A Clinical Research Delivery Centre (CRDC) creates a coordinated research network where multiple NHS sites deliver clinical trials under shared governance, oversight, and quality standards aligned with MHRA, ICH-GCP E6(R3), and UK Clinical Trials Regulations.

This guide explains how CRDCs operate, why multi-site research oversight demands connected control across every participating site, and how AQ supports research networks with unified documentation, quality governance, and operational visibility from hub to spoke.

What you will understand through AQ’s Guide to CRDCs and Multi-Site Research:

• What a CRDC is and how it operates within the NHS research infrastructure
• How the hub-and-spoke model distributes research delivery and oversight responsibility
• What multi-site research demands in terms of documentation, governance, and operational control
• Why fragmented systems create governance gaps in a network with multiple active sites
• What inspection-ready multi-site oversight looks like across a CRDC
• How eISF, ePSF, CAPA, CTMS, and Digital DoA function together in a multi-site environment
• What challenges arise when oversight operates without a connected research platform
• How AQ supports CRDC research networks with connected operational control from hub to spoke
• What role-based visibility means for hub leads, site coordinators, quality teams, and pharmacy staff
• How to approach platform adoption across an expanding research network
• What regulatory foundations underpin connected multi-site research oversight

What is a Clinical Research Delivery Centre (CRDC)?

A Clinical Research Delivery Centre (CRDC) is a collaborative NHS research infrastructure that coordinates the delivery of clinical trials across a defined network of participating hospitals, trusts, and specialist research sites. CRDCs bring multiple institutions together under a shared governance framework, enabling studies to recruit participants and collect data across several sites while maintaining consistent standards, coordinated oversight, and unified accountability.

Within the NHS, CRDCs operate as regional research hubs. Each CRDC designates a lead host institution — typically a large teaching hospital or NHS trust — that anchors the operational and governance infrastructure for the network. Partner sites across the region participate in active studies, recruit participants, manage site-level research activity, and report into the shared governance structure the hub maintains.

The CRDC model serves several interconnected purposes. It expands patient access to clinical trials across a region, enabling studies to recruit at scale without replicating infrastructure at every site. It centralises quality oversight, document governance, and sponsor engagement across participating sites. It reduces duplication by allowing shared protocols, shared document templates, and shared governance processes to operate across the network. It also supports the NHS Long Term Plan objective to increase the reach of research activity across the health system.

CRDCs operate under MHRA regulatory oversight and are aligned with ICH-GCP E6(R3), UK Clinical Trials Regulations (as updated April 2026), NHS Research Governance Framework expectations, and Health Research Authority (HRA) requirements. Each participating site retains its own research governance responsibilities while operating within the shared framework the CRDC establishes and the hub maintains.

How CRDCs Operate: The Hub-and-Spoke Model

CRDCs function through a hub-and-spoke operational model. The hub — the lead NHS trust — provides central governance, manages authoritative document versions, coordinates quality activity, and maintains network-wide oversight. Spoke sites — participating hospitals, trusts, and specialist centres — conduct research activity locally, manage participant-facing operations, and report into the central governance structure.

This model creates a clear operational division. Hub teams are accountable for network governance standards, document distribution, quality assurance, and sponsor engagement. Spoke teams are accountable for local execution, site-level documentation, participant safety, and compliance with the standards the hub sets. The relationship is not hierarchical in a management sense, but it is structured in an accountability sense: the hub cannot discharge its governance responsibility unless it has current, reliable visibility of what is happening at every spoke.

Responsibility Area	Hub Role	Spoke Role
Network governance	Sets standards, frameworks, and quality expectations across the CRDC	Operates within defined governance standards and reports activity to the hub
Document management	Manages authoritative document versions, amendment distribution, and approvals	Receives, acknowledges, and files site-specific documents within the local ISF
Quality oversight	Reviews quality activity, CAPA resolution status, and network-wide risk	Logs deviations, raises quality issues, and completes corrective actions at site level
Pharmacy control	Coordinates investigational product accountability and distribution across the network	Manages local IP handling, dispensing records, storage oversight, and accountability
Delegation governance	Defines delegation expectations and approves delegation records across the network	Maintains current delegation records, role assignments, and active authorisations at site
Sponsor engagement	Manages sponsor oversight, monitoring coordination, and programme-level reporting	Participates in monitoring visits and provides site-level documentation and evidence
Inspection readiness	Maintains network-wide readiness overview and coordinates response	Maintains site-level documentation completeness and current audit evidence

The hub-and-spoke model enables research at scale. It also concentrates oversight risk at the hub. If the hub cannot see current document status, open quality issues, delegation gaps, or pharmacy accountability across spokes in real time, it cannot exercise the governance oversight it is accountable for.

