Where the patients are, that is where the evidence starts.
Post-market and real-world evidence for pharma and rare disease: observational studies, PASS/PAES, registries and patient support programmes. When patients are dispersed and specialists are scarce, phygital design is what makes the evidence possible.
Real life happens far from the site.
Across oncology, chronic conditions, specialty care and rare disease, patients live their treatment at home, in the community and with their own doctors. Site-centric models capture only the fraction of that journey that walks through the hospital door, and recruitment and retention pay the price. Rare populations make the gap obvious, but every post-market and real-world programme faces the same distance.
A programme built for dispersed populations, from broad indications to rare disease.
- Post-market & real-world evidenceObservational, PASS/PAES, registries, RWE and patient support programmes, the real-world evidence a molecule needs after launch.
- Decentralised by necessityReach dispersed and rare populations through phygital design and communities.
- Care continuityTrained territorial HCPs can deliver routine-care procedures, keeping patients with trusted doctors.
- Paediatrics, hospital + territoryFor paediatric and rare-paediatric studies we combine hospital centres with territorial paediatricians, reaching families where care actually happens.
- Integrated captureImaging, biomarkers, wearables and ePRO unified in one ECS® record, with pharmacovigilance (PV) safety monitoring built in.
- Evidence strategyAIRA designs the evidence path across indications and settings.
The scientific rationale.
- Full-spectrum clinical and scientific evidence is needed across the product lifecycle, from early research to post-launch.
- Regulatory-ready data must satisfy regulators, clinical stakeholders and scientific communities alike.
- Rare and dispersed populations demand designs that reach patients where they are.
Full-spectrum evidence generation, tailored to the molecule and its lifecycle.
Interventional evidence
- Interventional, randomised, controlled and crossover designs
- Pragmatic study execution
- Post-market evaluation and commitment studies
- Quality systems aligned with ICH-GCP and international standards
Observational & epidemiological
- Observational and PASS/PAES studies
- Registries, EHR-based and ambispective studies for longitudinal and rare-disease insight
- Real-world effectiveness and benefit-risk assessment
- Patient support programmes and HEOR/HTA evidence
Specialised research, specialised partner.
- Rare-disease real-world studies are more complex and more likely to be outsourced, our ecosystem is built for them.
- Decentralisation lifts participation where geography is the barrier.
- One source of truth supports a molecule across multiple indications and its whole lifecycle.
- Scientific ownership sits with a named lead in our AIRA practice.
Strengthen small-population designs, responsibly.
For small and rare populations, synthetic cohorts and a synthetic external control arm can strengthen a design where recruitment is hard, applied responsibly, in line with emerging regulatory precedent.
Rare-disease studies designed around the patient.
We design evidence against the framework that regulates your product.
The design of a study, endpoints, population, comparator, statistical plan, is a function of which authority will read the evidence. We start there.
- CTR · Regulation (EU) 536/2014Clinical trials, EU
Interventional trials submitted and run through CTIS, with harmonised assessment across member states.
EvidencePre-registered protocol, defined endpoints, transparency and results posting obligations. - ICH E6(R3) · Good Clinical PracticeQuality by design, technology-neutral
Sponsor and investigator responsibilities, including decentralised and D-T-P elements (Annex 2).
EvidenceRisk-based quality management, proportionate controls, data provenance across every setting. - EMA · FDA post-authorisationPASS / PAES and real-world evidence
Safety and efficacy commitments after authorisation, including registries and observational designs.
EvidenceProspective, retrospective and ambispective studies, patient registries, EHR-based research. - Orphan & rare disease frameworksSmall populations, high stakes
Orphan designation, adaptive and decentralised designs where the cohort is dispersed and ultra-rare.
EvidenceFeasible designs built around the participant, with regulatory scientific advice sought early.
The journey follows the prescribed treatment.
In real-world studies the therapy is chosen by the clinician, ECS® reconfigures visits, ePRO cadence and device streams around what is actually prescribed.
- Treatment-aware branching
Arms activate from the regimen captured at baseline.
- Dynamic cadence
ePRO, televisit and device frequency follow the therapy's rhythm.
- Live re-routing
Dose changes and switches reshape the rest of the journey.
Evidence builds medical equity, and the right to lead the scientific conversation.
In pharma, evidence is not only regulatory or payer-facing. It is what earns HCP attention across switch, line-extension and consumerisation stories, opens scientific dialogue and lets medical affairs carry new content into practice.
Medical equity
A defensible evidence base that positions the therapy inside the medical conversation, including for switch, line-extension and Rx-to-OTC.
Scientific authority
Peer-reviewed publications, congress data and KOL alignment that let the brand co-author the category narrative.
HCP engagement licence
Evidence medical affairs, MSLs and reps can carry, turning detailing into scientific dialogue and education.
Delivered through AIRA, advisory boards & KOL and publication & scientific communication.
Generate the pharma evidence others build on.
Tell us about your molecule and indication. We'll show you the phygital evidence path, from post-approval studies to real-world and registries.