Emergency and Acute Therapy Clinical Programs
Built around the moment, not the schedule.
Emergency and acute therapy trials are designed around a single clinical event: the moment a patient needs treatment. That design shapes everything, from how data is captured and how study drug is dispensed, to which sites can credibly observe an acute episode and how regulatory reviewers approach the protocol. Most eClinical platforms and CRO models were built for scheduled, chronic-disease trials. Sitero has worked in this category across more than 76 acute care programs and 237 neurology studies.
This is not a new category for us. Here is what the record shows:
Sitero has supported clinical programs evaluating sublingual spray, sublingual film, and intranasal spray delivery formats across acute CNS, acute pain, and antidote indications.
What Makes These Trials Different?
Emergency and acute therapy programs have a specific operational profile. Most vendors have not built for it. Three realities define clinical programs in this category. Each one has a practical consequence for how technology and operations need to be configured.
The endpoint is an event, not a visit.
In a rescue or acute therapy trial, the primary data point is typically the moment of administration and what happens in the minutes that follow. Time-to-relief measured in minutes. A seizure terminated or not terminated. Agitation resolved or escalating.
That is not how most EDC systems structure data capture. Standard visit-based architectures require adaptation to handle event-triggered capture, time-stamped administration records, and rescue medication use as the primary data rather than a secondary note. The configuration matters more than it does in a chronic disease trial because the primary endpoint depends on it.
The delivery format is not conventional.
Sublingual films. Intranasal sprays and powders. Buccal formulations. Autoinjectors with voice guidance. Drug-device combinations designed for lay caregiver use in an emergency.
Each format creates protocol and regulatory considerations that go beyond standard small-molecule oral or IV administration. RTSM must account for carry-out supply management, event-triggered dispensing, and drug accountability outside a clinic visit. IRB reviewers need familiarity with the specific risk-benefit questions this format category raises. Sites need staff who can document administration in a non-clinic setting.
Your team is managing high regulatory stakes with a lean structure.
The companies developing rescue and acute therapies are typically not large organizations. They are carrying NDA timelines, PDUFA dates, pivotal study launches, and international regulatory filings with clinical and regulatory teams of 10 to 30 people. When the vendors running your EDC, your RTSM, and your clinical operations are working from separate systems and separate contracts, the coordination overhead falls on your team. That is a structural problem, not a people problem.
With Sitero, the program determines the model. Not the other way around.
Some sponsors use Sitero for technology alone. Others use Sitero for full clinical operations. Many use both through an integrated engagement. The choice depends entirely on what the program needs and what infrastructure the sponsor already has in place.
Technology only
EDC, RTSM, eConsent, CTMS, and eTMF through the Mentor platform. Available independently of your existing CRO or operations partner.
Services Only
Site selection, monitoring, data management, and clinical operations. Available independently of your existing eClinical platform or technology vendor.
Fully integrated
Mentor platform plus full clinical operations under one contract and one accountable team. One point of contact from protocol activation through database lock.
IRB: Sitero operates an independent, AAHRPP-accredited IRB available as part of any engagement.
Why it matters for your program:
Emergency and acute therapy programs require eClinical configuration, site relationships, and operational experience in the specific therapeutic areas and delivery formats you are developing. Working with vendors who adapt general-purpose systems to your program is a different experience than working with a team that has done this before.
Ready to discuss your program?
Whether you are configuring technology for an active trial, scoping a Phase 2 program, or evaluating your vendor structure before a pivotal study launch, the starting point is a direct conversation with our clinical and BD team.
We will ask about your program, your current infrastructure, and your timeline. If there is a fit, we will tell you specifically why. If there is not, we will tell you that too.
