Unified Clinical Research Software for Sponsors Maintaining Oversight Across Delegated Trial Execution
AQ helps mid-market biotech and emerging sponsors maintain oversight across CROs, sites, and vendors — without building a Veeva-scale infrastructure on day one. Built for Sponsor QA Directors, Heads of Clinical Operations, and Quality Leads accountable for inspection readiness, CAPA management, and audit-ready evidence across delegated trial execution. Aligned with ICH E6(R3), 21 CFR Part 11, and current MHRA and FDA expectations.
What’s Limiting Sponsor Oversight Across CROs, Vendors, and Study Execution?
Sponsor oversight weakens when study execution, documentation, delegation, monitoring, and quality workflows remain disconnected across systems and vendors.
- Study progress depends on delayed CRO updates and fragmented vendor reporting.
- eTMF records, site documentation, and DoA activity remain disconnected across execution and monitoring workflows.
- Deviations, CAPAs, safety events, delegation updates, and monitoring findings remain tracked across separate systems.
- Risk-based monitoring lacks direct visibility into live site activity, delegation changes, and operational risks.
- Cross-study visibility across regions, sites, vendors, and CRO partners remains fragmented.
- Oversight depends on manual reconciliation across reports, emails, trackers, and disconnected workflows.
Fragmented Systems Break Sponsor Oversight and Increase Trial-Level Risk
Sponsor oversight breaks at the seams. Between the eTMF and the CRO’s CTMS. Between safety signals and CAPA actions. Between what the monitoring report said last quarter and what’s actually happening on site this week. Reconciling those seams is what consumes Quality Director and ClinOps time — and what surfaces as gaps when an inspector asks. AQ replaces seam-level reconciliation with a connected platform for documentation, quality, CAPA, and oversight evidence — built to maintain continuous readiness across CROs, sites, and study activity.
What AQ Changes: Connected Oversight Across Execution, Documentation, and Quality
AQ clinical research platform ensures that study activity, monitoring updates, documentation status, and quality actions are fully aligned within the same system. So, sponsors can easily review progress, assess risk, and track responsibilities without relying on fragmented reports or delayed updates across multiple sources.
eTMF
ensures trial documentation remains structured, complete, and aligned with ongoing study activity so sponsors review document status, approvals, and critical-to-quality factor alignment alongside live execution
QMS
governs policies, SOPs, document control, and quality processes so sponsors maintain consistent quality-by-design oversight of study conduct and organisational compliance across trials
CAPA
tracks deviations, incidents, safety signals, SAE timelines, root cause analysis, and corrective actions so sponsors connect emerging safety trends to site-level conduct, monitor issue resolution, and maintain continuous quality oversight across study execution
eISF
provides visibility into site-level documentation, delegation logs, and training records so sponsors maintain oversight of investigator compliance, site readiness, and structured onboarding across studies
ePSF
connects pharmacy documentation and investigational product accountability with study operations so sponsors maintain oversight of drug handling, storage, and dispensing across sites
DOA
maintains delegation records, role assignments, training acknowledgements, and approval responsibilities within the same operational workflow so sponsors maintain visibility into investigator accountability, site readiness, and responsibility tracking across studies
CTMS
maintains a real-time operational view across study progress, site activity, enrollment, monitoring visits, and milestones so sponsors track execution across CROs and sites without waiting for periodic reports or relying on distributed vendor updates
Solutions Built for Sponsor Oversight Across CROs, Vendors, and Study Lifecycle
Solutions Built for Sponsor Oversight Across CROs, Vendors, and Study Lifecycle
Eliminate Dependency on CRO-Driven Updates
Access live study progress, monitoring activity, site documentation, delegation updates, and operational risks within the same system so monthly CRO governance reviews are not the only window into ongoing study execution.
Keep Documentation Aligned with Study Execution
Ensure eTMF and site documentation reflect real-time activity and critical-to-quality factor status so sponsors review completeness, approvals, and quality alignment without separate reconciliation
Avoid Last-Minute Preparation for Oversight Reviews
Maintain structured, traceable clinical trial study records as work progresses. So the audit and inspection readiness stays continuous rather than reactive across quality, safety, and monitoring activity.
