Ramsay Health Care: Strengthening control and compliance for clinical trial records

The background

Ramsay Health Care is a leading private healthcare provider operating hospitals, clinics and healthcare services across Australia, the United Kingdom and Europe.

At Lake Macquarie Private Hospital (LMPH), the Clinical Trials and Research team manages clinical trial material and data that must be securely retained to meet regulatory requirements.

The hospital was already an existing Grace Information Management customer, providing an opportunity to establish a dedicated sub-account for the Clinical Trials and Research department and give the team greater control over its archived records.

Clinical trial records have specific archiving and retention requirements, making visibility and control over their lifecycle particularly important.

Previously, the department’s clinical trial records were archived alongside other hospital records. This meant the team had limited oversight of when its records were scheduled for destruction, creating concerns around the potential loss of information that still needed to be retained.

The department needed a solution that could:

  • Securely archive clinical trial material and data offsite.
  • Support regulatory archiving requirements.
  • Give the Clinical Trials and Research team greater control over its own inventory.
  • Reduce the risk of clinical trial records being destroyed prematurely.
  • Provide reliable retrieval when archived cartons were required.

As LMPH already had an established relationship with Grace, Grace worked with the Clinical Trials and Research team to create a dedicated sub-account for its clinical trial records.

The solution includes:

  • Secure offsite carton archiving for clinical trial material and data.
  • A dedicated sub-account providing greater separation and oversight of the department’s inventory.
  • Improved control over the management and lifecycle of archived clinical trial records.
  • Timely retrieval and delivery of cartons when required.
  • Support from Grace throughout the establishment of the new account structure.
  • Internal delegations within the department to maintain and manage its Grace inventory.

This provided the department with a more structured approach to managing clinical trial records while continuing to use Grace’s existing relationship with the hospital.

The dedicated sub-account has given the Clinical Trials and Research team increased control over its inventory held with Grace.

While the department is not yet in a position to quantify specific outcomes, the new approach has delivered important improvements, including:

  • Greater oversight of archived clinical trial material.
  • Increased control over the department’s records inventory.
  • Reduced risk associated with the destruction of clinical trial records.
  • A clearer internal process for managing archived records.
  • Timely delivery when cartons are recalled.
  • Minimal wait times when accessing inventory.
  • Greater confidence in meeting regulatory archiving requirements.

The project has also led to clearer internal delegations, establishing responsibility within the department for maintaining its Grace inventory.

As an existing Grace customer, continuing the relationship was a straightforward decision for LMPH. Fiona highlights the knowledge and helpful approach of the Grace team during the establishment of the Clinical Trials and Research sub-account as providing further confidence in the solution.

Communication throughout the process was described as efficient and friendly, with the team satisfied with the service and expertise provided.

“We now have increased control over our inventory held with Grace. The Grace team was helpful, and communication was efficient and friendly. We have been satisfied with the service and expertise offered by Grace, and delivery of recalled boxes has occurred in a timely manner when requested, with minimal wait times for inventory.”

Fiona Schwetz, Assistant Clinical Trials & Research Manager, Ramsay Health Care

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