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DigiSci
CASE STUDIES

Work we have actually done.

A selection of engagements across CGT, pharma operations and AI. Client details are anonymised at their request, as reported by the clients.

3 engagements shown
AI in Regulated EnvironmentsRegulatory authoring
Global life sciences firm

An AI-enabled regulatory authoring platform

Challenge

Regulatory applications were manually created by SMEs, spending hundreds of consulting hours reviewing hundreds of relevant documents over a 6+ month process.

Approach

We led the programme with the external technology providers, bridging SME needs with the technology providers implementation that exceeds the client specifications.

Impact

Accelerating authoring by 40-60%, while reducing SME resourcing.

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Cell & Gene TherapyQuality systems
Emerging advanced therapy biotech

A digital PQS blueprint for a scaling therapy biotech

Challenge

Batch release ran on disconnected spreadsheets, with batch review averaging 8-10 days as the team scaled for Phase 2.

Approach

We delivered a digital blueprint: identification and quantification of opportunities, an implementation strategy, and multi-vendor evaluations and recommendations.

Impact

Implementation strategy with detailed multi-vendor evaluation assessments, leading to a recommended vendor with full total cost of ownership modelling.

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AI Training
Advanced Therapy Organisation

AI training across a 80-100 FTE organisation

Challenge

Establish AI governance and build AI fluency across a 80-100 FTE organisation.

Approach

We designed an immersive, tiered AI training programme combining classroom and self-learning, grounded in organisational use cases.

Impact

Tailored 3-tiered AI training for 80-100 FTEs, delivered over 3 months. Qualified training metrics to demonstrate adoption.

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