Just in Time GCP
Enabling Holistic Gcp Inspection Readiness

Drawing insights from more than two decades of experience, Just in Time GCP has evolved into a sought-after partner for GCP compliance and Trial Master Files (TMF) management. Today, the company has become an industry expert and has earned its spot as one of the fastest-growing businesses in areas of clinical compliance, inspection readiness, and content management services.

When it comes to preparing for a regulatory inspection, organizations with poorly maintained documents and undocumented processes often find themselves in unfavorable circumstances. Such unpreparedness results in delays or non-approval during clinical trials. Moreover, many companies are currently developing assets with minimal sponsor resources and partnering with multiple vendor organizations. Even if services are extensively outsourced to vendors, sponsors are still accountable during the clinical trial. Be it conducting quality research or managing an asset, sponsor oversight is a crucial element. This, combined with staff turnover at the sponsor level, makes inspection preparation challenging for many companies in this space. To this end, Just In Time GCP helps companies prepare for and manage the inspection. “Driven by the passion for helping organizations adhere to GCP compliance and inspection readiness, we can turn operational challenges into operations excellence,” says Denna Dorozinsky, President and CEO of Just in Time GCP.

The firm offers expertise in implementation of Quality Management Systems, Systems Gap Analysis, TMF Management, Site Management, Response to Audit/ Regulatory Findings, GCP Training, Implementation of SOP, and Protocol Implementation Strategies.

With quality and subject safety as the cornerstone, Just In Time GCP works with clients to develop processes and prepare supporting procedural documents for QMS. The company also has many experienced auditors performing vendor and site audits to identify potential risks in client organizations. In addition, the company offers general GCP training and study-specific training, which are customized to meet clients’ unique requirements. As a trusted partner, Just In Time GCP helps clients leverage the true value of an eTMF to ensure inspection readiness. The company offers several proven strategies for a successful eTMF implementation program. They can implement new systems, helps client migrate from one system to another, and remediate a current system. Just In Time GCP can identify and configure the system to suit clients’ business needs. They can also implement an ‘out of the box’ system that assists clients in the validation and product development processes.

“Our team can conduct a GCP audit of the TMF, review business processes, inspect TMF, interview staff members, or visit a site for a site assessment,“ says Denna.

The company also has an in-house clinical operations team that collaborates with sponsors to develop and implement existing processes, identify gaps, and recommend new methods or optimize current ones. These practices ensure that vendor expectations are fulfilled while maintaining sponsor oversight during a trial.

Holding over 100 years of combined experience, Just in Time GCP has a strong pedigree of catering to small, medium, and large pharma and biotech organizations. The company has several clients that have collaborated with them for more than ten years. Tying back to its core values of Quality, Collaboration, Composure, and Balance, they have uniquely positioned itself as the ideal partner for compliance, process excellence, and inspection readiness. In essence, Just in Time GCP delivers a balance of clinical, GCP, & records management to client organizations.