Global CRO sets high standards for clinical documentation

Company background

A renowned Contract Research Organization (CRO), with a rich history of supporting the pharmaceutical, biotechnology, and medical device industries, has evolved into a global leader in providing essential products and services to expedite drug discovery, development, and the approval processes.

Challenges and risks with manual document processes

Despite its impressive capabilities and contributions to the pharmaceutical industry, the company faced significant challenges related to document management. The company’s vast and geographically dispersed operations resulted in extreme system fragmentation, leading to data and document inconsistencies. With multiple disconnected document management and publishing platforms across its 100+ locations, the company struggled to maintain uniformity and accuracy in its clinical documentation.

These inconsistencies posed several risks:

1. Regulatory Non-compliance: Ensuring compliance with stringent regulatory standards is critical in the pharmaceutical industry. Fragmented systems and inconsistent documentation practices could lead to non-compliance, jeopardizing the approval of new drugs and therapies.
2. Operational Inefficiencies: The lack of a unified document management system created inefficiencies in document retrieval, review, and approval processes. This delayed project timelines and increased the operational burden on their clinical operations team.
3. Quality Control Issues: Maintaining the highest quality of clinical documentation is essential for building and retaining trust with sponsors and regulatory bodies. Document inconsistencies risked compromising the quality and reliability of the company's deliverables.
4. Scalability Challenges: As the company continued to expand its operations and take on more clinical trials, the existing fragmented systems hindered scalability. The company needed a solution that could support growth without necessitating a proportional increase in the clinical operations workforce.

Incorporating M-Files and Adlib for critical workflow automation

The company embarked on a strategic initiative to consolidate its internal systems and standardize its document management processes. The company transitioned to M-Files, a robust global document management solution designed to streamline document-centric processes and improve overall efficiency.

Recognizing the need for a comprehensive solution to ensure clinical documents comply with regulatory standards, the company integrated Adlib into its M-Files environment. Adlib specializes in document transformation and workflow automation, making it an ideal partner for the company's needs. This integration provided several key benefits:

1. Automated Compliance: Adlib's advanced automation capabilities ensured that all clinical documents were automatically processed and formatted to meet regulatory requirements. This significantly reduced the risk of non-compliance and ensured timely submissions to regulatory bodies.
2. Enhanced Document Consistency: By automating document conversion and standardization processes, Adlib eliminated the inconsistencies that plagued the company's previous system. This led to more accurate and reliable clinical documentation.
3. Improved Operational Efficiency: The seamless integration of Adlib with M-Files streamlined document workflows, reducing manual intervention and speeding up document retrieval, review, and approval processes. This enabled the company to reduce their clinical document processing time to 15 seconds per document, saving over 8,500 knowledge worker hours in a year.
4. Superior Quality Control: Automated quality checks and consistent document formatting enhanced the overall quality of their clinical documentation. This improved sponsor relations by delivering high-quality, compliant documents that met the highest standards in the industry, and securing a market leading position for the organization.
5. Scalability and Growth: With a unified and automated document management system in place, the company was better positioned to scale its operations. The company could now handle a higher volume of clinical trials without the need to expand its clinical operations team, thereby optimizing resource utilization and supporting business growth.

Conclusion

The integration of M-Files for global document management and Adlib for critical workflow automation allowed the company to design a purpose-built publishing system for solving their unique challenges. By addressing the challenges of system fragmentation and document inconsistencies, the company was able to enhance compliance, improve operational efficiency, and maintain the highest quality standards in its deliverables. This strategic initiative not only positioned the company as a market leader with increased share but also enhanced its capacity to support more trials and has played a pivotal role in the development of 85% of FDA-approved drugs in recent years. This remarkable track record demonstrates the company's commitment to advancing scientific research and enhancing patient care through innovative solutions.