Clinical trial software development, in production in weeks

Run studies faster without adding operational overhead. Dreamix builds consent, onboarding and integration workflows for CROs, sponsors and research sites, connected to the CTMS, eTMF and EDC systems you already run.

CROs Sponsors Research Sites SMOs
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  • storyMd - Clinical Trial Software Development

“They take pride in the development of the platform and are extremely technically proficient!”

Alexander Tsiaras

CEO, StoryMD

storyMd - Clinical Trial Software Development

Sponsors judge a CRO on cycle times and on how visible the study is while it runs. Very little of the delay sits in the clinical work itself. It accumulates in the gaps: a site waiting on a consent version, a document re-entered into a second system, a status question that takes two days to answer because nobody owns the view across CTMS, eTMF and EDC at once.

Those gaps are where operational friction lives, and they are the part of study delivery that software can actually remove.

Clinical operations team reviewing a study analytics dashboard

Increase study execution efficiency without adding administrative complexity

Every new study, site and country adds coordination, and it never adds proportionally. Past a certain portfolio size, your best people spend more of the week on handovers than on the trials themselves, and cycle times stop improving no matter how hard anyone works.

We automate that layer.

Workflow orchestration

across study startup, site activation and conduct, so a step completed in one system triggers the next.

Automated routine coordination

so study managers spend their time on exceptions.

Live operational visibility

built from the systems already generating the data, so sponsor status questions are answered from a view rather than assembled by hand.

Not sure where your time is going?

Tell us how your studies run today and we will map where the manual handovers actually sit.

Trial participant giving consent remotely on a tablet

Accelerate site and patient onboarding

Consent can cost entire weeks at startup. Someone drafts the form, someone reviews it, someone translates it, someone sends it out to every site. Then it changes, and your team chases each site to bring them current. Doing that on paper takes up a lot of time and effort.

Our iConsent accelerator digitises the whole consent workflow.

  • Consent form creation through a dual-methodology engine, combining predefined compliant data fields with AI-supported generation, so teams draft, customise and deploy forms in a fraction of the usual time.
  • A centralised consent database, so every consent and every version lives in one traceable place across all studies and sites, with full audit visibility rather than a filing exercise before an inspection.
  • Remote patient consent, so participants log in securely from anywhere and approve their participation in a single click, which fits how modern telemedicine and decentralised studies already work.

The same approach extends to site onboarding and document exchange, where the pattern is identical: a document that needs to reach the right people, in the right version, with a record of who saw it and when.

Reduce manual handovers between clinical systems

CTMS, eTMF, EDC and patient-facing systems are usually bought separately, at different times, sometimes by different parts of the organisation. Each does its job, but they’re not inherently designed to work together. So someone needs to spend time keeping them in sync: re-keying, cross-checking, exporting between spreadsheets..

We build the integration and orchestration layer that closes those gaps.

CTMS

eTMF

EDC

ePRO & patient-facing

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Dreamix integration and orchestration layer

Production integrations with Veeva and Oracle, built and running. The same approach applies to Medidata Rave, Florence eBinders and other CTMS, eTMF and EDC platforms, which expose comparable APIs.

Orchestration across systems, so a completed step propagates automatically instead of generating a task for someone to copy it forward.

A single operational view assembled from the systems you already run, rather than a new system for the team to maintain alongside the others.

We work alongside your existing platforms. Replacing a validated CTMS or EDC is a far larger programme than the friction usually justifies.

Built where privacy is the hard requirement

Secure Clinical Trials Communication Solution

With Pryv, we built a modular white-label communication tool for clinical trial teams, designed to integrate with existing legacy software and hardware. It was built privacy-by-design and to GDPR, HIPAA and Swiss DPA requirements, with consent management embedded rather than added on. Participants get secure access to their trial status and their data protection consent is respected throughout, including the right to withdraw from a trial and have their personal record permanently deleted. Clinical data stays organised and transferable under the security standards the study requires, and researchers can navigate an individual participant’s health record without leaving the platform.

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The accelerator built for clinical research

An accelerator is a pre-built solution framework. The architecture, the core components and the integration patterns are already built and tested. We customise the remainder to your studies and connect it to your systems, which is what makes a 60 to 90 day production timeline realistic.

iConsent

Digital informed consent for clinical trials. Turns consent creation into a fast, compliant process through a dual-methodology engine that combines predefined compliant data fields with AI-supported generation. Every consent is stored in a secure, traceable central database with a real-time audit trail, so teams have visibility and control over each consent across every study and site. Patients approve their participation remotely in a single click, in line with a telemedicine approach. Built for teams running multiple complex studies at once without adding manual overhead.

Time from project start to a working solution in production

60 to 90 days

Customise, integrate and deploy iConsent where it fits the use case.

12 to 24 weeks

Build a focused bespoke workflow from scratch and deploy the first production release.

Phased for larger programmes

Useful functionality goes live early rather than waiting for the full scope.

Both timelines assume your integration environments and a named clinical operations owner are available from week one.

We design solutions to EU Annex 11 and ICH GCP. Audit trails, access control and data lineage sit in the architecture from the first session rather than getting bolted on before an inspection.

We maintain a traceability matrix linking requirements to tests, and we produce validation documentation as part of the engagement, including a final report. Your QA team gets the evidence it needs to put the system into a regulated study.

FAQs

CTMS, eTMF, EDC, ePRO and patient-facing systems, plus the EHR and laboratory systems at your sites. We have production integrations with Veeva and Oracle. Others we connect through vendor APIs, standard exports and, where that is all that exists, file-based interfaces. We start by mapping what you run and what each system is permitted to do, because that determines the shape of everything else.

Yes, and that is the usual case. We build the workflow and integration layer around your validated core systems. Replacing a CTMS or EDC is a much larger programme with a much longer path to production, and it is rarely what the operational friction actually requires.

All three. The work differs. Sponsors usually come to us for visibility across a portfolio and for consistency between the CROs they use. CROs come to us for delivery speed , operational efficiency and better scalability across studies.. Sites and SMOs come to us for onboarding and consent, because that is where their administrative burden concentrates.

Sixty to ninety days where iConsent fits the use case, from project start to production. A bespoke workflow reaches its first production release in 12-24 weeks.

A clinical operations owner who can make workflow decisions, access to a test environment for the systems we are integrating with, and someone from IT or your validation team for the integration and compliance questions. We handle the rest, from discovery through production and support.

You do, entirely, including the customisations to the accelerator.