News, Articles, Events

Just in Time GCP is thrilled to announce the appointment of Aaron Grant as the new Head of Innovation, a newly created position designed to

  The Just in Time GCP Team At Just in Time GCP (JiT), our team members are integral to our mission of delivering top-tier GCP

Insights from the 2024 Veeva R&D Summit Last week the Just in Time GCP team attended the Veeva R&D Summit in Boston where we proudly

“Processes and Practices Applicable to Bioresearch Monitoring Inspections: Guidance for Industry” is a draft guidance document issued by the FDA in June of this year.

Just in Time GCP is proud to announce its inclusion on the 2024 Inc. 5000 list, marking the fourth consecutive year the company has been

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical

To effectively manage the Trial Master File (TMF), it is essential to track and monitor key metrics or Key Performance Indicators (KPIs) that measure the

Artificial Intelligence (AI) has been making significant strides across various industries, and clinical operations are no exception. The integration of AI technologies is transforming how

In the realm of clinical trials, maintaining comprehensive and accurate documentation is not just a regulatory requirement but a cornerstone of ethical and effective research.

The Trial Master File (TMF) is a collection of essential documents that tells the story of a clinical trial and provides evidence that the study

Navigating Good Clinical Practice Compliance in Clinical Trials In the realm of clinical trials, ensuring the safety, rights, and well-being of participants is paramount. This

There are different types of quality checks performed on TMF content.  Uploaders should perform a record quality check prior to uploading a record.  Records should

Ensuring Good Clinical Practice (GCP) compliance is paramount for any organization involved in clinical trials. It ensures the safety, rights, and well-being of trial participants

In the dynamic landscape of clinical trials, innovation isn’t just a buzzword; it’s the cornerstone of progress. It can be difficult to identify where to

CDISC EU Interchange 2024 has concluded and this year we were offered a treasure trove of insights and innovations. The TMF Reference Model’s inclusion in

We have established throughout this blog series that change is inevitable in any organization. Whether it’s implementing new technology, restructuring processes, or adapting to market

Throughout this series we have established that change is inevitable in any organization striving for growth and adaptation. However, with change comes resistance, often stemming

Considerations in acquisitions of pharma and biotech organizations and their assets are multifaceted and involve various factors, including financial, strategic, regulatory, and operational aspects. One

Change is inevitable, especially in today’s fast-paced and dynamic world. Whether it’s implementing new technology or restructuring processes, organizations must effectively manage change to thrive

In the clinical trial landscape, where innovation and adaptation are paramount, understanding the need for change management is crucial for success. Change management is a

What is a Trial Master File (TMF)? The Trial Master File is a standalone collection of records that tells the story of the clinical trial

In the dynamic realm of clinical research, the partnership between Just in Time GCP (JiT) and fme emerges as a beacon of innovation, particularly with

What an amazing few days of learning and collaboration during the inaugural CDISC TMF Interchange last week.  Special thanks to the speakers and panelists for

Five Key Elements for a Successful Systems Implementation  Over the past two years at JiT, I have contributed to numerous system implementations in various capacities.

Navigating the intricacies of clinical compliance in a small pharmaceutical or biotech company demands meticulous planning and strategic thinking. Although the particulars vary based on

I am so ready for a vacation! How many of us have said that daily – ready for and desperately needing a getaway. It is

Have you ever thought about how your team may interact with a regulator? Is your team prepared to speak about study events, including their responsibilities

Managing the Impact of eClinical System Updates Many of us use cloud-based clinical systems that regularly release system updates.  Sometimes these are optional updates and

We hear so much about organizations having an inspection ready TMF at all times; but is an inspection ready TMF truly enough?  An inspection ready