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, compliant, and easy to approve.
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
12 to 15 stakeholder approvals cause routing delays and email ping-pong.
Manual charter processes often take 4 to 6 weeks before work can start.
Documentation is scattered across systems, creating compliance gaps and slow validation.
What You Will Launch in 60 to 90 Days
AI-powered charter and synopsis drafting from your approved templates based on project type, therapeutic area, and budget thresholds.
Automated approval routing to the right stakeholders with zero manual handoffs.
Real-time compliance checks against regulatory requirements, internal policies, and budget parameters with instant feedback.
Unified integrations with SharePoint for documents, Dynamics 365 for project tracking, and Teams for updates and collaboration.
Budget intelligence with automated tracking, resource allocation, and portfolio visibility.
Outcomes You Can Share With Leadership
“First drafts were usable on day one. Reviews focused on science and risk, not formatting or missing sections.”
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.
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.
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 Plan
Assess
Weeks 1 to 2
Charter process mapping, stakeholder interviews, environment assessment, and requirements with R&D, finance, legal, and regulatory teams.
Build
Weeks 3 to 6
Power Apps development and template creation, workflow configuration, SharePoint and Dynamics setup, UAT and security validation.
Deploy
Weeks 7 to 12
Pilot on select projects, training and change management, performance monitoring, and optimization toward broader rollout.
What Is Included
Template and SOP mapping with owners and freshness
Copilot prompts and response patterns with citations
Reviewer routing with SLA tracking and evidence packs
Telemetry for throughput, cycle time, and rework
Role-based training for study teams and reviewers
What Is Not Included
Global change management beyond the pilot team
Custom CTMS or eTMF integrations that require new APIs
Company-wide rollout in one step
(These are delivered in follow-on phases.)
Prerequisites
Microsoft 365 Copilot licenses for the pilot cohort
Access to tenant security and compliance settings
Named template owners for charter, synopsis, ICF, and startup docs
Reviewer groups and an agreed pilot scope
Security and Compliance
Least-privilege access, sensitivity labels, and DLP before enablement
Guardrails that block unapproved statements and route exceptions
Tenant-level agent inventory and usage telemetry
Audit-ready runbooks and change control with version logs
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.
Ready to Ship Study Startup Packages That Reviewers Approve Faster
Start with a short assessment. Get a plan, a timeline, and a pilot that proves value.