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Clinical study app: what the sponsor should prepare before development

By Gaspard Chevassus·Published 13 November 2026·6 min read

Hand-built folded-paper model of successive study visits, joined by cotton thread and held by a deep teal sleeve.

Before developing an app for a clinical study, the sponsor should define its role in the protocol, the data it collects and each party's responsibilities. The ethics and regulatory pathway, hosting, connections to existing tools and funding through study closure also need to be clarified. These decisions establish a scope that can be costed and prepare the study to start with participants.

Start with the protocol and the participant's journey

A questionnaire completed at home, an electronic case report form companion, a connected sensor and patient follow-up create different needs. Describe a complete study visit first, including what happens when a response is missing or a phone stays offline.

Before requesting a quotation, gather:

The study objectives, endpoints, visits and response windows for ePRO questionnaires, meaning outcomes reported by participants.
The users, languages, devices and support needs of participants.
Each data item's route, from entry or sensor to the reference database and then to analysis. Identify who can view, correct and export it.
The response to a concerning value. Who receives an alert, during which hours and with what expected action? A research questionnaire should not imply continuous medical monitoring unless that service is arranged.

This data-flow map helps decide what the app adds to existing tools and what the research team will need to handle.

Place the app in the ethics submission

The Human Research Act, or HRA, governs human research projects within its scope. The FDPIC outlines its principles in Human research. The following orientation helps prepare a discussion with your clinical research centre and regulatory specialists; it is not legal advice.

Have the study type and applicable ordinance confirmed. The swissethics Study protocols distinguish clinical trials under ClinO, research other than clinical trials under HRO, and device investigations under ClinO-MD. Using an app does not determine this pathway on its own.

Applications go through the portal described in the BASEC Quick Start Guide to the competent committee, such as CER-VD for Vaud or CCER in Geneva. Prepare a consistent description of the app across the protocol, participant information, questionnaires and data management plan. Agree with the committee which supporting documents and versions to provide.

For electronic consent, the eIC guidance guide specifies submission materials and expectations for validation, identification and signature. Plan the participant's copy and withdrawal of consent too. A checkbox does not describe that process adequately.

Align development with the study calendar

We recommend preparing participant journeys and tests with synthetic data while the submission is under review. Allow time for clarification requests and final-version verification. Starting with participants depends on the applicable authorisations and institutional validation, as well as software delivery.

Protocol and fundingDefine measurements, data flows and responsibilities. Budget scoping, development and continuity.

Ethics submissionDescribe the intended use, questionnaires and participant information. Prepare mock-ups and synthetic data.

Development alongside reviewTest collection and exports with synthetic data. Address feedback, document changes and validate the selected version.

Study openingApplicable authorisations obtained, version validated, team trained and support ready before the first participant.

If the app carries eConsent, reassess changes with the regulatory team. The swissethics guide notes that system changes can affect the validity of the consent process.

Data collection tool or medical device?

Intended purpose matters when qualifying software. Swissmedic's Medical Device Software information sheet distinguishes simple storage or communication from processing for an individual medical purpose. It refers to the Medical Devices Ordinance, MedDO.

Does the software have an individual medical purpose or control a device?

Yes or uncertainAsk specialists to assess device qualification and requirements.

NoExamine what it does with the data.

Does it only collect, store and transmit, without medical interpretation?

YesDocument the collection role and its limits. Confirm qualification.

No or uncertainHave the functions assessed before fixing scope and budget.

Describe the actual functions, including image analysis, recommendations or device commands. This diagram prepares an assessment; it does not determine qualification. Avoid promising a diagnosis in screens or documents if that intended purpose has not been assessed.

Decide where data lives and who can access it

The revised Federal Act on Data Protection, or nFADP, is a starting point to examine according to the parties involved. The FDPIC distinguishes its supervisory remit from that of cantonal authorities. For a public hospital, ask its competent service to clarify cantonal and institutional rules. Patient data disclosure also explains the sensitivity of health data and professional secrecy.

Request a plan naming the data controller, providers, storage and backup countries, and locations from which support staff can access data. A server in Switzerland does not describe every access route. Assess foreign disclosures against the FDPIC's conditions in Cross-border transfer.

Specify named accounts by role and centre, appropriate authentication, separation of the identification key from coded data, a record of corrections and tested restoration. Have your institution validate these choices and data-processing contracts.

Reuse the tools already in place

Before commissioning an app, check what your institution's REDCap instance already covers for questionnaires and study data. Development may be limited to the participant journey, offline use or a sensor connection. Designate the reference database to avoid competing versions of a response.

For exchanges with hospital systems, HL7 FHIR is a standard to discuss with IT, according to the interfaces actually available. Agree the exchanged data, identifiers, permissions and test environment. Naming a standard does not replace that agreement.

Budget through closure

In the grant application, separate scoping, development, integrations, validation and operation during the study. Include changes following ethics review, participant support, maintenance for supported phones and final export preparation.

For funding from the SNSF or Innosuisse, have the grants office check each cost's eligibility. It depends on the funding instrument and its conditions; a development quotation does not guarantee funding.

Decide who keeps the code, accounts and access when a colleague leaves. At study end, who stops reminders, closes accounts, produces the export and funds a readable archive? Have retention periods and the handling of backups established for the study's regulatory framework. For eConsent, the cited guide explicitly addresses archiving and readability after closure. Stopping the app and deleting data are separate decisions.

What we can prepare with your team

For Pneumoscope, we developed the mobile app for Onescope, a HUG spin-off, with the clinical and research teams. Our contribution to the initial development of Detectra, for Atreon with UNIL-CHUV Rheumatology, covers the patient app, clinical dashboard, FHIR integration and image-related workflows.

These software contributions do not replace the sponsor's or institution's responsibilities. Our clinical research in French-speaking Switzerland page details these collaborations. To prepare a project with us, bring the available protocol, data-flow map and submission calendar; our support for research teams helps define the scope, responsibilities and deliverables to cost.

Sources and references

13 sourcesedoeb.admin.ch · swissethics.ch · basec-faq.swissethics.ch · swissmedic.ch · FDPIC, Tasks · +4

Clinical study app: what the sponsor should prepare before development

Start with the protocol and the participant's journey

Place the app in the ethics submission

Align development with the study calendar

Data collection tool or medical device?

Decide where data lives and who can access it

Reuse the tools already in place

Budget through closure

What we can prepare with your team

Sources and references

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