Supporting Clinical Trial Compliance

CLINICAL RESEARCH COMPLIANCE

The regulatory environment

Clinical research in Australia operates within one of the world’s more rigorous regulatory environments, particularly in relation to the management, retention, and protection of trial data. For organisations such as CSCRI, historically focused on gastroenterology research including inflammatory bowel disease and Crohn’s disease, compliance begins with strict adherence to both international and national frameworks governing clinical documentation.

These obligations stem chiefly from the International Council for Harmonisation’s Good Clinical Practice (ICH‑GCP) guidelines, which the Therapeutic Goods Administration (TGA) adopts in Australia. They are further supported by the Australian Clinical Trial Handbook and the National Health and Medical Research Council’s codes for responsible research conduct.

| Under these frameworks, organisations must retain clinical trial records for at least fifteen years for adult studies. When a trial includes paediatric participants, the retention period increases to twenty‑five years. The operational implications of those requirements are substantial, particularly for organisations managing multiple concurrent studies over extended periods of time.

THE CHALLENGE

Managing large volumes of clinical trial documentation

The scale of documentation generated during a clinical trial is difficult to appreciate without understanding the lifecycle of the research itself. Early-stage studies, particularly Phase 1 and Phase 2 trials, are typically focused on establishing safety profiles and evaluating preliminary efficacy within comparatively small participant groups.

Often running for several years and involving hundreds or thousands of participants, Phase 3 trials require a de-identified participant file to be maintained for every individual enrolled in the study. These records include signed consent forms, visit documentation, treatment records, and supporting medical information. In many cases, paper-based source documentation is also retained independently by the research organisation.

Alongside participant records sit the administrative and operational materials required to govern the study itself, including Investigator Site Files, study protocols, pharmacy manuals, laboratory manuals, ethics correspondence, and ongoing amendments requiring committee review and re-approval. Collectively, the result is a substantial and continuously expanding body of information requiring secure, structured, and highly disciplined management.

| While early phase studies typically involve smaller participant groups, Phase 3 trials create significantly greater information management complexity. These studies can run for several years and involve thousands of participants across multiple locations.

OPERATIONAL AND ENVIRONMENTAL RISKS

Protecting critical records in regional Queensland

For the Mackay-based team, the challenges extended beyond document volume alone. Located in a region vulnerable to cyclones and flooding, the organisation faced ongoing concerns around the physical protection of original paper records. The potential impact of severe weather events introduced additional operational risk to already complex archive management requirements.

At the same time, the organisation needed confidence that archived records could be retrieved quickly if required.

Whilst urgent retrieval requests are relatively uncommon in clinical research, rapid access can become critical if adverse drug reactions emerge following wider treatment use. In these situations, clinical teams must be able to access participant records without delay.

| Maintaining secure storage alongside reliable retrieval capability was therefore essential.

THE SOLUTION

Accredited information management with TIMG

TIMG provided a secure and accredited information management solution designed to support the long-term compliance requirements of clinical research organisations.

A dedicated TIMG account manager oversaw the onboarding process, coordinating quoting, collection and transportation while maintaining strict chain‑of‑custody controls throughout the transition. TIMG then securely moved the records into a professionally managed facility, giving the organisation confidence that its sensitive clinical trial documentation would stay protected, accessible and compliant for the entire retention lifecycle.

| By partnering with TIMG, CSCRI was able to move from a position of logistical concern to one of operational confidence.

ONLINE DOCUMENT MANAGEMENT

Improving archive visibility with Coalesce™

To support ongoing archive management and retrieval, the clinical team was onboarded to Coalesce™, TIMG’s proprietary asset management, reporting and billing platform.

Designed to support the operational realities of clinical trial management, Coalesce™ provided staff with:

• full visibility across archived holdings
• efficient retrieval request management
• searchable archive records
• streamlined reporting capabilities
• greater control across multiple studies and sponsors

The platform allowed e-files and supplementary documentation to be attached to physical box records, helping create a more unified and searchable archive environment across both physical and digital records.

| As archive complexity increased across hundreds of boxes, sponsors and compounds, Coalesce™ enabled staff to locate specific records quickly using targeted search filters rather than manually navigating physical archives.

THE OUTCOME

Supporting long-term clinical trial compliance and operational confidence

The value of the partnership with TIMG became particularly evident as CSCRI prepared to wind down operations. TIMG worked closely with the organisation to ensure sponsors could continue securely accessing archived records while maintaining ongoing compliance obligations throughout the transition period.

This flexibility reflected TIMG’s practical understanding of the clinical research environment and reinforced its role as a trusted information management partner rather than simply a storage provider.

Most importantly, the organisation gained peace of mind knowing its research records remained protected within a secure, accredited and professionally managed environment designed to support long-term compliance requirements.

| By removing the burden of managing large-scale physical archives internally, the clinical team was able to remain focused on research delivery and participant outcomes.

INFORMATION COMPLIANCE

Why accredited information management matters in clinical research

Effective information management is fundamental to the integrity and continuity of clinical research.

Secure storage, compliant retention practices and reliable retrieval processes all play an essential role in supporting:

• clinical trial compliance
• participant safety
• audit readiness
• research integrity
• long-term accessibility of clinical data

| This case study demonstrates how the right information management partner can help clinical trial organisations reduce operational risk while maintaining confidence in the protection and accessibility of critical research records.