Capabilities

Trial Design and Management

Comprehensive Support for Your Clinical Trial Design and Execution

Trial Design and Protocol

GBC offers clinical trial strategy and design services compliant with International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) standards.   GBC assists with developing all necessary study materials based on agreed study design and assesses the necessary operational parameters for successful execution. GBC trial strategy and design services include:

Trial Feasibility Assessment (Existing Studies)

  • Impact of Inclusion and Exclusion Criteria
  • Availability of Target Subject Population
  • Likelihood of Subject Participation
  • Projected Subject Enrollment Rates
  • Assessment of Investigator Interest
  • Compatibility with Current Standard of Care
  • Required Clinical Site Capabilities and Infrastructure
  • Required Vendor Capabilities
  • Study Logistics
  • Local and Central IRB Issues
  • Financial Considerations
  • Competing Trials

Trial Design (New Studies)

  • Study Design
    • Study Groups
    • Target Cohort Size for Biostatistical Significance
    • Inclusion and Exclusion Criteria
    • Logistical Design
  • ICH-GCP Compliant Clinical Study Protocols and Amendments
  • Model Patient Informed Consent Forms (ICFs)
  • Case Report Forms (CRFs) and Instructions
  • Clinical Trial Management Plans, including:
    • Clinical Site Development and Management Plan
    • Data Management Plan
    • Biospecimen Management Plan
    • Monitoring Plan

Clinical Site Qualification and Start Up

GBC supports clients with the identification, qualification, and approval of suitable partners including clinical sites and labs.

Pre-Trial Site Qualification and Site Qualification Visits (SQVs)

GBC utilizes study-specific qualification questionnaires to assess site strengths and weaknesses, gathering information on the local investigator, research staff, infrastructure, patient population, and IRB requirements.  GBC site qualification services include:

  • Development of Site Recruitment Questionnaires (SRQs)
  • Conducting Telephonic Site Screening Interviews
  • Reviewing Protocols with Potential Investigators and Obtaining Feedback
  • Coordination of Qualification Visit Travel
  • On-Site Qualification Visits (SQVs), Interviews, Inspections, and Audits
  • Documenting Findings in a Site Qualification Report (SQR)

Clinical Trial Agreement (CTA) Negotiation

GBC negotiates win-win contractual arrangements with study sites. Services include:

  • Development of Study Site Budgets
  • Contract Key Terms and Performance Milestones
  • Risk Sharing Models
  • Financial Negotiation
  • Final Contract Execution

IRB / EC Submissions and Approvals

GBC manages preliminary submissions, approvals, re-approvals, and tracking for local and central institutional review boards (IRBs) and ethics committee (ECs). Services include:

  • Manage Protocol Submissions, Reviews and Approvals
  • Coordinate Investigator Approvals
  • Re-Submissions and Re-Approvals
  • Manage Protocol Revisions and Amendments

Trial Master File (TMF) Management

GBC supports the management of trial documentation. Services include:

  • Preparation of Site Regulatory Binders (Standardized Formats)
  • Central Maintenance of Essential Study Documentation
  • Regular Completeness Review and Audits
  • Support for Electronic Trial Master File (eTMF) Solutions

Clinical Site Management

GBC practices adaptive study management and works with sponsors to manage study sites and logistics to meet enrollment or testing goals and timelines. GBC offers solutions to customize and streamline processes for identifying, screening, and enrolling patients. GBC clinical trial site management services include:

Management of Clinical Sites

  • Maintain Knowledge and Oversight of Clinical Site Operations
  • Develop Supportive Relationships with Principal Investigators (PIs) and Clinical Research Coordinators (CRCs)
  • Answer Specific Study Related Questions
  • Coordinate Clinical Site Feedback and Communications
  • Regularly Compile and Report Clinical Site Performance Metrics
  • Track Study Site Milestones Including First-patient-in (FPI), Last-patient-in (LPI), Last-patient-out (LPO)

Management of Specialty Labs (Central Labs)

  • Instrument Install and De-Install Services
  • Support for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

Management of Third-Party Vendors

  • Clinical Research Organizations (CROs)
  • Site Management Organizations (SMOs)
  • Contract Diagnostics Organizations (CDOs)
  • Clinical Data Management Providers
  • External Biorepository Facilities
  • Production and Manufacturing Facilities
  • Packaging Facilities
  • Supply and Logistics Vendors

Clinical Study Financial Management

  • Maintain Real-Time Financial Oversight
  • Review Invoices and Reconcile Trial Expenses
  • Track Milestone Payments
  • Track Bonuses and Incentives
  • Track Compliance Results and Overall Completeness

On-Site and Remote Monitoring

Effective monitoring is the key to high quality study data.  GBC develops efficient and risk-based monitoring plans by looking at anticipated enrollment rates and available resources across a given trial network.  GBC’s custom approaches increase trial quality and efficiency.  GBC monitoring builds confidence in partner performance while cultivating compliance and ongoing commitment.

Site Monitoring Services

GBC monitoring services involve coordination with site managers and local coordinators, a detailed on-site review of study documentation, and follow-through for resolution of observations and deviations. GBC site monitoring services include:

  • Coordination of Monitoring Visit Travel
  • Review of Enrollment Progress
  • Review of Regulatory Documents
  • Review of Relevant Source Documents (SDs)
  • Data Verification to Ensure Accuracy (Data Monitoring)
  • Review of Investigational Product and Study Supply Accountability
  • Review of Monitoring, Maintenance, and Calibration Records for Study Site Equipment and Instruments
  • Review of Site Deviations, Deviation Reports, and Deviation Logs
  • Review of Adverse Event (AE) Reports and Follow-Up
  • Documentation and Resolution of Data Discrepancies
  • Preparation and Delivery of Site Monitoring Report
  • Coordination of Regional Trial Monitors

Risk-Based Monitoring Approaches

  • Study and site specific monitoring plans
  • Predicting and preventing critical issues before they happen, not after they happen
  • Adapting the type, frequency, and intensity of monitoring to best address critical issues

Study Deviation Tracking and Resolution

GBC helps sponsors to identify noncompliance issues and implement strategies to resolve them and prevent recurrence.

Trial Master File (TMF)

  • Set up of Trial Master File (TMF) in secure, cloud-based environment compliant with industry regulations.
  • TMF structure based on custom model or the DIA reference model
  • TMF management includes set-up, routine filing, maintenance, audits, and completeness review
  • Includes provision of standardized Investigator Site Files (ISFs) a.k.a.Regulatory Binder and Data Binders as Needed

Project 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

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