This content is protected against AI scraping.
Life Sciences DPO–DPIA Factory and AI Governance:
A Three‑Pillar Service to Break Compliance BottlenecksWe bridge the gap between complex data regulations and breakthrough innovation—ensuring your research is audit-proof and market-ready
Three‑Pillar Service Model
A Life sciences DPO and AI governance” designed to Break Compliance Bottlenecks
Life Sciences Outsourced DPO
Sector‑specialist DPO team covering GDPR, UK GDPR, PDPA and global health‑data rules for trials, labs and real‑world data.
Continuous governance, breach management and regulator liaison so internal teams can focus on science, not supervision powered by three team delivery and centralised Privacy360 Platform
DPIA Factory for Clinical and Lab Operations
Industrialised DPIA model with reusable templates for core life science use cases: global trials, central labs, biobanks, digital endpoints and vendor ecosystems.
Workflow‑driven assessments and automated risk logic that cut completion times by up to 60–80% and free capacity for complex, high‑risk work.
Life Sciences AI and EU AI Act Services
AI governance framework aligned with EU AI Act, MDR/IVDR and local rules, tailored for diagnostics, decision‑support and real‑world evidence platforms.
Practical tools for AI system classification, risk assessment, documentation and human‑oversight so innovation stays compliant and audit‑ready.
Outcome‑focused value proposition
Together, these three pillars give life sciences organisations a single operating model for data and AI compliance. You regain control of assessment queues, reduce dependence on scarce internal experts, and prevent DPO, DPIA and AI‑approval work from blocking study start‑up or product launches.
Life Sciences DPO–DPIA Factory and AI Services
Take back control of spiralling compliance costs, unblock study start‑up, and keep AI‑driven innovation on track with a single three‑pillar service built for life sciences.
Power of Combination
Our combined Life Sciences DPO, DPIA Factory, and AI governance services give you one joined‑up model for data and AI compliance, so clinical, lab, and product teams can move faster without increasing risk.
Break the bottlenecks holding back your science
Life sciences organisations face an unprecedented load of DPIAs, DSRs, contracts, and AI risk assessments. Each new trial, platform, or data partnership adds more pressure to already stretched privacy and compliance teams.
Meanwhile, manual, document‑heavy processes turn essential safeguards into bottlenecks. Trial activations slip. Digital products wait for sign‑off. Valuable AI projects stall in “review limbo.”
Our three‑pillar Life Sciences DPO–DPIA Factory and AI service is designed to reverse this. It replaces fragmented, one‑off efforts with a single operating model that is scalable, predictable, and aligned to how your business actually works.
Estimate Your DPIA Savings with the Formiti Factory
Enter your annual Standard DPIA volume to see how much you could save by switching from one‑off assessments to our archetype‑based DPIA factory model.
Life Sciences DPO–DPIA Factory and AI Governance
One integrated three‑pillar service that cuts compliance costs, clears bottlenecks, and keeps data and AI safely under control.
Pillar One – Life Sciences Outsourced DPO
Embedded privacy leadership for trials, labs, and real‑world data, delivered by the Formiti Three Team.
You get an outsourced Data Protection Officer function that understands clinical research, diagnostics, real‑world data, and digital health, not just generic GDPR theory. We embed with your leadership, your study teams, and your vendors so privacy is practical, not abstract.
We help you interpret and apply GDPR, UK GDPR, PDPA and other local laws across your global footprint. That includes clinical trial frameworks, health‑data rules, and the unique challenges of biobanks, labs, CROs, and central platforms.
Continuous governance, not one‑off fixes
Your DPO function becomes a constant partner, not a last‑minute reviewer. We support:
-
Governance frameworks and policy suites tailored to life sciences.
-
Oversight of trials, platforms, vendors, and data‑sharing arrangements.
-
Regulator engagement, breach response, and incident handling.
-
Training for clinical, lab, and product teams in clear, non‑legal language.
The result is a clear line of sight from board to bedside: everyone knows who is accountable, how decisions are made, and what “good” looks like.
DPIA Factory for Clinical and Lab Operations
From one‑off DPIAs to an industrialised engine
Most life sciences organisations still run DPIAs as bespoke documents. Each assessment starts from a blank page, even when the underlying pattern is identical to the last study or platform. Our DPIA Factory changes that.
We design master DPIA blueprints for your recurring use cases, such as:
-
Global interventional and observational clinical trials.
-
Central and speciality labs, including genetic and biomarker testing.
-
Biobanks and long‑term sample / data repositories.
-
Real‑world evidence and registry platforms.
-
Patient apps, portals, wearables, and digital endpoints.
-
AI‑assisted diagnostics and decision‑support tools.
Individual studies and deployments then become parameter‑driven variants. You adjust the specifics; the core risk logic and safeguards remain consistent.
Automated workflows, consistent outcomes
The DPIA Factory introduces structured workflows and reusable content instead of ad‑hoc email chains and scattered files. It enables:
-
Guided questionnaires for study, lab, and product owners.
-
Automatic reuse of existing information about systems, vendors, and safeguards.
-
Standardised risk scoring and recommended controls.
-
Transparent routing for legal, security, DPO, and business approvals.
For standard scenarios, DPIAs can move from weeks to hours. Complex projects still get deep expert attention, but without drowning in repetitive baseline work.
Tangible impact on cost and time
By industrialising DPIAs, you can:
-
Reduce external consulting spend on repetitive assessments.