Also Read: What is eISF in Clinical Research?

Why Multi-Site Oversight is Required in CRDC Research

Multi-site research introduces operational complexity that single-site governance frameworks were not designed to manage. Studies run simultaneously across sites with different teams, different levels of research maturity, different document filing practices, and different quality histories. The hub must maintain governance accountability across all of this while coordinating sponsor engagement, monitoring activity, and inspection readiness without duplicating effort across every site.

Multi-site oversight is required because:

• Each site maintains its own investigator site file, delegation records, and pharmacy documentation that the hub must be able to review and confirm
• Document versions, amendments, and approvals must remain consistent across all participating sites, with each site operating from the same current version at all times
• Delegation of authority records must reflect active roles and assigned responsibilities at every site, not just at the time of the last monitoring visit
• Quality events at one site may have implications for practice across the entire network and must be visible to hub quality teams in real time
• CAPAs raised at site level require hub visibility, coordinated investigation, and tracked follow-through that a monitoring visit cannot provide alone
• Sponsor oversight and monitoring activity spans multiple sites with different readiness levels, and sponsors require current evidence not reconstructed records
• Regulatory inspection can occur at the hub or any spoke site at any time, and inspection readiness cannot be rebuilt at short notice from fragmented filing systems
• Training, competency, and acknowledgement requirements must be tracked across distributed teams to confirm that staff operated under current procedures at the time of each activity
• Pharmacy documentation and investigational product accountability must remain controlled and evidenced across each site throughout the study lifecycle
• A missing document at a spoke site is a hub accountability issue; an unresolved CAPA at one site is a pattern risk across the network

Core Oversight Functions Across a Multi-Site CRDC Research Network

Oversight Function	What It Controls	Consequence Without It
eISF (Electronic Investigator Site File)	Site-level document completeness, version control, signature workflows, filing structure, and audit-ready document history at each participating site	Sites operate with incomplete or out-of-version documents; the hub cannot confirm compliance without requesting manual file reviews from each site team
ePSF (Electronic Pharmacy Site File)	Pharmacy documentation, IP accountability records, dispensing logs, storage oversight, and pharmacy authorisations at each site within the same research environment	Pharmacy activity cannot be evidenced or audited; IP accountability gaps create regulatory exposure across the network
CAPA Management	Deviation records, investigation workflows, corrective and preventive actions, root cause analysis, closure evidence, and effectiveness verification across all sites	Quality issues remain unresolved or incompletely evidenced; recurring issues across sites cannot be detected, investigated, or addressed systematically
CTMS (Clinical Trial Management System)	Study execution, participant enrolment, visit schedules, operational milestones, site activity tracking, and coordinated task management	Operational progress across sites cannot be tracked; visit deviations and operational gaps are not visible to the hub until after a monitoring visit
Digital Delegation of Authority (DoA)	Role assignments, delegated responsibilities, effective dates, authorisation evidence, and delegation history at each participating site	Sites operate without current and verified authority records; delegation gaps create accountability risk and are difficult to evidence at inspection
QMS (Quality Management System)	Controlled documents, SOP governance, training requirements, staff acknowledgements, competency validation, and quality activity oversight across the network	Quality standards are not consistently applied; training gaps and SOP deviations remain undetected until a monitoring finding or inspection observation surfaces them
Cross-Site Oversight Dashboard	Hub-level visibility of documentation readiness, quality risk, open actions, milestone status, and site-level progress across all participating sites	The hub cannot exercise real-time governance oversight without manually collecting, reconciling, and interpreting records from each site in separate systems

What is Inspection Readiness in a Multi-Site CRDC Network?

Inspection readiness in a multi-site CRDC network means that the hub and every participating site can produce complete, accurate, and current evidence of research activity at any point in the study lifecycle — without requiring emergency preparation, manual record reconstruction, or review requests sent to individual sites.

