CLINICAL COMPLIANCE SERVICES
Clinical Compliance Confidence
Your path forward.
At Just in Time GCP, we deliver tailored clinical compliance solutions designed around your study’s unique needs. Our team of 100+ full-time experts brings deep experience across 100+ regulatory inspections, working closely with you to build the right approach for your trial.
Find The Option That Best Fits Your Needs
- Inspection-Ready Confidence
- Trial Master File (TMF) Assessment, Management, & Remediation
- Roadmap to GCP Compliance
- Clinical System Implementation and Optimization
Inspection-Ready Confidence
Gap Assessment
Identify gaps between procedural documents, study documents and the study team’s understanding of the narrative
- Review of Documentation Supporting Trial Conducts Identification of GCP Compliance Gaps
- Identification of Inconsistencies between Study Plans/Procedural Documents, TMF Content, and Study Team Narrative
Story of the Study
Review of eTMF documentation to understand the story that the TMF tells
- Evaluation of Documentation and What it Says about the Overall Study
- Identify any GCP Inspection Risks
- Develop a Plan for Inspection Readiness Activities
Inspection, Preparation, and Readiness
Mitigate inspection risks at the sponsor, partner, and site levels
- Storyboarding
- Outline Inspection Strategy
- Execute Mock Inspections
- Study Team Inspection Preparation
- Site Inspection Preparation
Trial Master File (TMF)
Assessment, Management,
& Remediation
eTMF Health Assessment
High-level assessment of the study specific TMF to identify gaps
- High-Level Review with Risk Analysis
- Focused on Timeliness, Completeness and Quality
- Understand Current Risks and Gaps
- Report of Observations and Recommendations
TMF Management & Oversight
Day-to-day management of the TMF, record processing, ensuring partner deliverables, process mapping, and reporting metrics for ongoing compliance confidence
- General Oversight of the eTMF
- Record Upload, Classification, and Quality Check
- Strategic Oversight Plan and Execution to Ensure Completeness
- TMF Plans/Indexes/Maps
- Metrics and Reporting
TMF Remediation
Missing document reconciliation, and proactive risk mitigation of the TMF
- Metadata Updates
- Missing Document Reconciliation of Shared Drive Content
- General TMF Cleanup
TMF Functional Service Provider
(FSP) Capabilities
Outsource the entire TMF management function for complete compliance confidence
- Individual Study TMF Management
- SME to Support Study Team
- Ongoing TMF Quality Management
Roadmap to GCP Compliance
GCP Gap Assessment
Evaluate the alignment of your study processes with your outsourcing strategy and regulatory requirements
- Quality Management System Assessments and Optimization with Supporting SOP Authoring
- GCP Audits and Strategic Audit Planning
eClinical System Current State/Future State
Define the ideal state of compliance for your eClinical systems and develop a strategic roadmap with supported implementation
- Evaluation of System Functionality and Process Capability
- Comparative Assessment of Current to Ideal Future State
- Detailed Roadmap of Actions to Future State
- Comprehensive Support for Implementation and Remediation
Change Management
Leverage effective change management to optimize the use of available resources and streamline compliance efforts
- Tailored Framework for Managing the Human Aspects of System/Process Implementation to Enhance Adoption and Sustain Change
- Bridge Gap Between Projects Solutions and Results
- Right-Sized Communication and Training Plans
eClinical System Implementation and Optimization
System Implementation
Deploy a right-sized team to support systems function from setup to ongoing release management with our Bridge Program
- System Selection Criteria and Execution
- Strategic Implementation Plan with Change Management
- Content Migration
Accessibility
Develop, execute, and review a logical user account strategy with ongoing review
- User Account Management
- Period Review of System Access
- Global Directory Management
Business Systems Administration
Configure systems to study needs and requirements and provide user training and support
- Study Configuration
- Level-1 End-User Support
- Training Maintenance
- Ad-Hoc Systems Reports and Dashboards
System Release Strategy
Strategize system updates and improvements with study timelines and resource availability
- Assessment of New Features for Business Value of Study
- Business Release Planning and Updates
- Risk/Benefit Assessments for Continual Improvements
- Change Control and Validation
Validation/Risk Assessment
Confirm systems meet their intended purposes and function appropriately in a regulated environment
- System Risk Assessments
- System Release Validation Support
Not Sure What You Need
Try Our Custom Solutions
If you’re not sure exactly what you need, we can customize a solution to fit your needs, budget and timeline. With our MANAGED SERVICES offering, pick and choose exactly what you want without the commitments of a big contract. Choose a fixed number of hours and we’ll work with you to determine the scope that best helps you accomplish your goals.
In-Demand Projects
eTMF Story of the Study
We’ll conduct a targeted review of TMF documentation to identify inconsistencies between the study plan requirements and TMF content, gaps against relevant Study Plans, SOPs, regulations, and best practices, as well as any systemic gaps or potential risk areas. You’ll receive a comprehensive report outlining identified issues along with actionable recommendations, giving you the confidence and peace of mind that your TMF is compliant and inspection-ready.
eClinical System Optimization
We’ll assess your current eClinical systems to define an ideal future state for compliance. From there, we’ll develop a strategic plan to bridge the gap, including a comprehensive analysis of current system functionality and process capabilities, a comparative assessment of the current state versus the desired future state, a detailed action roadmap to achieve compliance, and dedicated support for implementation and remediation.
GCP Gap Assessment
We’ll conduct a focused review of study procedural documents, related materials, and operational workflows to assess your current GCP operating environment. This includes a high-level evaluation of TMF content and benchmarking the review against regulations and industry best practices. You’ll receive a prioritized list of compliance and efficiency gaps, along with actionable remediation recommendations. With our expertise, we know where to look and what to look for—helping you address smaller issues now before they escalate into costly challenges later.
Let Us Empower You With Confidence
GCP Inspection Ready. Set. Go.
