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 and remain competitive. However, change can be disruptive and challenging to navigate without a clear strategy in place. This is where change management comes into play—a structured approach to transitioning […]
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Understanding the Need for Change Management
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 structured approach to transitioning individuals, teams, and organizations from their current state to a desired future state. It enables employees to effectively adopt and retain change. Embracing change is […]
Highlights from Barnett International’s “Good Clinical Practice A Question & Answer Reference Guide”
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 its entirety. It is composed of a set of records held by the sponsor organization and an investigator TMF held by the investigation/institution, often called the Investigator Site File […]
Seamless Integration: Transforming CRO to Sponsor Data Transfers with JiT and fme
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 their recent unveiling of CROAssist. This collaboration is not just a merging of two entities; it’s a fusion of expertise and technology to redefine the landscape of Trial Master File […]
Just In Time GCP’s Key Takeaways from CDISC TMF Interchange
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 their informative and thoughtful comments. If you missed it, here are some key takeaways: We’re all in this together! Companies large and small are experiencing many of the same challenges within […]
Five Key Elements for a Successful Systems Implementation
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. I have been involved in the vendor selection process, acted as the sponsor/lead, served as the SME, supported migration loaders, conducted validation activities, and, naturally, used the systems as an […]
Right-sizing a Clinical Compliance Program
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 your organization’s size and business model, there are fundamental steps to help tailor your clinical compliance program effectively. Grasp the Regulatory Landscape: Begin by acquainting yourself with the relevant regulations […]
An Inspection Ready versus Inspection Prepared TMF
I am so ready for a vacation! How many of us have said that daily – ready for and desperately needing a getaway. It is easy to say we are ready for vacation, but would we be prepared for a vacation if it was offered on short notice? Being ready and excited for a vacation […]
Taking the Stress Out of Inspection Readiness
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 and contributions to study activities? Does everyone who may be called upon during an inspection know where to find information that supports the evidence of study activities? Do these questions […]
Managing the Impact of Systems Updated
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 sometimes they are required. System updates do everything from fixing bugs to offering enhanced capabilities. Often organizations go through the motions of accepting these updates without considering the implication of […]