Services

Services overview

Building a Quality Management System

Our consultants are experts in GCP compliance. We work with organization to implement a quality management system that ensures a quality clinical trial.  The Trial Master File (TMF) is a collection of documentation that demonstrates the trial was conducted to the study plan and in compliance with GCP.  A poorly managed TMF puts an organization at risk during a regulatory inspection.  Just in Time GCP works with your team to ensure inspection readiness.

 

We can assist you with:

  • Implementing Quality Management Systems
  • Strategies for Ensuring a Quality TMF
  • Systems Gap Analysis
  • Site Management Needs
  • Response to Audit/Regulatory Findings
  • GCP Training
  • SOP Implementation
  • GCP Training
  • GAP Analysis
  • Protocol Implementation Strategies

 

Main Services

  • Procedural Documents
  • GCP Training
  • Quality Control Activities
  • Quality Assurance Activities
  • CAPA Management
  • Application of DIA Reference Model
  • Mapping
  • TMF Management
  • TMF Quality Control Support Services
  • TMF Procedural Documents
  • eTMF Vendor Selection

  • TMF Audits
  • Investigator Site Audits
  • CRO Audits
  • Vendor Audits (including 21 CFR Part 11)
  • Job Descriptions
  • Staff Orientation
  • Preparation of Study Budgets
  • Standard Operating Procedures
  • Implementation of Formal Training Program
  • Implementation of Community-based Clinical Research Program
  • Team Meeting Facilitation
  • Quality Assurance Services
  • CPU Operations
  • Inspection Readiness
  • Process Mapping
  • Standard Operating Procedures – Clinical, Data Management,
  • Statistics, Quality, Clinical Supplies, Project Management, Regulatory Affairs
  • Forms Development
  • Staff Training
  • Pre-Approval Inspection Readiness
  • TMF Management
  • Mock Inspections
  • TMF Audit
  • Response to FDA 483 and Warning Letters
  • Overview of Good Clinical Practice
  • Role of the Investigator
  • Human Subject Protection
  • An Overview of the Drug Development Process
  • Documentation of Adverse Events
  • Source Documentation
  • Quality Management
  • Electronic Data Collection and Validation
  • Developing and Writing Standard Operating Procedures
  • Study Coordinator
  • Orientation Programs

We provide training for all aspects of your clinical research operation. Programs can be customized to your organizational processes. Contact us to see how Just in Time GCP can help get the most out of your people!

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Other services

Consulting

Our staff of professionals includes industry experts with many years of experience in both site and sponsor organization, as well as ex-FDA inspectors. We are available to help you with simple questions or complex problems such as responding to FDA Form 483 and Warning Letters. We provide timely advice and answers to your questions. In addition our staff is available for compliance audits or inspection readiness assessments.

Sample Procedural Documents

  • Compliance with Standards of GCP
  • Management of Standard Operating Procedures
  • Obtaining Informed Consent
  • Drug Accountability
  • Management of Adverse Events
  • Managing Source Documents
  • Obtaining Past Medical History
  • Physical Examination
  • Managing Data Discrepancies
  • Advertising
  • Investigator Responsibilities
  • Equipment Maintenance
  • Monitoring Freezer Temperature – Manually
  • Monitoring Freezer Temperature – Temperature Wheel
  • IRB Communications
  • Measuring Biometrics
  • Measuring Vital Signs
  • Screening and Approval of Subjects for Study Participation
  • General Screening
  • Sample Collection – Includes procedure for both blood and urine sample collection at a single timepoint

 

Training

We provide training for many aspects of your operation. Programs can be customized to your organizational processes. Contact us to see how we’ve provided this servcice for others and how Just In Time GCP can help get the most out of your people!

  • Overview of Good Clinical Practice
  • Role of the Investigator
  • Human Subject Protection
  • An Overview of the Drug Development Process
  • Documentation of Adverse Events
  • Source Documentation
  • Quality Management
  • Electronic Data Collection and Validation
  • Developing and Writing Standard Operating Procedures
  • Study Coordinator Orientation Programs

Trial Master File Services

  • TMF Plan
  • Contract Ongoing TMF Quality Control Review
  • TMF Audit
  • Vendor Selection
  • eTMF Systems Implementation

 

Contact Us.
We Can help.

215-343-4484
info@justintimegcp.com

If your clinical research operations face challenges, you’ve found a specialized resource to assist your development of a more efficient and effective operation.