Pharma · Clinical

Personalisierte Lösungen für Pharma Clinical Operations

Wir helfen pharmazeutischen Teams, klinische Workflows, Datenprozesse und operative Umsetzung durch massgeschneiderte organisatorische, digitale und technische Lösungen zu verbessern.

01 · the phase

Klinische Operations liegen im Schnittpunkt aus Patientensicherheit, regulatorischer Rigor und operativer Komplexität, die sich über Jahre zieht. Wir kennen die typischen Engpässe, fragmentierte Daten über Studien-Sites, manuelle Dokumentations-Workflows, die nicht skalieren, Trial-Timelines, die unter Prozess-Schulden einbrechen, und wissen, welche davon sich mit einem 4-Wochen-PoC bewegen lassen.

02 · what we hear

Key challenges, and how AI-driven transformation helps.

  • Study Operations
    Challenge

    Stark heterogene Datenformate bei der Erfassung über viele Sites verlangsamen Planung, Start und Closeout, während Protokoll- und Studien-Dokumentation manuell und papiergetrieben unter strenger regulatorischer Compliance bleibt.

    How we help

    Wir bilden und standardisieren Daten aus mehreren Sites in ein einheitliches Schema mit prädiktivem Timeline-Score ab und entwerfen, verknüpfen und prüfen GxP-konforme Dokumentation automatisch vor, mit vollständigem Audit-Trail.

  • Patient Engagement
    Challenge

    Rekrutierung ist langsam wegen komplexer Studiendesigns und enger Eligibility, und Patienten-Adhärenz wird meist über ineffektive Touchpoint-Besuche verfolgt.

    How we help

    Wir identifizieren Zielpatienten über eine datengetriebene Segmentierung, die sie auf Studienbedarfe matcht, und verbinden Patientendaten mit dem Operations-Team für schnelle, personalisierte Intervention und stärkere Retention.

  • Regulatory
    Challenge

    Eine sich ständig wandelnde regulatorische Landschaft mit diversen Regeln ist schwer nachzuverfolgen und zwingt Sponsoren, sich unter dem Druck einer laufenden Studie schnell anzupassen.

    How we help

    Wir liefern eine intelligente, selbstaktualisierende Suche, die regulatorische Informationen über Produkte und Märkte hinweg synthetisiert, das erhöht die Zulassungswahrscheinlichkeit und verkürzt die Zeit bis zum Launch.

03 · use cases

What a 4-week PoC could target.

Unified clinical data layer

One searchable, decision-ready view across EDC, CTMS and sites.

We consolidate fragmented trial data into a single layer, mapping sources, flows and definitions, so teams stop stitching formats by hand and decisions run on trusted, aligned data.

What good looks like

  • Consolidated, searchable trial data
  • Faster, more reliable decisions
  • Aligned definitions and KPI readiness

Remote & decentralized testing

A patient–physician portal and connected workflow for home/remote testing.

We design and implement the shift from clinic-based to homecare testing, secure patient identification, a web portal connecting patients with their treating physicians, with multi-language and national regulatory requirements built in.

What good looks like

  • Patient- and nurse-driven testing
  • Better physician communication and treatment adherence
  • Compliant and scalable across countries

Trial team & stakeholder alignment

One source of team goals, roles and status, less onboarding churn.

We interview scientists and leads, consolidate the feedback, and stand up a single source presenting roles, goals, FAQs and key documents, cutting redundant introductions when stakeholders or priorities change.

What good looks like

  • Instant visibility for the team
  • Managed stakeholder expectations
  • Less scope churn and re-onboarding

AI-assisted documentation

Draft and check clinical documents against your SOPs, faster.

We prototype an AI workflow that drafts and reviews documentation, for example CSR preparation or audit-trail checks, against your SOPs and standards, with a human in the loop.

What good looks like

  • Faster document preparation and review
  • Consistency with SOPs and standards
  • Earlier detection of gaps

Multi-source clinical insight

Combine diagnostic and trial data for patient-centric insight.

We connect multiple data sources into a cloud-based, AI-driven view that enables more comprehensive, patient-centric insight and better-supported clinical decision-making.

What good looks like

  • Patient-centric, decision-ready insight
  • Integrated multi-source data
  • Better-supported clinical decisions

04 · proof

Work, re-framed for this phase.

Digital Biorepository · Swiss pharma client

Wir haben Learnings aus standortübergreifender Daten-Workflow-Automation in eine klinische Prozess-Umgebung übertragen, dasselbe Rückgrat, anderer Compliance-Rahmen.

Background
Cross-site collaboration on bio-sample management, biosamples (cells, proteins, plasmids, antibodies) distributed across multiple locations with no clear structure. Tracing, accessing and collecting the right samples was slow; scientific productivity was capped.
Solution
A global virtual + physical solution to handle, search and retrieve biosamples. Secure cross-site sharing, AI-contextualised digital + physical storage, and an integrated request → register → store workflow.
Results · 12 mo. after engagement
Remote and centralised access to bio samples. Faster data access. Lower experiment time and cost. ~35% efficiency improvement.
inite's role
inite concepted, designed and managed the full DBR implementation across life-science, IT and business domains. Delivered a standardised Bio-Sample Data Model aligned with FAIR principles. Aligned multiple sites and functions on a single workflow.

“Inite positively influenced a change of mindset and supported us to approach the task with fresh thinking. Their approach allowed the team to imagine solutions in an unlimited way rather than being held back by constraints and obstacles.”

Global Process Owner, Biosample Management · Global Pharma Company

Automated Compound Hub · Swiss biopharma client

Prozess-Disziplin und Stakeholder-Verhandlung aus einem Compound-Management-Rollout, dieselbe Muskelkraft, die eine Phase-III-Studie über CROs hinweg zusammenhält.

Background
Growing global volume of compound orders for powder-solution production with varying priorities. The compound-management team was strained on productivity, sample tracking and prioritisation.
Solution
Personalized Solutions workshop to optimise workflows, then a fully automated platform for powder weighing and liquid handling, designed for global rollout, with throughput, safety and priority handling built in.
Results · 12 mo. after engagement
Daily processing capacity up by more than 500%. Lab processes automated and optimised. Global standardisation of order processing across the department.
inite's role
inite provided a Scientific Business Analyst and Solution Architect. Owned system specifications and the functional-design phase. Architected the high-throughput solution. Negotiated with stakeholders to reconcile business and technical requirements.

“Inite contributed significantly to the success of our projects with excellent and well-founded analyses. Their structure and committed way of working was greatly appreciated by the team.”

Compound Management Director · Global Pharma Company

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