About

ABOUT US

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Experienced Clinical Research Professionals That Drive For Results.

With more than a decade of experience in the industry, Just in Time GCP works with organizations to align operations with standards of GCP and regulatory requirements.

 

WHY CHOOSE US?

Operational Excellence in Clinical Research Services.

Just in Time GCP turns your operational challenges into operational excellence. With a staff that includes clinical trials professionals and former FDA investigators, we help you ensure quality, efficiency and compliance with industry best practices and regulatory requirements.  We have helped customers in all areas of clinical research:

  • Preparing for or responding to regulatory inspections or sponsor audits
  • Establishing SOPs and Best Practices for new CROs
  • Small companies planning regulatory submission
  • Companies looking to implement or expand Quality Management Systems
  • Investigator sites looking to move into Phase I
  • Companies implementing eTMF
  • Companies  moving studies from a paper to electronic TMF

Quality assurance is a core component of successful clinical research activities.  Just in Time GCP can help you identify and resolve issues before they become problems.  If you have already received an FDA Form 483 regulatory warning letter, we can help you respond with the proper information and the corrective action plan.

what WE OFFER

1

Quality Management Systems

A Quality Management System is the cornerstone of a clinical drug development program. Just in Time GCP is the solution to all of your quality systems needs.

2

TMF Management

We help your organization harness the power of an eTMF to drive quality and ensure inspection readiness.   We offer strategies for implementing a successful eTMF system.

3

Regulatory Inspection Readiness

Just in Time GCP has extensive experience in preparing organizations for regulatory inspection.  We assist our clients in preparing for the inspection, managing the inspection, and responding to regulatory findings.

BUSINESS PLANNING

  • Guidance for Industry Electronic Source Documentation in Clinical Investigations
    FDA’s HSP/BIMO Initiative Do you have the processes in place to support these requirements?  Whether you are a sponsor or a site, this newly issued draft guidance applies to you.  This newly released guidance permits the direct documentation of data into the eCRF.  However, both the site and the sponsor...
  • Protocol Deviation vs Protocol Violation
    What is the difference between a protocol deviation and a protocol violation? In the December 2008 Compliance Program Guidance Manual or Clinical Investigator Inspections, the agency does not differentiate between a protocol deviation and violation. “A protocol deviation/violation is generally an unplanned excursion from the protocol that is not implemented...

 

Expertise You Can Count On