Achieving this condition requires more than complete filing at each site. It requires a connected operating layer where documentation, delegation, quality activity, and pharmacy accountability remain visible across the network as research progresses. Inspection-ready multi-site research operations depend on:

• Current and complete investigator site files at every participating site, maintained through controlled filing and milestone-driven document management
• Authoritative document versions with distribution records confirming which version each site acknowledged and when
• Pharmacy documentation with traceable IP accountability at each site, integrated with the investigator site record
• Current delegation records reflecting active roles, assigned responsibilities, and effective dates at every site
• Resolved or actively managed quality events with structured investigation, documented corrective and preventive actions, and verifiable closure evidence
• Training records confirming that staff operated under current approved procedures at the time of each research activity
• Visit and milestone records linked to the protocol version in effect at the time
• Audit trails capturing every system action with user identity, timestamp, and context across all modules

Inspection readiness is not an event that a research team prepares for. It is the condition that exists when research operations are under consistent, continuous control. Achieving it before a monitoring visit or regulatory inspection by reconstructing scattered records represents a failure of operational governance, not a valid preparation strategy.

Also Read: What is CAPA Management Software in Clinical Research?

Common Challenges Without a Connected Research Platform

• Hub teams cannot confirm document status across sites without requesting file reviews from each site team, which delays oversight and increases administrative burden
• Out-of-version documents continue in use at spoke sites while the hub distributes updated versions through email and shared drives with no confirmation of acknowledgement
• No single view of CAPA status across the network means open quality issues are tracked in separate spreadsheets managed by different teams at different sites
• Delegation records at spoke sites are maintained locally and are not visible to hub governance teams until a monitoring visit surfaces a gap or inconsistency
• Pharmacy documentation exists in separate local files and is not integrated with investigator site records, making cross-referencing during a monitoring visit labour-intensive
• Training completion cannot be confirmed across distributed teams without manual tracking systems that depend on site staff updating records consistently
• Site-level inspection readiness varies significantly across the network and is only visible to the hub when a monitoring visit or regulatory inspection surfaces the gap
• Protocol amendments and consent form updates distributed through email create version risk when sites acknowledge and file documents on different timelines
• Study progress at spoke sites cannot be viewed by hub operational leads without requesting status reports from each site coordinator
• Quality events at one site are not visible to the hub quality team until they are manually escalated, delaying coordinated response
• CAPA closure evidence is scattered across site files and email threads rather than structured within one traceable, auditable system
• Hub-level sponsors and monitors cannot review current study documentation without visiting each site or requesting document packages from site teams

Also Read: What is ePSF in Clinical Trial Data Management?

Key Benefits of Connected Oversight for CRDC Research Networks

A connected research platform gives hub teams, quality leads, site coordinators, and pharmacy staff a shared operational environment where documentation, delegation, quality governance, and study execution remain visible, traceable, and current across every participating site. Here are the principal benefits:

Real-Time Hub Visibility Across All Sites

Multi-site research governance requires the hub to maintain current awareness of documentation completeness, open quality actions, delegation status, and study progress across all participating sites. A connected research platform surfaces this information without requiring the hub to request updates from individual site teams.

For example, if you are a Hub Governance Lead responsible for oversight of a CRDC study running across ten sites, you need to understand which sites have complete and current investigator site files, which sites have open CAPA actions, and where document gaps exist before the next sponsor monitoring visit. Without a connected platform, you contact each site coordinator separately, wait for responses, and reconcile information manually. With AQ, a single cross-site dashboard displays document readiness by site, overdue milestone status, open CAPA actions by stage, and delegation completeness — updated in real time as site teams complete their work.

Controlled Document Distribution and Version Management

Protocol amendments, updated consent forms, and new SOPs must reach every participating site in a current, acknowledged version. Without structured distribution and acknowledgement controls, version risk accumulates across the network as sites operate on different iterations of the same document.

For example, if you are a Research Governance Manager issuing a protocol amendment that changes visit windows across a CRDC study, you need to confirm that every site received the updated protocol, acknowledged it within the required timeframe, and filed it correctly within their investigator site file. Without version control and acknowledgement tracking, you rely on individual emails from each site. With AQ eISF, document distribution triggers per-site acknowledgement requirements, and the hub can view acknowledgement status across all sites within the same dashboard used for day-to-day oversight.

