Product/Service

GCP Compliance

Source: NextDocs Corporation

The FDA continues to increase the number of investigator audits performed each year, with over 700 audits conducted per year in recent years.

The FDA continues to increase the number of investigator audits performed each year, with over 700 audits conducted per year in recent years. Clinical audits result in the identification of violations in up to 59% of inspections for some sponsors.

Penalties for not following the law include insubmissability of data, punitive actions, and of course patient risk which can result in fines and litigation.

NextDocs solutions can help substantially with GCP Compliance. For example, here’s how our Clinical Solution can help you to avoid the most common findings recently reported by all FDA centers:

Issue NextDocs Solution
Failure to follow the investigational plan Of course, ensuring adherence to the investigational plan requires scientific and regulatory expertise. However, the NextDocs solution focuses on collaboration between the investigator and the sponsor so that all parties are working from the same set of documentation and are alerted to new documents and updates in real time.
Inadequate or unavailable records NextDocs enables the CRA to monitor the trial master file remotely. Automation can alert the sponsor to missing required document or delays in completing documents. Processes shipment of the investigational product that depend on confirming the availability of complete sets of prerequisite documents can be automatically initiated by NextDocs.
Inadequate informed consent / documentation The NextDocs model allows informed consent documents to be created at the study, country or site level. Documents are tracked to approval, distributed to investigators, and IRB approvals tracked within the system.
IRB notification / approval issues IRB notifications and approvals are uploaded to the trial site so that they can be confirmed as part of trial monitoring. The system accommodates central, country, or site-specific IRBs and IECs.
Lack of appropriate delegation / investigator oversight Although nothing can replace the human element in competent oversight, the NextDocs clinical solution automates notifications and checks around standard trial start-up, conduct and close-out activities so that oversight can focus in
Adverse event reporting issues The NextDocs clinical solution includes a module for safety report distribution in accordance with local authority requirements.