Box GxP: From Clinical Site Feasibility to Final Protocol

By Manu Vohra, Vp of Content management, USDF Life Sciences

The phenomenon of digital transformation is emerging in every industry and IT organizations are developing solutions to transition their legacy systems to newer cloud technologies. Being in a highly-regulated industry, Life Sciences organizations have the challenge of developing such strategies to transform their businesses, increase productivity and enable agile business models without compromising security and compliance requirements enforced by regulatory industries. Clinical operations and developmentis one of the areas where significant thought must be put in to deploy a cloud strategy.

Current Clinical Operations Environment

Conducting clinical trials in the past involved generating truck-loads of paperwork and countless hours of overhead in communications between clinical operations personnel and the various internal and external partners. With the increase in number of biotechnology companies and small emerging institutions conducting clinical trials, the market has responded with a rise of Clinical Research Organizations (CRO’s) and various other external partners in the clinical value chain. These trends have been met with an increased need in regulations, recommendations and compliance (GxP) standards to be applied to any sized organizations conducting clinical trials.

Challenges in Conducting Modern Clinical Trials

Clinical operations groups today, understand that they need to communicate and collaborate with partners internally, externally and globally in order achieve their goals. From the early stages of trial planning, through various protocol development stages to confirmation of a final study protocol, there are thousands of hours of work put into development of clinical materials such as:

• Study Risk Assessment Documents
• Sponsorship Documents
• Site Feasibility Surveys and Study Visits
• Site Procedures and Training Records
• Trial Master File (eTMF)
• Contracts and Agreements
• Final Study Protocol

And these documents are generated even before a clinical trial can commence and require various stages of reviews and approvals with stakeholders that can be scattered across time-zones. GxP controls need to be in place for all electronic content with proper audit trails, Part 11 compliance and validated retention policies.

A study by ClinicalTrials.gov shows that 70% of trials are over budget and exceed original timelines. In addition, study protocol complexity is on the rise resulting in more indirect costs to organizations and affecting the time to market for the drug maker.

Going Digital

When ECM systems were first introduced to support clinical operations, with custom electronic workflows for reviews and electronic signatures, it took about a decade for the stragglers in the industry to adopt a path that had already been paved by early adopters. These organizations had showed gains in efficiencies and reduced time to market that was clear and apparent. Now with advent Digital Transformation in various industries, the Life Sciences industry is at a similar inflection point today.

Digital Transformation (Dx) providers have launched several solutions to support the Life Sciences. For example, according to a study by Forrester Research, the use of e-signatures alone, has grown at an average annual rate of 53% since 2012. Digital Transformation (Dx) is not a privilege of the digital industry revolutionists but readily available to all who care to ask and challenge industry norms by adopting the power of cloud computing, cloud content management, “flip-on” integrations, and world class security with a platform like Box.com

Box GxP for Clinical

The ‘Always-updated’ cloud design and secure external collaboration power of Box makes it a prime cloud platform for launching clinical trials. With the recently available method of “Always-On” automated testing for compliance, Box can now be qualified under GxP guidelines (GAMP-5 level) enabling customers to store, manage and distribute regulated content. This allows operations to scale with the speed of the business and enables enterprise owners to consolidate the ever-expanding portfolio of GxP vs Non-GxP systems.

The communications overhead in exchanging clinical study start-up documentation such as site documentation and contracts can be securely sorted into team folders in Box consisting of varying security permissions based on the study. Every time a new site is confirmed for the study, the site activation process will be as fast as their internal processes allow because the onboarding of new external resources in a Box based GxP compliant solution takes minutes, not days.

Post collaboration, GxP Clinical documents, have several downstream uses such as development of the electronic Trial Master File (eTMF). Another advantage of consolidating documents that are used across multiple application value chains is that they can be easily integrated with other applications via open Box APIs, while still maintaining a Single-Source-Of-Truth and the original retention policies that were initially applied at approval.

Final thoughts

Content Management is certainly not a new concept, and neither is cloud storage; but the Life Sciences industry will need champions to embrace this new solution and re-imagine processes to join the Digital Transformation Wave. Transformative technology solutions demand transformative GxP processes and controls. With Box GxP Validation available to all Life Sciences customers, the utility and efficiencies of launching and expanding Clinical Trials on a Box Based Platform will only grow from here.

To learn more about how you can take advantage of Box GxP Validation, register now for our upcoming webinar on February 14.

About the author

Manu Vohra is the VP of Content Management at USDM Life Sciences. He is a seasoned professional with two decades under his belt deploying content management solutions for Life Sciences while running operations within several IT functions supporting Drug Discovery to Commercialization. He specializes in guiding Biopharmaceuticals in developing long term content management strategies by applying Digital Transformation principles and technologies.

USDM Life Sciences is the leading global professional services firm focused on increasing the capacity of Life Sciences and Healthcare organizations to accelerate innovation and maximize productivity. They have been helping organizations digitally transform their businesses since 2000, whether it’s movingto the cloud, going mobile, or easing the burden of compliance. For more information on USDM Life Sciences, visit their website.

BY MANU VOHRA, VP OF CONTENT MANAGMENT, USDM LIFE SCIENCES