Connected Quality and CAPA Governance Across the Network

Deviations and quality events that occur at spoke sites have implications for hub accountability and, where patterns emerge, for the whole network. CAPA processes that run in site-local spreadsheets cannot give the hub the visibility it needs to understand whether quality issues are being resolved, whether corrective actions are proportionate, and whether preventive measures are being applied across sites where the same risk exists.

For example, if you are a Quality Lead at the hub and a deviation is raised at a spoke site related to an out-of-version consent form, you need to confirm that the CAPA has been correctly initiated, that root cause analysis has been completed, and that the corrective action will prevent the same issue at other sites. With AQ CAPA, the hub can view the deviation record, the investigation status, the assigned corrective actions, and the effectiveness verification outcome without requesting updates from the site team. If the same pattern appears at another site, the quality lead can cross-reference CAPA records across the network.

Pharmacy Documentation Within the Same Research Environment

Investigational product accountability is a regulatory requirement under UK Clinical Trials Regulations and MHRA GCP expectations. Pharmacy documentation that lives in separate local files — disconnected from the investigator site file and the hub’s governance view — cannot be confirmed, cross-referenced, or evidenced without manual collection from each site.

For example, if you are a Sponsor Monitor preparing for a monitoring visit across three CRDC sites, you need to confirm that IP accountability records are complete, that dispensing logs match reconciled totals, and that pharmacy authorisations are current at each site. With AQ ePSF, pharmacy documentation exists within the same research environment as the investigator site file. The hub can see pharmacy readiness alongside document readiness within one oversight view, and the monitor can review pharmacy records without coordinating separate access to local pharmacy filing systems.

Inspection Readiness as a Continuous Operational Condition

Inspection readiness in a multi-site CRDC network cannot be achieved through periodic review cycles. A regulatory inspection can occur at any site, at any time, and the condition of that site’s documentation and governance records at that moment is what the inspection will assess. Research networks that rely on pre-inspection preparation are operationally exposed throughout the rest of the year.

For example, if you are a CRDC Research Director and MHRA notifies a monitoring visit to one of your spoke sites with five working days’ notice, you need to confirm that the site’s investigator site file is complete, delegation records are current, pharmacy accountability is traceable, and any open CAPAs have documented investigation and resolution evidence. With a connected platform, the hub governance lead opens the cross-site readiness dashboard, reviews the site’s compliance status in real time, identifies any outstanding gaps, and coordinates resolution within the available window — without requesting a document audit from the site team.

Also Read: What is Clinical Research Software and How to Choose the Right One?

How Connected Multi-Site Oversight Works: A CRDC Operating Scenario

Consider a CRDC running a Phase II study across eight participating sites, with the lead NHS trust acting as hub and seven spoke sites recruiting participants and managing local research activity. The study is midway through recruitment, a protocol amendment has just been approved, and an MHRA monitoring visit has been scheduled for one of the spoke sites in three weeks.

Amendment distribution and version control

The hub governance team uploads the approved protocol amendment and updated patient information sheet to the AQ eISF study binder. The system applies version control automatically, assigns the updated documents to the relevant folder within each site’s binder, and generates acknowledgement requirements for each site. The hub dashboard displays acknowledgement status across all eight sites in real time, flagging which sites have confirmed receipt and which have outstanding acknowledgements.

Site coordinators at each spoke receive task notifications through the platform. Each coordinator reviews the updated documents, acknowledges receipt within their site binder, and uploads the locally-signed version where required. The hub can see acknowledgement progress without contacting any site directly.

Document gap and CAPA from a filing issue

The cross-site readiness dashboard flags that one spoke site has an overdue document placeholder for the updated informed consent form. The site coordinator receives an automated overdue alert. The hub quality lead reviews the flag and identifies that the site’s consent form version predates the protocol amendment, meaning participants may have been consented using an earlier version of the form.

The quality lead raises a CAPA directly from the document record within AQ eISF. The system creates a structured CAPA record linked to the document issue, assigns the investigation to the site quality lead, and records the source type as Deviation. The investigation confirms that three participants were consented using the superseded form. Root cause analysis identifies a gap in the site team’s document acknowledgement process. Corrective actions are assigned, given due dates, and tracked within the CAPA workflow until each task is marked complete by the responsible staff member. The hub quality lead reviews effectiveness verification once all actions are closed, confirms the CAPA as effective, and the record is formally closed with full audit trail evidence.

