For pharma, biotech and medtech
A senior consultancy team across biometrics, regulatory, market access, medical affairs and AI, with your data as the golden thread. So every decision, from first protocol to final price, is made with the regulator, the payer and the patient in view.
The problem
Genomics, biomarkers and rare-disease programmes mean smaller populations and higher evidence bars. Regulators and payers ask for more, earlier.
Yet most programmes still run function by function, vendor by vendor. The trial is designed for approval alone, the value story arrives after Phase III, and the data from one study rarely informs the next. That is where time, money and patients get lost.
Our approach
We work back from the label, the HTA decision and the patient, so the trial you design today produces the evidence you will need at launch.
Every dataset, from first-in-human to real-world evidence, should inform the next decision. We make sure nothing you collect is wasted.
AI and machine learning do the heavy lifting. Senior experts guide them, check them and own every judgement, so you move faster without losing rigour.
Solutions
Bring us one challenge or the whole programme. Every practice draws on the others, so the answer to a statistical question already accounts for the regulator, the payer and the clinician.
Statistics that de-risk every decision.
A clear route through the FDA, EMA, MHRA and beyond.
Evidence payers can’t ignore.
From insight to impact, in every channel.
AI that earns its place.
Turn your data into a strategic asset.
Partnership models
Every organisation resources differently. Choose one model, combine several, and change the mix as your programme evolves.
A defined challenge, scoped and delivered, from a single analysis to the set-up, monitoring, reporting and delivery of a study.
Discuss a projectDedicated functional teams, or blended study teams, that strengthen your operation and work to your processes.
Discuss FSPTargeted senior expertise in data, analytics, regulatory, access and change, exactly when a decision can’t wait.
Book an expertSeasoned executives, from COO to Chief Commercial or People Officer, without the cost of a permanent full-time hire.
Discuss leadershipSpecialist recruitment across development and commercialisation, from single roles to RPO, including FSP-to-permanent conversion.
Discuss hiringResults
A few recent engagements. Clients stay anonymous; the outcomes don’t.
A global infectious-disease pharma wanted to move from interest in AI to real capability. We built a regulatory-focused AI roadmap, aligned priorities through collaborative workshops, then ran a targeted pilot in CTA and Module 3 authoring. The 70% time saving validated the approach and opened the way to responsible, scalable adoption across the organisation.
Read the case studyAward for innovation
Strategists needed fast access to the data behind past approvals. We built a centralised platform with bespoke visualisations and advanced filters to slice the data by team and project. It won an award for innovation, and user feedback was extremely positive.
Read the case studyGovernance-led roadmap
Leadership training, structured use-case discovery and a governance-led AI strategy gave the team a clear, prioritised roadmap, aligned with scientific and regulatory expectations and built to scale safely.
Read the case studyWhy we exist
In early 2024, our CEO Andrew MacGarvey met a father whose daughter lives with an ultra-rare genetic condition. He was raising the money to fund the science himself, racing the clock for a treatment the system was never designed to deliver.
Today’s development model was built for blockbusters, and it has given us remarkable medicines. But personalised medicine is shrinking target populations, sometimes to a handful of patients, and incremental fixes won’t close that gap.
So we brought together the best people we know, across AI and machine learning, analytics, regulatory, market access and medical affairs, to build development processes that match the science. People who will go above and beyond to move the needle.
Our mission
To transform drug development and accelerate access to new treatments for all patients.
Our people
Our leaders have run trials, written submissions, worked inside the regulator and won landmark HTA decisions. Between them: more than 140 years in drug development.
Chief Executive Officer
25+ years in clinical development
Chief Scientific Officer
Former Director of Statistical Consultancy Services, University of Oxford
EVP Regulatory Affairs
18 years in regulatory affairs, including the MHRA
EVP Medical Affairs
30+ years across pharma and global health communications
EVP Data Services & Advanced Analytics
25+ years in data-driven roles in pharma
EVP Market Access & HEOR
25+ years, including landmark HTA approvals in rare oncology
VP, Head of Data Science
20+ years across digital innovation and clinical research
Purpose-led people, wanted.
We’re building the team that will change how medicines are developed.
See careersTherapeutic experience
Insights
Medical Affairs strategy has never been stronger, yet the link to real-world engagement is breaking. Why it happens, and how to rebuild it.
Small populations, thin evidence and fragmented care make every decision count. Where Medical Affairs adds value across the rare disease lifecycle.
Lessons from the second and third EU JCA reports, and early signs that national HTA bodies will keep applying their own evidence standards.
FAQs
Can’t see yours? Call us on +44 20 7870 1030 or send us a brief.
Not in the traditional sense. We’re a consultancy-led professional services organisation. We can advise on strategy, embed specialists in your teams through functional service provision, or deliver projects end to end, including study set-up, monitoring, reporting and delivery.
Yes. We support everyone from biotech start-ups preparing a first-in-human trial to global pharmaceutical companies running complex multi-centre programmes, as well as medical device companies.
We use AI where it adds real value, with experts in the loop to guide, check and own every output. Our work is governance-led, covering compliance, data quality, bias mitigation and responsible use. In one regulatory pilot, AI-assisted CTA and Module 3 authoring saved 70% of the time.
Our team works with the FDA, EMA, MHRA and other global agencies, and builds evidence for EU Joint Clinical Assessment, national HTA bodies, ICER and Medicare.
Our experience spans oncology, rare diseases, cardiovascular, cell and gene therapies, paediatrics, immunology, neurology, infectious disease and more.
Yes. A gap analysis or a focused piece of on-demand consultancy is a quick way in, and we work alongside your existing teams and vendors.
Very. Choose project-based work, functional service provision, on-demand consultancy, fractional CxO support or help to build your own team, and change the mix as your programme evolves.
Coronado Research is Cyber Essentials certified, and we’re happy to work under your NDA and data-handling requirements from the first conversation.
We’re headquartered in the UK, with our registered office in Sevenoaks, Kent, and we support sponsors internationally.
Talk to an expert
Tell us about your programme and the right senior specialist will come back to you. We aim to reply within one working day.
Confidential from the first conversation. We’re happy to sign your NDA.
