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Pharma Clinical Operations Solution

Pharma Project Charter and Study Setup Copilot

Speed up study startup without risking quality. We connect your SOPs, templates, and prior studies to a governed Copilot, add safe prompts, and set up reviewer flows so teams create project charters and startup packages that are consistent, reviewed and easy to approve.

Tell us the workflow See M365 Copilot Deployment

Audience

Who This Is For

Clinical Operations, Regulatory, Medical Affairs, Biostatistics, Safety, and Study Startup teams that want faster planning and cleaner documentation with clear ownership and version control.

Typical Challenges

  1. Each charter needs approval from many stakeholders, and routing it by email causes delays.
  2. With a manual charter process, work cannot start until the last approval comes back.
  3. Documentation is scattered across systems, creating compliance gaps and slow validation.

Launch

What You Will Launch, One Build at a Time

  1. AI-powered charter and synopsis drafting from your approved templates based on project type, therapeutic area, and budget thresholds.
  2. Automated approval routing that sends each charter to the right stakeholders.
  3. Real-time compliance checks against regulatory requirements, internal policies, and budget parameters with instant feedback.
  4. Unified integrations with SharePoint for documents, Dynamics 365 for project tracking, and Teams for updates and collaboration.
  5. Budget intelligence with automated tracking, resource allocation, and portfolio visibility.

Outcomes

Outcomes You Can Share With Leadership

  • Faster

    charter approvals

    routed to the right reviewers by role

  • Earlier

    project starts

    tracked in cycle-time telemetry

  • Fewer

    documentation gaps

    through automated validation

  • Less

    reviewer rework

    drafts start from your approved templates

“First drafts were usable on day one. Reviews focused on science and risk, not formatting or missing sections.”
Client Note

Blueprint

How the Study Setup Copilot Works

From blank page to approved plan

Template Mapping

We map your charter, synopsis, risk, and startup templates so Copilot generates drafts in your structure and wording.

Knowledge Curation

We connect SharePoint libraries and approved sources so every draft includes citations back to SOPs, labels, and prior studies.

Safe Prompts

We apply prompt patterns for critical sections like objectives, endpoints, and monitoring, with guardrails for risky intents and reviewer routes.

Country Overlays

We maintain overlays for market specifics and highlight differences for quick review and approval.

Reviewer Routing

Submissions move through a simple flow with timestamps, comments, and a clean package for records after approval.

Evidence and Telemetry

You get a tidy evidence pack and dashboards that track throughput, bottlenecks, and rework.

Architecture

Technology Architecture

Power Platform Integration

Power Apps, Power Automate, and Power BI for charter analytics

SharePoint Connectivity

Version control, regulatory libraries, and approval tracking

Dynamics 365 Integration

Project lifecycle, budget tracking, and milestone management

Teams Collaboration

Notifications, updates, and status visibility

Key Differentiator

Purpose-Built for Pharma Charter Management

Not a generic workflow tool, with architecture that understands R&D processes and governance.

Flows

Featured Flows

Create a Project Charter

Answer a few questions and generate a draft with required sections and citations.

Build a Startup Package

Assemble a checklist for ICF, site list, budget inputs, and training plan with the right reviewers by role.

Update After Protocol Changes

Regenerate only affected sections and flag diffs for faster review.

Risk and Quality Plan

Draft monitoring, data review, and deviation handling with links to SOPs.

Rollout

Rollout Plan

One workflow goes live at a time. Larger rollouts run as a series of scoped builds, each with its own signed acceptance criteria.

  1. Scope, before build one

    Assess

    Charter process mapping, stakeholder interviews, environment assessment, and requirements with R&D, finance, legal, and regulatory teams.

  2. Build one

    Build

    Power Apps development and template creation, workflow configuration, SharePoint and Dynamics setup, UAT and security validation.

  3. Later builds

    Deploy

    Pilot on select projects, training and change management, performance monitoring, and optimization toward broader rollout.

See the Full Plan

Scope

What Is Included

  1. Template and SOP mapping with owners and freshness
  2. Copilot prompts and response patterns with citations
  3. Reviewer routing with SLA tracking and evidence packs
  4. Telemetry for throughput, cycle time, and rework
  5. Role-based training for study teams and reviewers

Not included

What Is Not Included

  1. Global change management beyond the pilot team
  2. Custom CTMS or eTMF integrations that require new APIs
  3. Company-wide rollout in one step

(These are delivered in follow-on phases.)

Prerequisites

Prerequisites

  1. Microsoft 365 Copilot licenses for the pilot cohort
  2. Access to tenant security and compliance settings
  3. Named template owners for charter, synopsis, ICF, and startup docs
  4. Reviewer groups and an agreed pilot scope

Security

Security and Compliance

  1. Least-privilege access, sensitivity labels, and DLP before enablement
  2. Guardrails that block unapproved statements and route exceptions
  3. Tenant-level agent inventory and usage telemetry
  4. Audit-ready runbooks and change control with version logs
Copilot Studio Implementation Guide

Case Study

Compliance Case Study

European Pharmaceutical Regulator | AI Compliance Scanner for Marketing Assets

How we built an AI compliance scanner for a European pharmaceutical regulator. It checks marketing assets against national and EU regulations and cuts review time per asset from 2 to 3 hours to about 2 minutes. Each finding links to the regulatory document behind it.

Read Full Case Study
  • ~2 minPer asset, down from 2 to 3 hours
  • 620+Assets scanned in production
  • 11Compliance rules checked per scan

FAQ

Frequently Asked Questions

Do we have to rewrite our templates?

No. We start with what you use today and map it. Improvements can follow once the pilot proves value.

Can the copilot propose text for endpoints and risk plans?

Yes, based on your approved examples and SOPs, always with citations and reviewer routes.

How do you handle country differences?

We maintain overlays in the templates and highlight changes so reviewers see exactly what is different.

Can this post directly to our records system?

We can export a clean package or integrate with your systems if APIs and permissions are available.

How do you keep content current?

We set owners and refresh cycles. Telemetry shows sections that need updates and where reviews get stuck.

Go deeper

Research paper

Compliance-grade RAG: Retrieval systems a regulator can audit

How to build retrieval that a regulated reviewer can trust and audit.

Read the paper
Get the designed PDF

Ready to Ship Study Startup Packages That Reviewers Approve Faster

Tell us the workflow you want fixed. We scope it with you, agree on the deliverables and acceptance criteria in writing, and build it in your environment. Commercial terms are set in the statement of work.

Talk to our team Tell us the workflow
  • Built to SOC 2, HIPAA and GDPR standards
  • EU AI Act-aligned delivery
  • Microsoft Solutions Partner