Monitoring visit preparation

Three weeks before the MHRA monitoring visit, the hub governance lead opens the site comparison view in the AQ eISF dashboard. The view displays document completeness, signature readiness, overdue placeholders, and CAPA status for the site being visited alongside all other network sites for reference.

The hub confirms that the site’s investigator site file is 94% complete, that all outstanding placeholders are within the resolution window, and that the consent form CAPA has been closed with verified effectiveness. Delegation records are reviewed through the Digital DoA module, confirming that current role assignments match the study protocol requirements. Pharmacy accountability records in the ePSF are complete, with all dispensing logs reconciled and storage records current.

The monitor reviews the site’s documentation directly through the platform prior to the visit, confirms outstanding items with the site team, and arrives at the monitoring visit with a current view of the site’s compliance status. The visit proceeds without emergency preparation because the governance records have been maintained continuously, not reconstructed.

So now it must be clear how connected multi-site oversight ensures that a CRDC research network operates within a controlled environment where:

• Document completeness and version currency are enforced through structured filing and milestone-driven acknowledgement controls
• Quality issues are identified, investigated, and resolved within a traceable workflow before they accumulate into inspection risk
• Hub governance teams maintain current awareness of every site’s readiness without requiring manual outreach to site teams
• Inspection evidence exists continuously as a function of daily research operations, not as the product of last-minute preparation

Also Read: What is QMS in Clinical Research?

Types of Research Documentation Approaches in Multi-Site Environments

Research networks operate with different levels of documentation maturity. The approach in use directly affects how well hub teams maintain oversight, how consistently sites manage their records, and how much effort audit and inspection preparation requires. Understanding the differences across common approaches helps determine operational risk exposure across a multi-site network.

Approach	How It Works	Multi-Site Oversight Impact	Inspection Readiness Risk
Paper-Based ISF	Physical folders at each site, manually maintained by site teams with paper audit trails	Hub has no real-time visibility; each site visit requires physical review of local files	High: records cannot be confirmed without visiting each site; reconstruction is time-intensive
Shared Drives and Email	Digital documents stored in folder structures on shared drives, distributed and acknowledged by email	No version enforcement; acknowledgement depends on manual email tracking; hub cannot confirm status	High: version currency cannot be confirmed; acknowledgement records are not structured or auditable
Standalone eISF (per site)	Electronic ISF system used at individual sites without hub connection or cross-site visibility	Each site maintains its own electronic record; hub must log in to multiple systems or request reports	Medium: documentation is structured at site level but hub visibility remains fragmented
Connected Research Platform (AQ)	Unified environment where eISF, ePSF, CAPA, CTMS, and DoA operate across all sites within one connected system	Hub has real-time cross-site visibility; sites work locally while the hub sees current status across the network	Low: inspection readiness is a continuous operational condition, not an emergency preparation task

AQ for CRDCs: One Inspection-Ready Operating Layer Across the Network

AQ provides a connected research operating environment where eISF, ePSF, CAPA, CTMS, Digital DoA, and QMS operate within one platform across every participating site. Hub teams maintain real-time governance visibility. Spoke site teams work within role-based views that surface their active tasks, overdue requirements, and pending approvals without navigating multiple systems.

AQ functions as the operational control layer for the CRDC by connecting:

• eISF across all sites — per-site binders with milestone-driven document requirements, controlled filing, version tracking, signature workflows, and a cross-site readiness dashboard that displays completeness, overdue items, and signature status for every participating site
• ePSF within the same research environment — pharmacy documentation, IP accountability records, dispensing logs, and storage oversight at each site, visible to hub teams alongside investigator site file records
• CAPA from any document issue, deviation, or quality event — structured investigation, root cause analysis, corrective and preventive action workflows, effectiveness verification, and full audit trail evidence, accessible to hub quality teams across all sites
• CTMS for operational visibility — study execution, participant enrolment, visit schedules, milestones, and site-level task management connected to the same operational record as documentation and quality activity
• Digital DoA for delegation governance — role assignments, effective dates, authorisation evidence, and delegation history at each site, maintained within a controlled record and visible to hub governance teams
• QMS for quality governance — controlled SOPs, training requirements, staff acknowledgements, competency validation, and audit activity, structured within one quality layer aligned with daily research operations

AQ also provides continuous AI-assisted readiness monitoring, surfacing documentation gaps, overdue actions, and quality signals across the network before they accumulate into inspection risk. Document intelligence highlights missing files and supports faster record retrieval across multi-site study binders. Workflow assistance guides site staff through task completion, reducing the dependence on manual coordination from hub teams.

