LinkedIn·Thursday, 6 August 2026·20d ago
Your clinical trial can be operationally connected and still feel completely disconnected to the participant. 🧠Sponsors, CROs, sites and…
Vivanti
983 followers
Your clinical trial can be operationally connected and still feel completely disconnected to the participant. đź§
Sponsors, CROs, sites and specialist partners each need systems and processes that support the part of the trial they own.
Participants experience the joins between them.
A recruitment message sets one expectation.
The consent process introduces a different tone and level of complexity.
Onboarding requires another account or channel.
Visit reminders provide dates without enough context.
Ongoing communications assume that uncertainty, anxiety and practical burden have remained unchanged since enrolment.
No individual touchpoint needs to fail dramatically.
The burden accumulates between them.
The amended UK Clinical Trials Regulations are now in force, with updated Medicines and Healthcare products Regulatory Agency guidance continuing to clarify sponsor, investigator and delegated responsibilities. Across Europe, ICH E6(R3) reinforces quality by design, proportionate oversight and attention to factors that matter to trial quality.
Neither framework prescribes one connected participant communication layer. Our view is that fragmented communication should still be considered within quality-by-design discussions, particularly where it contributes to avoidable burden or uncertainty.
đź§ The relevant test is not simply whether information was issued or consent was recorded. It is whether the participant understood what was happening, knew what came next and could find support when their situation changed.
This does not require pretending that every underlying trial system can be replaced by one platform.
It requires a more connected participant-facing layer across recruitment, education, consent, onboarding and retention.
That is where AVA Medical and Vivanti’s connected participant work can contribute.
We create clear, medically reviewed content and digital journeys that help participants move from first interest through informed consent and continued participation, while keeping formal regulatory and ethics requirements where they belong. đź”—
Participant centricity should survive operationalisation.
Otherwise, it remains an insight gathered during design rather than an experience delivered during the trial.
Reflection:
At which hand-off does your participant experience become someone else’s responsibility?
#ClinicalTrials #PatientEngagement #AVAMedical #ClinicalOperations #ParticipantExperience
💬 1↻ 2
View on LinkedIn Cross-referenced
Related on the wire
A shortage response can be agreed centrally and still fail in the last mile. 🚨 EMA’s July activity included a proposed harmonised…
AI in training is easy to overhype. So, we asked someone who actually works with AI where the real value is. Luiz brings a Ph.D. in…
Human-in-the-loop sounds reassuring. Until you calculate how many humans you actually need. ⚖️ Many early AI governance models rely on…
Your experts have limited time. Their expertise doesn’t have to. That’s where AI avatars become much more interesting than a video tool.…
Regulatory advice can change the development strategy while the organisation continues using materials built around the old one. 📄…
Your electronic product information (ePI) implementation could go live without making the information meaningfully easier for an HCP to…