Remove Fragmentation Across Vendors and Systems
Bring CRO, vendor, and site activity into one operational view so performance, timelines, and responsibilities stay visible alongside centralised monitoring risk signals without switching between tools
Reduce Effort Spent on Risk Tracking and Follow-Up
Track deviations, corrective / preventive actions, safety signals, and SAE timelines within the same workflow so safety trends, issue identification, and resolution remain fully connected and consistent across studies
Continuous Inspection Readiness Across Study Activity and Site Records
AQ keeps research environments in a state where records, actions, and timelines remain aligned as work takes place within hospital settings. So, ultimately, research teams rely on current information instead of preparing it later. All while ensuring that inspection and review readiness is maintained through unified study delivery.
Unified Study Visibility
Site milestones, recruitment activity, monitoring status, and overdue actions visible within the same operational view.
Traceable Operational Evidence
Monitoring findings, follow-ups, approvals, protocol deviations, and study decisions connected within the same workflow.
Aligned Study Records
Site documentation, delegation records, monitoring updates, and operational activity aligned within the same study record.
Defined Team Responsibility
Sponsor, CRO, CRA, vendor, and site responsibilities visible across approvals, actions, escalations, and follow-ups.
Request a Live Demo to See How Sponsors Keep Visibility Across Trial Delivery
A live AQ walkthrough shows how sponsors track study progress, site activity, monitoring updates, responsibilities, and quality issues across CROs and research sites without waiting for monthly updates or chasing information across systems.
BOOK A DEMO
Request a Guided AQ Tour
Practical walkthroughs aligned with active research delivery.
We’ll only use your details to arrange your demo and
send relevant AQ updates. No spam.
Here is what our Clients are saying About us
It was a very good experience
This has revolutionised the way we work and improved efficiencies and study compliance reducing admin time spent sending reminders.
– Angie H.
Research Nurse
Both the AQ product and the team were flexible in their approach, they listened to our challenges and were able to embed the AQ platform with ease. The team was trained quickly and we were up and running in no time. The system has enabled us to manage more studies and transformed the way we work.
It was a very good experience
– Fran Westwell
Lead / Senior Research Nurse
It was a very good experience
The AscensionQ platform has helped my research staff set-up multiple studies faster and manage participant appointments more effectively. The software is easy to use and the team is always there to help us.
– Fran Westwell
Lead / Senior Research Nurse
Key Questions Beyond Software Features
How does AQ support clinical trial sponsors and sponsor oversight?
AQ connects trial documentation, operational tracking and quality governance so sponsors maintain continuous, real-time visibility across active programmes. Sites file correctly from activation, deviations carry owners and evidence, and trial documentation stays inspection-ready from startup through database lock, every record structured, attributable and available the moment regulators, monitors or auditors ask.
How does AQ help sponsors maintain oversight under ICH-GCP E6(R3)?
ICH-GCP E6(R3) lets a sponsor delegate the work but never the accountability. AQ gives sponsors a connected view of site documentation, delegation, quality and pharmacy activity without managing each site by hand. Oversight is evidence-based and current, so sponsors can demonstrate control of delegated activity across CROs and sites at any point.
Can sponsors get real-time visibility across sites and CROs?
Yes. AQ gives sponsors one connected record across sites, CROs and countries, with completeness, operational status and quality issues visible continuously. Sponsors see what is complete, what is missing and what needs follow-up across the programme, rather than waiting on portal exports and email updates from each delivery partner.
Is AQ suitable for biotech and first-time sponsors?
Yes. AQ suits biotech and emerging sponsors running early-phase trials without a dedicated quality or operations function. Modules adopt one at a time, so a small team builds a controlled study record from day one and answers diligence, partnering and inspection questions with current evidence, at five people or five hundred.
How does AQ keep sponsor trial documentation inspection-ready for MHRA and FDA?
AQ maintains the eTMF and connected records continuously, with version history, approval evidence, completeness tracking and audit trails designed to support MHRA, FDA, QA and sponsor review. Documentation holds up under scrutiny on demand because it is current by default, not assembled before a visit. Findings link to CAPA with study context attached.