-
Free internal experts to focus on genuinely novel, high‑risk projects.
-
Cut delays to trial start‑up, site activation, and product go‑lives.
-
Demonstrate consistent, auditable decision‑making to sponsors and regulators.
Instead of seeing DPIAs as a cost centre, you gain a strategic capability that scales with your portfolio.
Life Sciences AI and EU AI Act Services
AI innovation with built‑in compliance
AI is reshaping discovery, diagnostics, and patient engagement. At the same time, the EU AI Act, MDR/IVDR, and national health regulators are raising expectations for transparency, oversight, and documentation.
Our Life Sciences AI services help you design, deploy, and monitor AI systems that are both powerful and compliant. We focus on practical governance that fits the reality of labs, trials, and digital health products.
From classification to continuous oversight
We support you across the full AI lifecycle:
-
Classifying AI systems under the EU AI Act and sector regulations.
-
Conducting AI‑focused risk and impact assessments integrated with your DPIA Factory.
-
Defining human‑oversight models, performance monitoring, and escalation paths.
-
Building documentation and evidence that stand up to regulator and sponsor scrutiny.
Your teams gain clear guardrails for what is acceptable, what needs extra control, and what should not go live.
Why combine DPO, DPIA Factory, and AI into one service?
When each of these functions runs separately, you get silos, duplication, and inconsistent decisions. One team handles DPO tasks, another owns DPIAs, and a third tries to make sense of AI risks. The result is friction, delays, and rising cost.
By unifying them into a single three‑pillar service, you gain:
-
One governance model for data and AI across trials, labs, platforms, and products.
-
A single risk language used by legal, compliance, security, and clinical teams.
-
Shared templates, processes, and evidence, rather than three different versions of “the truth.”
-
Faster, clearer approvals because the same experts, rules, and workflows apply end‑to‑end.
This is how you move from reactive, incident‑driven compliance to a proactive, scalable model that supports growth.
Outcomes for your organisation
With the Life Sciences DPO–DPIA Factory and AI service, you can:
-
Regain control of spiralling compliance costs.
-
Eliminate bottlenecks that delay study start‑up and product launches.
-
Reduce dependency on a small number of internal “hero” experts.
-
Increase confidence in your data and AI decisions at board level.
-
Strengthen trust with regulators, partners, and patients.
When these three pillars work together, compliance stops being a drag on delivery and starts acting as an accelerator for your portfolio. Your teams gain faster, clearer decisions on studies, platforms, and AI projects, with fewer last‑minute surprises or rework. The organisation benefits from predictable assessment timelines, lower external spend, and reduced reliance on a handful of internal experts. Most importantly, you strengthen trust with regulators, partners, and patients by showing that data protection and AI governance are embedded in how you operate, not bolted on at the end.
Frequently Asked Questions
The Three Pillars
Q1. How will this three‑pillar service actually reduce our compliance costs?pproved for use in the NHS?
By standardising DPIAs, centralising DPO oversight, and embedding AI governance into one model, you cut duplicated effort and expensive rework. Your teams spend less time chasing answers and more time using reusable templates, workflows, and decisions, which reduces external spend and internal hours tied up in reviews.
Q2. We already have an internal DPO – can we still use this service?
Yes. The service can operate as a full outsourced DPO or as a co‑sourced partner to your existing DPO. In a co‑sourced model, we take on portfolio work such as DPIA Factory build‑out and AI governance frameworks, while your internal DPO retains strategic ownership and regulatory visibility.
Q3. How quickly can we see an impact on DPIA bottlenecks?
Most organisations see early wins within the first few months as we prioritise your highest‑volume DPIA use cases and convert them into reusable blueprints. As workflows and templates bed in, standard assessments move faster, freeing your experts to focus on complex, high‑risk projects instead of repetitive baseline work.
Q4.Does the AI pillar only cover the EU AI Act?
No. The AI pillar uses the EU AI Act as a core reference point but also considers GDPR, MDR/IVDR, local health regulations, and your own internal risk appetite. The goal is to give you a consistent framework for classifying, assessing, and monitoring AI systems across all key markets, not just the EU.
Q5.What types of life sciences organisations is this service best suited for?
The service is ideal for sponsors, CROs, central labs, biobanks, and digital health or medtech providers handling multi‑country studies and data platforms. It is especially valuable where you face growing DPIA backlogs, aggressive AI roadmaps, and a need to demonstrate robust governance to regulators, partners, and boards.
Ready to turn compliance back into an enabler?
If DPIAs, DPO tasks, and AI reviews are slowing your science, it is time for a different model. Our three‑pillar service is built specifically for life sciences and health technology organisations that need to move fast, globally, and safely.
Talk to our Life Sciences Team to explore how the combined DPO–DPIA Factory and AI services can help you break bottlenecks, cut costs, and build a compliance capability that grows with your portfolio.
Quick Links
About Us
Services
Projects
Blog
Contact Us
Branch Offices
Ireland
6 Fern Road, Sandyford Dublin,D18 FP98, ,Ireland
Switzerland
Chamerstrasse 172, 6300 Zug (eigene Büros)
Thailand Village Chai Charoen Ville Project 7 88/103 Village No. 8, Nakhon Sawan Tok, Subdistrict Mueang Nakhon Sawan Province 60000, Thailand
Headquarters
Grosvenor House, 11 St Pauls Square, Birmingham B3 1RB, UK
+44 (0) 1215820192
Follow Us
