Biotech/

Pharmaceuticals

Clinical

Development

• Clinical Development Plan Design (Phase I – IV)

• Program Resource

• Planning & Budgeting

• Cross-Functional Asset Development

• Clinical Development Teams

• Strategic Program Planning & Resourcing

• Asset Pipeline & Lifecycle Management

• CDP Risk Management & Mitigation 

• Translational Development Transition & Management

• Laboratory Information Management System (LIMS)

Clinical

Operations

• Clinical Project Management Phase I – IV  

• Study & Site Management 

• CRO & Vendor Selection & Management

• Site Contracts & Budgets

• Site Monitoring

• SOP Development & Compliance

• TMF Management

• Project Budget Analytics

• Clinical Staff Coaching & Mentoring 

• High Performing Functional Leads

• Competitive Intelligence & Metrics (Dashboards)

• Laboratory Information Management System (LIMS)

Quality

Assurance

• Quality Management Systems

• QA SOP Development

• Site & Vendor Qualification & Auditing (GCP, GLP, CLIA Accreditation)

• Internal Sponsor SOP Audits

• Process Deviation & CAPA Management

• Harmonization & Validation

• Sponsor & Regulatory Inspection Readiness

• Manufacturing Oversight (GMP)

• Computer Systems Validation

Medical

Writing

• Document Quality Assurance

• CSR & Clinical Protocols

• Publications & Manuscripts

• Regulatory Documents (CMC, clinical & non-clinical)

• Document Development SOPs

• Submission Document Management

Data

Management

• Project Management

• Data Management Plan

• CRF Designing

• Customized Database Design, Screen Testing & Development

• Edit, Validation and Design check programming, UAT

• Data Validation

• Data Cleaning

• Local Lab Data Management

• Patient Diary Data Management

• Serious Adverse Event (SAE) Reconciliation

• Manual / SAS® Data Listings Review

• Quality Control – Sample QC & Critical QC and Data Quality Audits

• Database Soft & Hard Lock and Export to SAS®

Medical

Affairs

• Health Economics & Outcomes Research (HEOR)

• Medical Information 

• Medical Communications 

• Portfolio & Asset Lifecycle Management

• Study Design (Phase IV & Registry Studies)

• Early Phase Indication, Epidemiology & Patient Assessment

Safety & Pharmacovigilance

• Clinical & Marketed Case Safety Reports

• Region Specific & Aggregated Safety Reports

• Scientific Literature Surveillance

• Safety Signal Recognition & Analysis

• Safety Risk Management

Regulatory

Affairs

• International Asset Registration & Licensing  

• Technology Transfer & Asset Integration  

• Label Development & Review

• Regulatory Operations Support

• Regulatory Project Management

• Regulatory Activity SOP Development 

• FDA & EU (483 Observations, Warning Letters, Consent Decrees) Remediation

Project & Program Management

• Program & Project Planning

• Resource Allocation & Management

• Budget Establishment, Analysis & Tracking

• Project Scope Definition

• Coach, Mentor & Train others PMs

• Functional Leaders & Team Members

• Success Measures & Metrics (Dashboards)

• Assessments

• PMO & PPM

Pharmaceutical Operations & Technology 

• Operations & Manufacturing Strategy 

• Process Development

• Technical Transfer

• Innovation & Product Development

• Sourcing & Procurement

• Integrated Planning & Analytics

• Supplier Compliance

• Contract Manufacturing Oversight

Audits

• Quality Management System (QMS)

• Baseline or Gap Assessment

• Inspection Readiness

• GMP, GCP, GLP

• Supplier/Distributor

• Contract Manufacturer

• ISO 9001

• 21 CFR Part 210 & 211

• 21 CFR Part 11

• Auditor Training