OUR 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 experienced team has supported over 100 regulatory inspections, partnering closely with sponsors to build the right approach for each trial and ensure inspection-ready confidence.

Find The Option That Best Fits Your Needs

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

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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.

Let Us Empower You With Compliance Confidence

"Just in Time GCP's review not only improved the completeness of that study's TMF—it also strengthened documentation quality across our entire portfolio."

"The value Just in Time GCP provided through our TMF audit, is impossible to put a price on."

“We sailed through our last Health Authority inspection.”

“The business relationship has been professional, knowledgeable, cordial, and collaborative. Ideas are openly shared, honest feedback is encouraged, and conversations are both transparent and productive.”

"The Just in Time GCP team was great at following up with us, extremely professional and very accessible. I really appreciated that it was a true collaboration."

"Just in Time GCP doesn't just check the boxes—they genuinely care about our success."

“Just in Time GCP helped us identify gaps to ensure a complete study TMF. Their insights extended well beyond the initial scope and were applied across other countries, sites, and trials.”

"The people at Just in Time GCP feel like an extension of our team. I absolutely trust them."

"Just in Time GCP is flexible, dependable, and knowledgeable. The team is easy to work with and provides thorough explanations and examples of corrective actions."