Frequently asked questions
Will our organisation retain ownership of its data?
Yes. Your organisation retains ownership and control of its research data. AGC DATA only accesses or processes information where necessary to provide the agreed services. Data access, confidentiality and processing responsibilities are documented as part of the project agreement, and a mutual non-disclosure agreement can be put in place before detailed study information is shared.
Can AGC DATA support GDPR and HIPAA requirements?
Yes. Systems can be designed and configured to support applicable data-protection and information-security requirements, including UK GDPR, EU GDPR and HIPAA-related controls where required.
The specific approach will depend on the study, participating organisations, hosting arrangements, system providers and allocation of responsibilities. Relevant controls may include regional hosting, role-based permissions, multi-factor authentication, audit trails, controlled integrations and documented data-processing arrangements.
Who does AGC DATA work with?
We work with clinical research teams across a range of roles, including principal investigators, trial managers, data managers, pharmacists, research nurses, laboratory teams, statisticians, analysts and information-governance professionals.
Whether you are planning a new study, improving an existing database or resolving problems within an active project, AGC DATA can provide practical support.
What does the AGC DATA development process involve?
Our process is flexible and can include one or more of the following stages:
Discovery and consultation – We discuss your study, existing systems and operational requirements.
Database development – We design, configure, test and document an electronic data capture system tailored to your protocol.
CRISPNet integration – For CTIMPs, we can integrate IMP-management workflows covering allocation, accountability, dosing, inventory monitoring and emergency unblinding.
Is the discovery call really free?
Yes. The initial call gives you an opportunity to discuss your project, ask questions and receive an honest assessment of the most appropriate next steps.
Where AGC DATA is a suitable fit, we will outline a potential approach. There is no pressure or obligation to continue.
What does AGC DATA do?
AGC DATA designs and supports data systems for clinical research.
Our services include electronic data capture, REDCap database development, workflow automation, participant and sample tracking, reporting tools and specialist IMP-management infrastructure for CTIMPs.
From early study planning to close-out, we make research data easier to collect, manage and trust.
Case Studies
Practical examples of how AGC DATA has translated complex research requirements into reliable data systems.
MAC-Endo CTIMP Database and IMP Management
Client: Professor Andrew Horne, University of Edinburgh
Study: Phase II, single-centre, double-blind, placebo-controlled CTIMP evaluating three escalating doses of an investigational medicinal product for endometriosis-associated pain.
Key deliverables:
REDCap clinical trial database
CRISPNet IMP-management integration
Pharmacy dispensing interface
Secure emergency-unblinding workflow
Automated data-quality monitoring
IMP accountability and inventory tracking
The challenge
The study required a secure and traceable system that could:
Conduct block randomisation while maintaining the study blind
Link each allocation to a complete IMP accountability record
Provide pharmacy teams with clear dispensing instructions
Support secure emergency unblinding at any time
Track IMP stock, expiry, dispensing, returns and destruction
Integrate clinical, questionnaire, sample and pharmacy data
The solution
A study-specific REDCap architecture was developed before first-participant enrolment and integrated with CRISPNet to automate key IMP-management processes.
The system included:
Randomisation and allocation
CRISPNet managed block randomisation and recorded blinded treatment allocations within the relevant REDCap accountability records.
Pharmacy dispensing workflow
Role-restricted interfaces provided pharmacy staff with the information required to select and dispense the correct IMP pack.
Emergency unblinding
A secure, audit-logged workflow allowed authorised medical personnel to access treatment information where clinically necessary without exposing the allocation to the wider study team.
Inventory management
The system tracked IMP stock, expiry dates, dispensing, returns and destruction, with automated notifications when stock required attention.
Integrated study oversight
Clinical, IMP, sample and questionnaire information was managed across a connected REDCap framework, reducing reliance on separate spreadsheets and manual reconciliation.
The impact
The completed system brought participant enrolment, IMP management, sample tracking and questionnaire data into a connected research infrastructure.
Automated accountability records, stock monitoring and restricted unblinding workflows reduced repetitive administrative steps and strengthened traceability. The use of REDCap and a study-specific CRISPNet integration also provided a cost-effective alternative to a large commercial clinical trial platform.
Future-Proofing Reproductive Research Data
Client: Professor Hilary Critchley and Dr Jacqueline Maybin, University of Edinburgh
Scope: Six observational studies containing overlapping variables and shared biological samples.
Key deliverables:
Harmonised REDCap data framework
End-to-end biological sample-tracking system
Shared variable structure
Cross-study reporting tools
User guidance and supporting documentation
The challenge
Six related studies were operating across separate databases, data dictionaries and supporting spreadsheets.
Differences in variable structures and sample-recording processes made it difficult to:
Compare data across studies
Locate available biological samples
Review sample use and depletion
Identify potentially duplicated assays
Produce consistent portfolio-level reports
Reuse data structures for future projects
The solution
A common set of core variables was identified and mapped across the studies. Modular extensions were then developed to accommodate project-specific requirements without losing consistency between databases.
Six linked REDCap projects were configured to feed into a shared reporting framework.
An end-to-end sample-management system was also developed to record each sample through:
Collection
Receipt
Processing
Aliquoting
Storage
Assay use
Transfer
Depletion
Supporting guidance and quick-start materials were provided to help laboratory and data teams adopt the new processes without disrupting active recruitment.
The impact
The studies now operate within a more consistent and expandable research-data framework.
Researchers can locate samples more efficiently, review their availability and use, identify potential duplicate activity and prepare cross-study datasets without rebuilding the underlying structure for every analysis.
The framework can also be extended as new studies, variables and sample collections are introduced.
Discuss your project
Whether you are developing a new study, reviewing an existing database or trying to improve a difficult research workflow, contact AGC DATA to discuss how we may be able to help.