Role-based visibility across the CRDC network

AQ gives each role a purposeful view of the study without requiring access to records that are not relevant to their responsibilities.

Role	What AQ Provides
CRDC Hub Governance Lead	Cross-site readiness dashboard showing document completeness, overdue milestones, signature status, CAPA activity, and delegation records across all participating sites in real time
Research Coordinator (Spoke)	Site-specific task list showing required document uploads, overdue placeholders, pending acknowledgements, and signature requirements without accessing other sites’ records
Research Matron / Delivery Lead	Readiness view for their site’s active studies, delegation records, training completion status, and open quality actions without navigating separate quality systems
Quality Lead (Hub or Site)	CAPA dashboard showing open deviations, investigation status, action completion, and effectiveness verification across all sites, with the ability to raise CAPAs directly from document records
Pharmacy Staff	ePSF view for IP accountability, dispensing records, storage oversight, and pharmacy authorisations within the same environment as the investigator site file
Sponsor Monitor / CRA	Remote access to current study documentation across sites, with audit trail visibility, document version history, and CAPA status available without requesting site-specific report packages

Key Features to Look for in a Multi-Site Research Platform

• Multi-site eISF with per-site binders, controlled document templates, milestone-driven filing requirements, and a cross-site readiness dashboard visible to hub teams
• Version control and acknowledgement tracking that confirms which document version each site received, acknowledged, and filed — without relying on email confirmations
• ePSF integrated within the same research environment as the investigator site file, with IP accountability, dispensing records, and pharmacy authorisations accessible to hub governance teams
• CAPA management with structured investigation, root cause analysis, corrective and preventive action workflows, effectiveness verification, and full audit trail evidence linked to the triggering document or event
• Digital Delegation of Authority with current role assignments, effective dates, authorisation evidence, and delegation history at each site, visible to hub governance teams
• Cross-site readiness dashboard showing document completeness, signature status, overdue milestones, CAPA activity, and site readiness scores across all participating sites
• Role-based access control ensuring that site staff see their own site’s records and hub teams see the network-wide view, without exposing records across sites inappropriately
• Audit trail controls capturing every system action with user identity, timestamp, document version, and context across all modules and all sites
• Secure electronic signatures aligned with 21 CFR Part 11 and UK eIDAS, with re-authentication required for significant actions including document signing, locking, and CAPA lifecycle transitions
• CTMS with operational visibility across study execution, visit schedules, milestones, and participant activity connected to the same record as documentation and quality events
• Configurable templates and milestone plans that allow the hub to define document requirements once and apply them across all participating sites
• Scalable commercial model that treats the CRDC network as a single operational unit rather than charging per site or per study
• NHS-aligned security and compliance foundations including NHS DSPT alignment, ISO 27001-aligned controls, ICO registration, Cyber Essentials, and GxP computerised system validation
• Phased onboarding that allows the network to go live with priority modules first and expand without enterprise-scale implementation programmes

How to Deploy a Connected Research Platform Across a CRDC Network

Deploying a connected research platform across a CRDC requires a structured approach that respects the operational pressures of active sites, the governance requirements of the hub, and the different levels of digital maturity across a distributed network. The goal is to introduce consistent operational control without disrupting ongoing research activity or requiring all sites to move at the same pace.

