How MRN turns operational complexity into a seamless experience for sponsors, sites, and patients.
Not a Buzzword – A Discipline
Decentralized Clinical Trials, or DCT, moved from a niche approach before the COVID-19 pandemic to a standard part of the pharmaceutical and Clinical Research Organisation vocabulary in the years since. But it is not just industry shorthand. The word means something specific: every part of the conventional clinical trial is taken apart and rebuilt around the patient. As we like to say, the “D” in DCT stands for decentralised, not digital.
In practice, that means coordinating lab kits, supplies, Investigational Product (IP), and samples sent Direct-to-Patient and Direct-from-Patient. It means identifying, training, and supporting Healthcare Professionals across states, countries, and continents. It means delivering complex in-home procedures, from IP infusions lasting many hours to PK sampling, vital signs, physical examinations, and ECGs. It means integrating all of this with existing brick-and-mortar sites, dividing the schedule of assessments between conventional visits and home or remote visits, and coordinating couriers to ship samples across regions under strict temperature-control and chain-of-custody requirements.
Participant and Protocol Come First. The Operational Design Flexes Around Them.
The participant and the protocol are the fixed points. Everything else – the operational design around them – is what flexes. A participant going on holiday? DCT redesigns the logistics to deliver the visit to them, on schedule and in line with protocol requirements. A participant needs to move a visit within the permitted window? DCT re-coordinates the operational plan around them. Different participants prefer different visit formats? DCT adapts delivery accordingly, without adapting the protocol. Severe weather disrupts Healthcare Professional or courier travel? DCT rebuilds the logistics so the visit still happens as required
Home visits, virtual sites, tele-health, participant and caregiver travel, and conventional site visits all have to work together in service of the participant and the protocol — operational design tailored to the drug, the country, and the sponsor. It sounds simple. It isn’t. But it is worth it.
“The ‘D’ in DCT stands for decentralised, not digital.”
The Results Speak for Themselves
Done well, this model opens participation to patients who may never otherwise have been able to take part. It reduces the burden of participation and expands patients’ choice in how they are treated. We have supported participants in the most rural regions of Australia, and Healthcare Professionals have flown across the United States to bring specialist care directly to the people who need it. Participants have been able to go on holiday, to school, to work — and remain part of a trial throughout.
- Recruitment rates have doubled on trials using this model
- Retention rates have reached upwards of 90 percent
When a sponsor asks “can you do this?”, the answer is almost always yes. DCT thinks on its feet and finds a way.
“When asked ‘can you do that?’ — the answer is almost always yes.”
What It Takes Behind the Scenes
Behind every “yes” is a team: clinical operations, project management, procurement, vendors, Principal Investigators, nurses, physicians, data management, technology, couriers, laboratories, and pharmacies, all rebuilding their processes to make the end-to-end DCT journey work. It takes deep expertise, and it takes learning from failure. Only organisations that have done this for decades, adapted through early setbacks, and built their processes from the ground up can operationalise DCT reliably, trial after trial.
That is why choosing the right team is a key decision a sponsor will make. From that moment, the vendor, CRO, and sponsor need to operate as one cohesive team, delivering a solution that genuinely makes a difference for participants and sites.
Experience Earned Is Experience That Matters
Our sponsor and CRO partners understand this and it is a sign that both recognise decentralised trial delivery as a specialist discipline in its own right, one that rewards deep, hands-on expertise rather than a generalist approach.
For sponsors and CROs weighing that choice, the question is simple: who has actually done this, at scale, for long enough to have learned what works? We take the burden so sponsors, sites, and participants don’t have to.