A hybrid eConsent approach overcame regulatory and logistical challenges in a Swiss pediatric ophthalmology study, ensuring compliance and accelerating patient enrollment.
When informed consent becomes a logistical challenge
Obtaining informed consent is one of the most critical steps in any clinical trial.
In pediatric studies, obtaining informed consent is more complex as researchers must ensure regulatory compliance and protect the rights and well-being of minors and their families.
A Swiss pharmaceutical company preparing a multinational pediatric ophthalmology study faced this challenge. Because children were involved, both parental consent and participant assent were required.
The sponsor requests
The Sponsor required consent from both parents when possible, which, while ethical, posed practical challenges.
Many families have separated parents, live in different locations, or have conflicting schedules, making joint site visits difficult.
Paper-based signatures risked enrollment delays, extra paperwork, and protocol deviations. The Sponsor needed a solution balancing compliance, flexibility, and family experience.
This is where ACTide eConsent provided a practical and compliant answer.
The clinical and regulatory context of pediatric informed consent
Pediatric clinical research is subject to stricter ethical requirements than adult studies.
International rules require consent from legal representatives and age-appropriate involvement of the child.
- FDA guidance stresses proper documentation and clear, understandable consent processes.
- European regulators also stress patient protection and efficient trial conduct.
For pediatric studies, these requirements often create additional operational complexity.
Common challenges
When consent collection depends entirely on paper workflows, these factors can slow patient enrollment and place additional pressure on site staff already managing demanding study procedures.
The challenges may include:
- parents living separately.
- Different availability schedules.
- Geographic distance from the study site.
- Delays in returning signed documentation.
- Increased risk of incomplete consent records.
The solution: ACTide Hybrid eConsent
Nubilaria worked with the Sponsor to design a compliant, practical consent process.
The project used ACTide eConsent’s flexibility to let sites choose digital or paper consent as needed, and enabled:
- remote signatures were available for parents who could not attend the site.
- Sites used traditional paper consent when required by local procedures or specific circumstances.
- All consent activities remained fully traceable throughout the process.
The goal is to let families choose the best consent pathway while ensuring full regulatory oversight.
ACTide eConsent handled multiple scenarios, helping sites manage complex family situations efficiently and preserve data integrity.
Ready to enhance your informed consent process? See how ACTide eConsent supports participant-centric workflows below.
Maintaining compliance while improving flexibility
Introducing digital consent raises concerns about regulatory compliance.
The solution implemented by Nubilaria was designed to support industry expectations regarding electronic records and signatures, including:
- FDA 21 CFR Part 11 requirements.
- EU Annex 11 principles.
- Audit trail management.
- User authentication controls.
- Complete consent documentation traceability.
The advantages
This kept every consent record verifiable, secure, and inspection-ready.
Families benefited from a more accessible process with less travel and easier scheduling, that supported both operational efficiency and regulatory rigor.
Because ACTide eConsent is part of ACTide, consent info can be integrated with eCRF data, reducing duplication and improving oversight.
Results and key takeaways
The hybrid eConsent strategy delivered tangible benefits for both the Sponsor and participating sites. Key outcomes included:
Faster patient onboarding
Families were able to complete consent procedures more efficiently, reducing delays associated with coordinating multiple signatures.
Improved operational flexibility
Sites could adapt the consent process to real-world family circumstances without compromising compliance.
Strong regulatory confidence
The Sponsor maintained complete oversight of consent documentation while meeting applicable regulatory expectations.
Better participant experience
Parents and young participants encountered fewer logistical barriers during enrollment.
Zero compliance gaps
Despite the complexity of obtaining signatures from multiple legal representatives, the process remained fully documented and auditable.
The reason why hybrid eConsent is becoming increasingly important
Clinical trials are becoming more decentralized, global, and patient-centric.
At the same time, regulators continue to emphasize participant protection, transparency, and data integrity.
Sponsors and CROs now need consent solutions that match real-world participant situations, not rigid processes.
Hybrid eConsent models offer a practical middle ground
Hybrid eConsent combines digital flexibility with the adaptability to meet local, family, and site needs, which is essential for pediatric enrollment.
This study shows informed consent need not be a bottleneck.
Nubilaria’s combination of regulatory know-how, practical operations, and patient-focused technology helped the Sponsor address pediatric enrollment challenges.
The ACTide hybrid eConsent approach enabled separate parental consent workflows, supported participant assent, maintained regulatory compliance, and simplified site operations, all within a single, controlled framework.
If you manage complex pediatric trials or face remote enrollment challenges, ACTide eConsent can help maintain compliance and accelerate onboarding. See below to take the next step.