\nAs clinical outsourcing continues to grow and competition
\nintensifies, improving clinical trial quality, speed, and agility are
\noften prerequisites for any contract research organization (CRO)
\nthat aspires to grow its business. Modernizing the way that GxP
\nquality content and data are stored and used is critical to
\nimproving efficiency and compliance while ensuring risk-based
\nquality management.\n<\/p>\n
\nAdvanced Clinical, a full-service global CRO, turned to ³Ô¹Ï±¬ÁÏ Quality Cloud to streamline quality
\ncontent, processes, and training. Named one of Inc.\u2019s fastest growing privately owned businesses in
\nthe US in 2019, Advanced Clinical has expanded rapidly over the past few years, opening new offices in
\nAsia Pacific and Eastern Europe to complement the company\u2019s North American and Western European
\nlocations. The investment in modern quality solutions was part of an overarching effort to scale while
\nimproving the speed and efficiency of its quality and overall clinical operations.\n<\/p>\n
\nPreviously, the CRO handled most quality processes manually. Updating and maintaining training content, standard
\noperating procedures (SOPs), audit reports, deviations, and corrective and preventive actions (CAPAs) involved tedious
\nand error-prone steps. The company relied mainly on email for exchanging controlled documents and Microsoft Excel for
\ntracking workflows. \u201cAt the time we were still using SharePoint for document storage and tracking,\u201d recalled James Kalemis,
\nsenior director of information technology, governance, risk, and compliance at Advanced Clinical. These tools and manual
\nprocesses increased compliance risk and diverted staff from value-added work.\n<\/p>\n
\nAnother challenge was the company\u2019s existing learning management system (LMS), which did not support online training or
\naddress variability in training documentation, requiring manual efforts. When the company\u2019s contract with the vendor ended
\nin 2019, Kalemis and his team had to find an advanced LMS solution\u2014and install and implement the solution in nine weeks.
\n\u201cSome people doubted this could even be done in such a short time,\u201d he recalled.\n<\/p>\n
\nKalemis had led the company\u2019s validation effort for ³Ô¹Ï±¬ÁÏ eTMF seven years earlier and was already familiar with
\nthe Vault platform. After evaluating several solutions, he and his team selected ³Ô¹Ï±¬ÁÏ QualityDocs and ³Ô¹Ï±¬ÁÏ
\nTraining to streamline document and training management in a single system. Part of the ³Ô¹Ï±¬ÁÏ Quality Cloud, the
\ncombined solution automated the content management and the design and delivery of training assignments for improved
\nefficiency and effectiveness.\n<\/p>\n
\nThe SCORM (Sharable Content Object Reference Model) capability within Vault Training facilitated the sharing of online
\ntraining programs with Advanced Clinical\u2019s customers.\n<\/p>\n
\nThe single environment for both content and training management streamlined quality workflows, simplified administrative
\ntasks, and improved productivity. \u201cThe connectivity, useability, and efficiencies gained from having ³Ô¹Ï±¬ÁÏ Training and
\nQualityDocs running on a single platform have been great. Now we can create, review, and approve quality documentation
\nin QualityDocs and deliver training assignments in the same system, which has resulted in huge compliance and productivity
\nincreases,\u201d said Kalemis.\n<\/p>\n
\nEventually, convinced by the savings and efficiency achieved by the initial rollout, Kalemis and his team decided to implement
\n³Ô¹Ï±¬ÁÏ QMS to achieve better control and visibility into quality processes. \u201cThe addition of ³Ô¹Ï±¬ÁÏ QMS complemented the full
\n³Ô¹Ï±¬ÁÏ Quality Cloud, increasing transparency and streamlining quality processes across the company,\u201d said Kalemis.\n<\/p>\n
\nThe benefits of a unified system for quality management system content, training, and processes have continued to accrue.
\n³Ô¹Ï±¬ÁÏ Quality Cloud has eliminated the need to integrate multiple systems from different vendors. It has also dramatically
\nsimplified tracking and pulling historical quality data for reports, meetings, recurring qualification audits, and CAPAs. \u201cIn the
\npast, it could take two weeks just to locate the data required for quarterly management review meetings. Even preparing for
\nbiweekly status meetings with customers could take 60 to 90 minutes per auditor. Now, this time can be spent on value-added
\nactivities that improve quality and compliance,\u201d said Kalemis.\n<\/p>\n
\nAdvanced Clinical wanted more than an effective solution; rather a strategic vendor partner that would collaborate on
\nways to improve entrenched work processes. ³Ô¹Ï±¬ÁÏ\u2019s implementation team invested the time to learn Advanced Clinical\u2019s
\nday-to-day quality operations to identify areas for improvement. \u201cWe wanted best practices, and to see what we needed to
\nchange in order to gain the greatest efficiencies,\u201d Kalemis stated. \u201cWe\u2019ve since updated some SOPs to leverage more of the benefits that ³Ô¹Ï±¬ÁÏ\u2019s systems brought us and have eliminated 95% of manual processes so far.\u201d\n<\/p>\n