We strive to be your trusted resource for all things clinical compliance.
Below is a selection of recent articles, and you can explore more in our eNewsletter, The GCP Compass.
Reclaiming Your Trial Master File: A Strategic Move Toward Stronger Clinical Compliance As clinical trial complexity grows and regulatory expectations continue to evolve—particularly with the release of ICH E6(R3)—more sponsors are rethinking how their Trial
Just in Time GCP to Present at CDISC + TMF Europe Interchange 2025 We’re excited to announce that Just in Time GCP will be participating in the CDISC + TMF Europe Interchange, taking place May
Proactive GCP Compliance: Insurance for Your Clinical Trial In the world of clinical trials, compliance with Good Clinical Practice (GCP) is often seen as just another regulatory requirement—something to check off a list to satisfy
Tina Henderson Joins Just in Time GCP to Lead Life Sciences Consulting Just in Time GCP continues to grow, and we are excited to welcome Tina Henderson, RN, MBA, MS, CCRA, CCRC, as the new
Implementing Risk-Based Quality Management: Insights from the Latest GCP Guide The 2024/2025 edition of Barnett’s Good Clinical Practice (GCP) A Question & Answer Reference Guide is a comprehensive resource on clinical compliance, featuring over 500
George Lyon Joins Just in Time GCP to Drive Commercial Growth Just in Time GCP is experiencing rapid expansion, and to sustain our momentum, we welcome George Lyon as our Chief Commercial Officer. With over
Why the CDISC TMF Reference Model is Important for Smaller Companies Executing Clinical Trials If you’re a small or emerging life sciences company, navigating the complexities of clinical trials can be daunting. A key element
ICH E6(R3) Finalization – An Action Plan for Clinical Compliance Critical Impacts of ICH E6 (R3) and Business Process Updates for Clinical Trial Sponsors The release of ICH E6 (R3) ushers in a new era
Hidden TMF Clinical Compliance Risks The Risk Of Inspectable Content Housed Outside the TMF In the fast-paced world of clinical trial compliance, maintaining a robust and compliant Trial Master File (TMF) is essential for inspection
20 Years of Delivering Clinical Compliance Confidence Founded in 2005, Just in Time GCP has empowered our partners with clinical compliance confidence for over 20 years. We align people, processes, and technologies with Good Clinical
How Generative AI is Transforming GCP Inspection Readiness Just in Time GCP’s Founder and CEO, Donna Dorozinsky, contributed a guest column for Clinical Leader outlining the impact of generative AI on GCP inspection and clinical
Clinical Trial Master File Trends from 2024 As we approach 2025, the Clinical Trial Master File (TMF) landscape is undergoing substantial transformations driven by technological advancements and evolving regulatory requirements. At Just in Time GCP,
Just in Time GCP Welcomes George Lyon as Chief Commercial Officer Just in Time GCP is excited to announce the appointment of George Lyon as our new Chief Commercial Officer. “Excited to welcome George
Generative AI: Innovating Inspection Readiness and TMF Quality As your partner in clinical trials, we at Just in Time GCP understand the challenges of maintaining inspection readiness, especially regarding the quality and completeness of Trial
Ensuring Your Operations Support Your Trial’s Scope Moderating a recent roundtable discussion on clinical process assessment has highlighted a growing gap between current clinical process capabilities and the requirements needed to execute complex studies. A
The Importance of TMF Management in Clinical Quality Just in Time GCP’s Founder and CEO, Donna Dorozinsky, shared her expertise in a recent article in The Clinical Trial Vanguard titled The Trial Master File: A
Just In Time GCP: Recognized for Impact and Innovation in Clinical Research Just In Time GCP is excited to announce our recognition as #9 on the Philadelphia Business Journal’s 2024 Largest Women-Owned Businesses in Greater
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 drive change within the clinical research industry. With a strong
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 compliance and clinical research consulting services. This month, we’re shining the
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 served as a Gold Sponsor. Veeva Summit was an exciting
“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. The intent is to provide clarity on the procedures and
Just in Time GCP, a company focused on enhancing the quality of clinical trials, 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 trials. It serves to protect the rights, integrity, and confidentiality
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 completeness, timeliness, accuracy, accessibility, and compliance of the TMF with
