Data and AI for the pharmaceutical industry
With the precision this industry demands and the traceability regulation requires
Solutions by function
From the lab to the prescription.
Data and AI across every part of your operation.
CommEx & Sales
Every call, to the prescriber who matters
Next Best Action and HCP targeting built on evidence, not hunches. Your field force knows who to see, with which message and when, and finally measures the real impact of every interaction.
Medical Team / MSL
You know who really drives prescribing
KOL influence mapping with graph analytics across co-authorships and trials, and scientific coverage you keep separate from commercial. So reps and MSLs stop calling the same expert without either of them knowing.
Market Access
The evidence that convinces the payer
Multi-country RWE, cost-effectiveness models and analytics for pricing, reimbursement (P&R) and tenders. You walk into the negotiation with a dossier backed by real-world data, not by assumptions the payer takes apart in minutes.
Omnicanalidad
One physician, one message
Multichannel orchestration and an HCP 360 view that align field calls, email, e-detailing and webinars on a single history. You leave uncoordinated multichannel behind and speak to every HCP with one voice, not three at once.
Sell-out & Market Share
What's happening in the market, not in sell-in
Sell-out, market share and in-market share by brand, channel and territory, all on one screen. Market forecasts and anomalies already flagged, so you react before the problem shows up in sales.
Territory & coverage
Every territory aligned, with no gaps
We find the white space where potential sits uncovered, optimize your field force routing and rebalance workloads. Every hour in the field lands where it pays off most, not where it has always gone out of habit.
Pharmacovigilance
From manual review to supervising models
Forget reviewing case by case. NLP reads ICSRs, literature and social media, classifies every adverse event and ranks it by severity. Your team leaves the routine behind and focuses on the signals that matter.
Clinical trials
The whole trial in a single view
Sites, CROs and systems finally talking to each other. You see the protocol deviation coming before it escalates and select eligible patients with models that get it right. No more running the trial blind.
Regulatory Affairs
Submissions in weeks, not months
Generative AI drafts your eCTD documents and an agent tracks every change from EMA, FDA and AEMPS for you. You hit the deadline without burning your team on repetitive work that adds nothing.
GxP Manufacturing & Quality
The deviation you catch before batch release
Predictive maintenance on critical equipment and computer vision inspecting the line in real time. You catch the deviation before batch release, with a GxP audit trail as standard and ALCOA+ traceability from the first data point.
Supply Chain & traceability
Every batch located, and at the right temperature
You know where every batch is and what temperature it's traveling at. Replenishment forecasting, monitored cold chain and end-to-end FMD/DSCSA serialization. The anomaly flags itself before it reaches your service level.
GxP Data & AI Infrastructure
So your models don't die in a notebook
A cloud platform with ALCOA+ governance and MLOps that takes AI from pilot to production. We validate across dev, pre-prod and prod, and keep it alive so it evolves with you instead of quietly expiring.
Projects in production
What changes when data and AI really work in pharma
Regulatory framework
Regulation isn't a layer you add later. It's part of the design.
ALCOA+ and 21 CFR Part 11
GxP platforms with ALCOA+, electronic signature and a full audit trail compliant with 21 CFR Part 11. Data integrity isn't audited into place. It's designed in.
GxP: GMP, GCP, GLP and GDP
Solutions compliant with the applicable GxP guidelines and aligned with ICH Q10 and EMA and FDA guidance. Compliance, embedded in every process.
GDPR and special category data
Patient and HCP health data processed under GDPR: pseudonymization, RBAC access control and consent managed in the data layer.
ICH E2 and EMA/FDA/AEMPS regulation
PV platforms aligned with ICH E2A to E2F and the EMA, FDA and AEMPS requirements for PSUR, PBRER and ICSR. The regulatory deadline as a design criterion.
ICH E6 GCP and EU Regulation 536/2014
Trial platforms designed around ICH E6 GCP R2/R3 and EU Regulation 536/2014. Data managed to CDISC standards: CDASH, SDTM and ADaM.
CSV and CSA in controlled environments
Implementation across dev, pre-prod and prod with validation adapted to traditional CSV or the FDA's risk-based CSA. Validation documentation ready for inspection.
EU AI Act and AI governance
AI systems compliant with the EU AI Act: risk classification, explainability, traceability and human oversight built in from the design stage, never patched on later.
FMD/DSCSA and product traceability
End-to-end traceability compliant with the Falsified Medicines Directive (FMD) in Europe and DSCSA in the United States, integrated with your supply chain and your ERP.
Farmaindustria and transparency (ToV)
Automated transfer of value (ToV) reporting under the Farmaindustria Code, with full traceability and control of overlap between commercial and medical roles.