1. Confirm priority use cases and success measures with hub and site leads. Identify which oversight gaps create the most risk — commonly: document version control, cross-site readiness visibility, CAPA tracking, and delegation governance.
2. Complete a technical, security, and governance evidence review. Confirm the platform’s NHS DSPT alignment, validation documentation, ICH-GCP mapping, ALCOA+ controls, and information governance pack before procurement decisions are made.
3. Run an operating-model workshop with hub governance leads and site representatives. Map current workflows, identify manual reconciliation points, and define what success looks like for each role across the network.
4. Configure the hub-and-spoke structure. Set up the hub as the central oversight environment, create per-site binders within the multi-site eISF, assign role-based access for each site team, and configure study templates and milestone plans.
5. Introduce priority modules first. For most CRDCs, the first deployment covers eISF 2.0 across all sites and CAPA management at the hub level. ePSF, CTMS, Digital DoA, and QMS can follow in the order that matches operational priority.
6. Run the platform in parallel with existing workflows during the go-live period. Active studies continue in existing systems while teams build familiarity with AQ, reducing disruption to ongoing research activity.
7. Train teams based on their role, not on the full platform. Site coordinators need the site binder view, task management, and document upload workflows. Hub governance teams need the cross-site dashboard, CAPA overview, and version control processes.
8. Migrate active study records into the platform in controlled stages. Current documents and active quality actions take priority. Archived or historical records can be migrated later without affecting operational continuity.
9. Enable the hub oversight dashboard from day one. Cross-site readiness, overdue alerts, and CAPA status should be visible to hub governance teams as soon as sites begin using the platform, establishing the governance value immediately.
10. Refine and expand. Once core oversight is stable, extend coverage to additional modules, onboard additional sites, and develop the shared roadmap items aligned to the network’s evolving operating model.

eISF, ePSF, CTMS, CAPA, and Digital DoA in Multi-Site Research

Aspect	eISF	ePSF	CTMS	CAPA	Digital DoA
Core Purpose	Controls site document completeness, filing, version history, and signatures	Controls pharmacy documentation, IP accountability, and dispensing records	Controls study execution, participant activity, visit schedules, and milestones	Controls investigation, corrective action, preventive action, and closure evidence	Controls delegation records, role assignments, effective dates, and authorisation evidence
Primary Users	Site coordinators, hub governance, monitors, investigators	Pharmacy staff, hub governance, monitors	Coordinators, investigators, hub operational leads	Quality leads, investigators, hub governance	Investigators, site managers, hub governance
Multi-Site Value	Hub sees readiness, overdue items, and version status across all sites	Pharmacy records are visible alongside ISF records within one hub view	Operational progress across all sites is visible from one hub dashboard	CAPA activity across all sites is managed and visible from the hub quality view	Delegation currency is confirmed across every site without requesting paper files
Inspection Risk Without It	Hub cannot confirm document currency or completeness without manual site reviews	Pharmacy accountability gaps create regulatory exposure; evidence is not accessible remotely	Operational gaps and visit deviations are not visible until after a monitoring visit	Quality issues accumulate unresolved; patterns across sites cannot be detected	Delegation gaps are not visible until an inspection surfaces missing or expired records

Explore AQ for CRDCs and Multi-Site Research Networks

AQ is an independently accessible module platform within a connected end-to-end clinical research environment, designed to give CRDCs and multi-site research networks the operational control, documentation governance, and quality oversight they need across every participating site.

AQ brings together:

• eISF 2.0 with multi-site binder management, cross-site readiness dashboard, milestone-driven document requirements, and controlled electronic signatures
• ePSF for pharmacy documentation and IP accountability within the same inspection-ready environment as the investigator site file
• CAPA management with structured eight-stage lifecycle, root cause analysis, corrective and preventive action workflows, effectiveness verification, and full audit trail evidence
• CTMS for end-to-end operational visibility across study execution, participant activity, and site-level milestones
• Digital DoA for controlled delegation governance with current role assignments, effective dates, and traceable authorisation history at each site
• QMS for connected quality governance with controlled documents, training management, staff compliance tracking, and audit-ready records

AQ is built around over 20 years of clinical research operations experience and is aligned with ICH-GCP E6(R3), UK Clinical Trials Regulations, MHRA inspection expectations, ALCOA+, 21 CFR Part 11, UK GDPR, Data Protection Act 2018, NHS DSPT, GxP computerised system validation, and GAMP 5. The platform supports modular deployment, allowing CRDCs to start with priority capabilities and expand progressively across connected workflows without enterprise-scale implementation programmes.

AQ supports organisations operating across paper files, shared drives, legacy tools, and existing electronic systems. Research networks establish consistent oversight while transitioning toward a structured, inspection-ready research operating model at a pace that works for the network.

Request a Live AQ Platform Demonstration. Speak with our team to explore how AQ supports CRDC and multi-site research operations through a live walkthrough of hub-and-spoke oversight, eISF, ePSF, and CAPA management.