How ITS Achieved 98% TMF Completeness and Cut Audit Prep Time in Half

About Integrated Therapeutic Solutions

Integrated Therapeutic Solutions (ITS) is a clinical research organization (CRO) specializing in multi-country clinical trials. As ITS expanded its sponsor portfolio and study volumes, it demanded a document management infrastructure capable of keeping pace – one that could ensure regulatory compliance, support sponsor oversight, and maintain operational control across a growing team.

ITS selected Flex Databases eTMF as the foundation for this infrastructure. The results have set a new operational benchmark. </br>

The Challenge: Manual Processes at Scale

Before adopting Flex Databases eTMF, ITS relied on a fragmented mix of spreadsheets, shared folders, and email-based workflows to manage trial documentation. As the organization grew, these approaches became a liability:

• TMF document reconciliation was slow and error-prone

• Document filing was inconsistent across teams and studies

• Audit and inspection preparation required extensive manual effort

• Sponsors had limited visibility into documentation status

• Duplicate handling and rework consumed significant staff time

• New staff required up to two weeks to onboard onto documentation processes

The cumulative cost of these inefficiencies — in time, audit risk, and sponsor confidence — made it clear that a purpose-built eTMF platform was not optional. It was essential.

The Solution: Flex Databases eTMF

ITS deployed Flex Databases eTMF across its clinical operations and quality management teams, with more than 30 users onboarded across multiple departments. The implementation was designed around four priorities:

• Centralized, standardized document management across all studies

• Automated workflows, notifications, and approval routing

• Role-based access control and complete audit trails

• Sponsor-facing collaboration tools for real-time document visibility

The platform replaced disconnected legacy processes with a single source of truth – giving ITS the infrastructure to operate at scale without sacrificing compliance or control.

Results at a Glance

98% TMF completeness (up from 75%)55% Faster audit preparation  80% Reduction in duplicate document rework4 days New user onboarding (down from 2 weeks)

Detailed Results

Operational Efficiency

The administrative burden on ITS clinical operations teams dropped substantially after implementation. Staff who previously spent significant time on manual follow-up and document chasing were freed to focus on higher-value work:

Compliance and Inspection Readiness

Regulatory compliance is non-negotiable in clinical research. Flex Databases eTMF gave ITS the visibility, traceability, and completeness controls needed to approach audits and inspections with confidence:

Sponsor Collaboration

For a CRO, sponsor confidence is a competitive differentiator. Flex Databases eTMF enabled ITS to provide sponsors with real-time visibility into study documentation, replacing slow email-based exchanges with structured, role-based access:

ITS“Flex Databases helped us standardize and simplify critical TMF processes across departments. We significantly reduced manual work, improved audit readiness, and strengthened collaboration with sponsors. The centralized environment gave teams much better visibility and control over daily operations.”

Looking Ahead: Scaling Into Post-Marketing PV

As ITS’s sponsor portfolio and study volumes continue to grow, the same operational discipline that delivered these eTMF results — process standardization, complete audit trails, and rigorous quality control — gives ITS the capacity to take on a significantly higher volume of cases and projects with efficiency and confidence in the quality of an expanded workflow.

Building on this foundation, ITS is actively expanding into post-marketing pharmacovigilance, extending the operational rigor established through its eTMF and clinical trial PV experience. As part of this expansion, Flex Databases Pharmacovigilance is being configured to support ICH E6(R3) compliant safety reporting, including direct regulatory submission pathways to agencies such as the FDA — capabilities expected to be fully operational in the near term.

This positions ITS as an emerging post-marketing PV partner, backed by the same established, full-service pre-marketing drug safety infrastructure that has defined its operational track record.

Conclusion

ITS built its documentation infrastructure with Flex Databases eTMF and the results speak directly to what clinical research organizations need most: efficiency, compliance, and sponsor trust.

With TMF completeness at 98%, audit preparation time cut in half, and sponsor response times dramatically reduced, ITS has established the operational foundation to take on more studies, more sponsors, and more complex trials without the risk that comes from fragmented, manual document management.

Flex Databases eTMF is the platform that made it possible.