Donna Dorozinsky, President & CEO
As clinical trials remain essential for the development of new treatments, the need for complying with the principles of Good Clinical Practice (GCP) and maintaining a high-quality compliant Trial Master File (TMF) remains a huge burden on some of the small and young pharma enterprises. Once these organizations reach the stage of submitting their New Drug Application (NDAs) and Biologics License Application (BLA), they often tend to get entrapped into a maze of process analysis to get their drug approved. Hence, they rely on external business partners to identify the risk factors for potential gaps that may impact their TMF. Addressing this need, Just in Time GCP, an expert in clinical research operations and consulting, brings to the table a wealth of experience in the business. “We combine our extensive clinical compliance with a deep understanding of clinical drug development and provide our clients with the best-in-class services,” says Donna Dorozinsky, President and CEO of Just in Time GCP. The company helps its clients bring treatment to patients by ensuring their people, process, and technology are aligned with organizational goals, GCP compliance, and inspection readiness.
Just in Time GCP begins each of many of their client engagements with a gap assessment that evaluates if the client organization has the right people, processes, and technology to achieve their short and long-term goals. If there are gaps in clients’ technology resources, the company helps the client identify the right vendor and assists the client in implementing the technology and associated business processes in a validated and compliant manner. In addition, Just in Time GCP offers managed services to maintain clinical systems and guide them on its usage and ongoing updates.
For example, if the client implements an electronic trial master file (eTMF), Just in Time GCP assists the client in identifying the vendors, establishing the criteria for selecting the vendor, performing validation, and supporting the client in building the processes that will allow them to leverage the complete functionality of that system. Post-implementation, the company can provide services for setting up the eTMF for studies and further managing the eTMF records over the long term. Just in Time GCP also provides TMF management services, where it collaborates with the clients’ study team members and ensures that their TMF is in a state of inspection readiness through-out the life of the study. The TMF team can either provide ad hoc support or fully integrate into the study team providing records quality checks, completeness reviews and day to day management of the TMF.
We combine our extensive clinical compliance knowledge with a deep understanding of clinical drug development and provide our clients with the best-in-class services
This includes supporting organization in oversight of TMFs that are managed by CRO partners. As the client prepares for a potential regulatory inspection, the Just in Time GCP team helps the client ensure that they are inspection prepared and fully understand the story of their study.
Donna demonstrates the effectiveness of these services through a client success story. When Just in Time GCP partnered with this client, they had selected an eTMF technology but did not have the people or processes internally to manage that technology. The system had not been validated in their operating environment, and there was a delay in moving the records to an approved state within the eTMF. Just in Time GCP helped them optimize the technology to meet their current business needs, perform a risk based retrospective validation and develop the business processes that ensured that they used the system at its full capability. Benefitting from these services, the client maintained a long-term relationship with Just in Time GCP for managing the business side of the system and the ongoing day to day management of the TMF.
The true differentiating factors for Just in Time GCP have been the depth of experience, internal process, standards, and commitment to quality it employs while working with clients. The company has collaborative partnerships with several technology vendors, which allows them to help their clients more effectively. Donna remarks, “We have four pillars of leadership defined as collaboration, composure, quality, and balance. We bring these four pillars to the work that we do with our clients.” This statement is further strengthened by the fact that Just in Time GCP works not just with its clients but also their partners, technology vendors, and CROs to help bring products that support the patients’ needs.
Being predominantly a virtual company, Just in Time GCP has continued its work even during the COVID-19 pandemic with over 60 employees spread across the United States. “We adapted to this environment quickly, and we were also able to coach our clients as they adjusted to this new way of working,” remarks Donna. Just in Time GCP had to be agile and pull teams together to get the resources and guide the client organizations’ newfound resourcing needs. The company has had the opportunity to have supported clients in virtual regulatory inspections, helping their clients shift to a new interaction model with Health Authorities globally.
In the post-COVID times, Just in Time GCP is working to create a broader presence as a business and technology consulting company that is supported by a robust services capability. The company continues to expand its consulting services capabilities, in order to better serve the industry during a time of digital transformation, both in terms of business process and technology maturation.