The difference between a promising digital health tool and one that works in your trial is almost always implementation. OptiTrial exists to close that gap – from protocol design to go-live and beyond.
We work best where the technology challenge is real – where digital health tools need to work for sites and patients, not just pass a demo.
Most sponsors have access to good technology. What’s harder to find is the expertise to configure it against protocol requirements, validate it to GCP standards, and get it running at site level – so patients can use it and sites can support it.
Technology and AI strategies built around your protocol, endpoints, and site operating model
Supplier selection frameworks that hold up under scrutiny – internally and with auditors
Delivery that connects configuration, UAT, validation, and site readiness from the start
Rolling out ePRO across a global programme or deploying eConsent for the first time – we provide the delivery experience to get systems configured, validated, and running at site level. On time and inspection-ready.
Protocol alignment, GCP compliance, and site usability are different challenges from building a good product. We help technology companies close that gap, win sponsor trust, and keep it.
Sponsors need technology that works at site level. Vendors need to understand how trials actually run. OptiTrial sits at that intersection – and has done for over 13 years.
We do fewer things than a big consultancy or a CRO. We do them properly, with people who’ve done them before.
Protocol digitisation, AI adoption frameworks, and site-level operating plans grounded in how trials actually run – not just how they look on a slide deck.
Objective, structured evaluations that go beyond the sales pitch. RFI/RFP design, market scans, and GCP-aligned qualification documentation your team can defend internally and to auditors.
Hands-on configuration, UAT management, and site enablement across sponsors, CROs, and vendors. eCOA, ePRO, eConsent, wearables, and remote monitoring – with inspection-ready documentation throughout.
Requirements translation, workflow review, and delivery playbooks grounded in how trials actually run. Helping technology providers and sponsors align on what the product needs to do at site and patient level.
Most technology providers know their product. What they often lack is someone who has been inside the audits, run the UATs, and delivered against GCP standards across live programmes.
We bring that delivery experience to help suppliers get inspection-ready and stay that way – from validation planning and UAT documentation through to audit support and compliance gap analysis.
Choosing technology before defining the operating model – then discovering it doesn’t fit how sites actually work
Treating patient-facing technology as a low-priority add-on, rather than a core delivery risk
Underestimating the UAT and validation effort until it delays go-live or triggers a finding
Designing for the protocol on paper, not for the sites and patients who have to use it in practice
I’ve spent over 13 years working on some of the most complex digital clinical programmes in the industry – configuring systems, managing vendors, running UATs, and sitting in the audits. I founded OptiTrial because I kept seeing the same problem: great technology, poor implementation. The tools existed. The expertise to deliver them properly often didn’t.
OptiTrial is deliberately focused. We work with sponsors, CROs, and technology providers on challenges at the intersection of clinical trial operations and digital health technology. We don’t do everything. We do the things we know well, to a standard that holds up under scrutiny.
We’ll give you a clear view of what’s worth doing and what’s not. No lengthy pitch process. Just a straightforward conversation with someone who has worked on these problems before.