procurement-stage posture from “evaluating vendor demos” to “evaluating vendor fit against trial-specific scenarios,” which is a meaningful shift even at limited document depth.
The closing question
For your most recent clinical technology selection, was the decision document anchored in your trial’s specifications, authored by your team, signed off by your quality leadership? Or was it anchored in a vendor demo and a feature comparison? The two artefacts produce very different downstream evidence. The work is to know which one you have, and to author the other before the next selection.
Continue reading: Data Integrity Is a Commercial Risk, the perspective that makes the cost of weak procurement decisions explicit. The Regulator-Vendor Gap for the structural context. All four perspectives in the insights archive. To bring this perspective to your team or stage, see media and booking.
Frequently asked
How long should a trial-level requirements document take to author?
For a typical biotech sponsor selecting a clinical platform, the full discipline takes 4 to 8 weeks of focused effort, parallel to other work. The minimum viable version takes 1 to 2 weeks. The cost of not authoring it scales with trial complexity, the platform’s reach into the data lifecycle, and the regulatory exposure of the asset under development.
Can a CRO or the vendor author the requirements on the sponsor’s behalf?
They can contribute, but they should not be the primary author. Both have a perspective: the CRO toward delivery efficiency, the vendor toward the platform’s strengths. The sponsor’s perspective (regulatory accountability, asset value, oversight evidence) needs to be authored by the sponsor, even when other parties contribute. The signed-off document has to come from the sponsor’s quality system.
What’s the most common failure mode when sponsors skip this step?
Mid-trial discovery that the platform does not support a specific oversight scenario the sponsor needs. The platform is already validated, the trial is already running, and the change cost is high. Common variants: edit checks that don’t fire on the right conditions, audit trails that don’t capture the relevant change events, integrations with other systems that lose data lineage. All of these are caught by upfront requirements work; none are typically caught by demos.
Does this apply equally to all clinical platforms (eCOA, EDC, IRT, etc.)?
The principle applies across the board. The execution depth scales with platform criticality to data integrity. EDC and eCOA, which sit centrally in the data lifecycle, justify deeper requirements work. IRT and eConsent, which are more transactional, need lighter but still trial-specific requirements. The sponsor still authors. Vendor still responds.
Where does AI-enabled tooling fit into requirements before selection?
The same principle applies, with an additional layer: the sponsor must specify what AI is doing in the data lifecycle, where its outputs feed regulatory artefacts, and what controls are in place. AI tools that operate on regulated data without sponsor-specified controls are a regulator-vendor gap accelerant. Define the AI’s role in your trial, in your specification, before the vendor selects it for you.
