For sponsors & CROs
Judge us on cycle time, retention and clean data.
We would rather be measured than marketed. Below is how we run and report performance, and the operating commitments behind it.
Typical turnaround on a sponsor feasibility questionnaire
Core therapeutic areas with active investigator depth
Operating today from Ponce, Puerto Rico under FDA oversight
Phases of study delivery supported end to end
Operational capabilities
The operating discipline, not the brochure.
Sponsors select sites on execution, not adjectives. These are the operational measures we manage a study by, what each one governs, and how it is reported.
Operational capabilities · site network
The measures we manage a study by
Rapid site activation
Regulatory pathways, contract templates, investigator agreements and staff training packages are established before a protocol arrives, so activation is an execution step rather than a build.
Why it matters — Determines how quickly a sponsor's protocol begins generating data after site selection.
Disciplined enrollment execution
Enrollment is planned from a known, health-system-connected population, tracked weekly against commitment, and escalated the moment a site trends behind plan.
Why it matters — Predicts whether a study reaches its cohort without rescue sites or timeline extensions.
High patient retention
Bilingual coordinators, transportation coordination and proactive visit-window contact keep participants in the study through the final visit.
Why it matters — Dropouts erode statistical power; retention protects the evaluable dataset a submission rests on.
Low protocol deviation rates
Visit windows, dosing and assessment schedules are monitored against protocol in real time, with corrective action documented and closed rather than noted.
Why it matters — Deviation frequency is the clearest proxy for GCP discipline and inspection readiness.
Responsive query resolution
Query aging is reviewed on a fixed internal cadence — not when a monitoring visit is scheduled — so open items are resolved while source documentation is still fresh.
Why it matters — Query aging is the leading cause of database-lock delays between last visit and topline results.
Accurate feasibility & screening
Feasibility answers are grounded in the population we can actually reach, which keeps screen-failure rates controlled and forecasts honest.
Why it matters — Realistic feasibility means less wasted screening spend and fewer mid-study corrections.
Inspection-ready documentation
Submissions, amendments, safety reporting and essential documents are owned by one accountable regulatory function across every site.
Why it matters — Documentation integrity is what holds up when a sponsor audit or FDA inspection arrives.
Study-level reporting
Each capability above is reported per study and per site on a weekly cadence, with escalation on any measure trending away from commitment. Study-specific performance history is released under confidentiality during feasibility review.
Institutional partnership
We plug into established hospitals — and run the research to their standard.
Feasibility through submission support, delivered inside the institution's governance, pharmacy and IRB structures rather than around them.
Animated pipeline
Phase 1 to regulatory submission, with the controls at every stage.
This is the operating pipeline we bring to hospital partners and sponsors: cohort scale, site count, duration and the specific controls that hold each stage together.
Hospital research pipeline
How Aspira partners with established hospitals for Phase 1–3 research
2–6 weeks · 1 institution
Stage 00
Hospital partnership & feasibility
Joint feasibility with hospital leadership, investigators and pharmacy: population access, unit capacity, IRB pathway, budget and coverage analysis. We commit to numbers only after the chart-level review.
Operational controls at this stage
Population access confirmed
100%
Investigator & pharmacy alignment
92%
Regulatory pathway mapped
88%
Indicators reflect Aspira's internal operating standards and aggregated historical performance. Study-specific figures are shared under confidentiality during feasibility.
Enrollment performance
Speed comes from access, not pressure.
Health-system partnership in Puerto Rico and community-embedded recruitment mean we start screening from a known population rather than building one after activation.
Days from site selection to first patient in
64%
Screen-failure rate per enrolled participant
71%
Enrollment against target commitment
112%
Indexed against Aspira's internal historical benchmark set at 100%. Study-specific performance is provided under confidentiality during feasibility review.
Retention & quality
Retention is an operations problem, and we treat it that way.
Participant retention
Transportation coordination, bilingual staff and scheduled follow-up contact across visit windows.
Protocol adherence
Visit-window compliance tracked weekly per site with escalation before deviations occur.
Source data completeness
Documentation reviewed on a recurring internal cadence, not before monitoring visits.
Operations review
Weekly enrollment, deviation and query-aging review across every active site — the same report sponsors receive.
Data discipline
Endpoint-ready datasets built for regulatory scrutiny, not reconstructed for it.
Regulatory submissions handled per year (indexed)
Growth in regulatory and IRB submission volume managed by Aspira's internal regulatory function.
Regulatory track record
Documentation discipline that holds under inspection.
Our regulatory function owns submissions, amendments, safety reporting and essential-document integrity across every site, with a single accountable point of contact for sponsors and monitors.
What you get
Commitments we put in writing.
Named delivery team
A project lead, regulatory lead and site lead identified before contract execution.
Weekly metric reporting
Enrollment, screen failures, deviations and query aging in one recurring report.
Escalation within 24 hours
Any risk to timeline or safety reporting is surfaced same-day, not at the next meeting.
Phase 1 access in Puerto Rico
One of few PR organizations equipped for Phase 1, with a US regulatory framework.
Next step
Send us the protocol synopsis.
We will respond with site availability, population feasibility and a start-up timeline within three business days.