
Biotech/
Pharmaceuticals

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Clinical Development Plan Design (Phase I – IV)
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Program Resource
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Planning & Budgeting
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Cross-Functional Asset Development
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Clinical Development Teams
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Strategic Program Planning & Resourcing
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Asset Pipeline & Lifecycle Management
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CDP Risk Management & Mitigation
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Translational Development Transition & Management
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Laboratory Information Management System (LIMS)

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Clinical Project Management Phase I – IV
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Study & Site Management
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CRO & Vendor Selection & Management
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Site Contracts & Budgets
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Site Monitoring
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SOP Development & Compliance
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TMF Management
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Project Budget Analytics
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Clinical Staff Coaching & Mentoring
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High Performing Functional Leads
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Competitive Intelligence & Metrics (Dashboards)
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Laboratory Information Management System (LIMS)
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Quality Management Systems
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QA SOP Development
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Site & Vendor Qualification & Auditing (GCP, GLP, CLIA Accreditation)
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Internal Sponsor SOP Audits
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Process Deviation & CAPA Management
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Harmonization & Validation
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Sponsor & Regulatory Inspection Readiness
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Manufacturing Oversight (GMP)
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Computer Systems Validation

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Project Management
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Data Management Plan
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CRF Designing
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Customized Database Design, Screen Testing & Development
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Edit, Validation and Design check programming, UAT
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Data Validation
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Data Cleaning
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Local Lab Data Management
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Patient Diary Data Management
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Serious Adverse Event (SAE) Reconciliation
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Manual / SAS® Data Listings Review
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Quality Control – Sample QC & Critical QC and Data Quality Audits
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Database Soft & Hard Lock and Export to SAS®

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Clinical & Marketed Case Safety Reports
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Region Specific & Aggregated Safety Reports
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Scientific Literature Surveillance
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Safety Signal Recognition & Analysis
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Safety Risk Management

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International Asset Registration & Licensing
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Technology Transfer & Asset Integration
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Label Development & Review
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Regulatory Operations Support
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Regulatory Project Management
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Regulatory Activity SOP Development
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FDA & EU (483 Observations, Warning Letters, Consent Decrees) Remediation
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Program & Project Planning
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Resource Allocation & Management
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Budget Establishment, Analysis & Tracking
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Project Scope Definition
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Coach, Mentor & Train others PMs
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Functional Leaders & Team Members
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Success Measures & Metrics (Dashboards)
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Assessments
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PMO & PPM
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Operations & Manufacturing Strategy
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Process Development
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Technical Transfer
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Innovation & Product Development
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Sourcing & Procurement
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Integrated Planning & Analytics
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Supplier Compliance
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Contract Manufacturing Oversight
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Quality Management System (QMS)
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Baseline or Gap Assessment
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Inspection Readiness
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GMP, GCP, GLP
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Supplier/Distributor
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Contract Manufacturer
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ISO 9001
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21 CFR Part 210 & 211
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21 CFR Part 11
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Auditor Training