Capabilities

Program Management & Consulting

Business Objectives Effectively Managed & Delivered

Project & Program Management
Operations & Efficiency Consulting
Auditing
Business & Market Intelligence

Project & Program Management

GBC provides day-to-day program project management and consulting services. GBC evaluates resources needed for execution and develops realistic timelines and project plans that meet your vision and are executable within the existing constraints of your organization. GBC works with clients to align their organization with the agreed strategic agenda, initiate the project, and manage the project with a focus on critical project success factors. GBC project management services include:

Project Set-Up

Project Feasibility Assessments
Development of Project Plans, including:
- Scope of Work
- Critical Path (Timeline) Planning and Scheduling
- Resources, Roles and Responsibilities
- Communication Plans
- Deliverables
- Quality Standards
- Milestones
- Project Budgeting
Training and Project Initiation
Progress Metrics Development
Risk Evaluation and Mitigation (REM) Planning

Ongoing Project Services

Project Leadership and Team Management
Timeline Management
Regular Reports, Updates, and Reporting of Progress Metrics
Progress Review Meetings
Ongoing Internal and External Communication
Problem Solving
Project Financial Management and Reconciliation
Change Order Implementation

Project Completion Services

Confirm Project Deliverables are Complete
Conduct Project Completion Audit
Draft, Review, and Disseminate Key Reports
Resolve and Finalize Project Expenses
Review Project Team Performance and Future Training Needs

Operations & Efficiency Consulting

GBC understands that many clients are under pressure to accomplish more with fewer resources, streamlining processes, reducing waste, and improving productivity. GBC works with clients to improve existing capabilities, develop new capabilities, and solve multi-dimensional challenges by focusing on people and processes. GBC organizational consulting services include:

Organizational Consulting

Strategy Consulting
Organizational Structure Consulting
Performance Management Consulting
Business Process Reengineering
Change Management
Crisis Management
Facilities Planning

Technical Process Review and Improvement

Operations and Efficiency Consulting
Process Review and Improvement
Throughput Analysis
Gap Analysis
Performance Metrics
Workflow Design
Lean Improvements
Visual Workplace Improvements

Auditing

GBC provides internal and external auditing services. GBC performs critical reviews of processes and associated documentation to provide results and analysis that help clients assess compliance levels and ensure applicable standards are met. GBC compliance and auditing services include:

General Auditing Services

Preparation of Audit Plan
Review and Organization of SOPs and QMS Documentation
Review of Staff Training
Review of Procedures
Documentation of Observations and Deviations
Preparation and Delivery of Audit Report
Guidance for Resolution of Observations and Deviations

Internal Auditing

Trial Master File (TMF) Audits (Clinical Studies)
Data and Database Integrity Audits
Inventory Audits (Investigational Materials, Biospecimens, Supplies, Equipment)
Technical Process Audits
Support for Certification Audit Preparedness

Clinical Site Auditing

Sponsor Protocol Compliance
Regulatory File and IRB Approval Audits
Contractual Agreement Terms
Internal Site Standard Operating Procedures (SOPs)
Compliance with Sponsor Requirements
Adverse Event (AE) Reporting

Lab and Vendor Auditing

Organizational Structure and Personnel
Ensuring Appropriate Experience and Resources
Standard Operating Procedures (SOPs)
Facilities and Equipment
Equipment Monitoring, Maintenance and Calibration Records
Data Collection and Handling Procedures

Business & Market Intelligence

GBC gathers and reports comprehensive insights and analyses for key decision points in your corporate mission. Business and market intelligence services include: