The Agile CRO: How to Gain a Competitive Advantage with OpenClinica Enterprise

The clinical trials software realm is replete with solutions promising to ease the pain of data collection and accelerate clinical trial productivity. However, many of these systems carry high overhead, rely on aging technology, and have pricing models that make it difficult to budget with accuracy. While this paradigm may be grudgingly accepted among trial sponsors, it falls short of providing CROs with what they need to ensure their success. CROs today are successful when they are agile. The ability to quickly deploy studies, manage complexity, and enhance quality--and to do this within a strict regulatory environment--are essential ingredients to success. OpenClinicas unique model which leverages modern, non-proprietary technologies and standards allows a CRO to run its business more effectively while maintaining strict regulatory compliance. This article explores ways in which OpenClinica Enterprise can help a CRO meet these strategic objectives. Achieving Regulatory Compliance While it is imperative that clinical trials are operated in a regulatory compliant manner, it can be a challenge for some CROs to implement and maintain the infrastructure and documentation necessary to ensure software is validated for regulatory compliance under the guidelines of the FDA and other regulatory bodies. The investment required to validate (and re-validate) software can be significant. (The cottage industry of systems validation practitioners that has arisen is one indication of this.) OpenClinica Enterprise greatly reduces this regulatory compliance burden, making it feasible for even very small CROs to achieve and maintain regulatory compliance. In addition to having critical software features for regulatory compliance (such as electronic signatures, audit trails, etc.) the OpenClinica Enterprise edition is produced and tested according to strict, auditable quality system and software development lifecycle (SDLC) methodology. It is provided as fully validated software, complete with resources to ensure ongoing validation and compliance. Flexibility and Control With a sufficient level of control over its technology, a CRO can make intelligent decisions that align with its business strategy. Being able to decide at a granular level, which skills and services it makes sense to provide in-house vs. from outside resources can positively affect both the quality and profitability of the CROs services. Depending on the circumstances, some of these decisions may also need to change on a project by project basis.

OpenClinica, 460 Totten Pond Road, Suite 200, Waltham, MA 02451 p 617.621.8585 f 617.621.0065 www.openclinica.com

OpenClinica Enterprise gives a CRO a high level of choice and control. For instance, the study set-up process is often most productive when it is a direct collaboration between the sponsor and the CRO. The OpenClinica Enterprise edition provides easy-to-use visual study build tools that allow more time to be spent perfecting the protocol as opposed to haggling with vendors or diagnosing technical issues. Sponsors can be granted system access to see the design as it undergoes milestones in the build process. Not only does this reduce barriers to study startup, it can greatly facilitate mid-study changes. The process of transferring the skills and knowledge for building studies in OpenClinica--commonly called tech transfer--is extremely rapid. If the CRO does not wish to have OpenClinica study builds as a core competency in-house, they always have the option of outsourcing this function to their client services team at OpenClinica. Similarly, CROs are able to make flexible choices with other aspects of the technology. For instance, some CROs choose to host OpenClinica Enterprise internally, while many opt for OpenClinicas secure, high performance, zero data loss Optimized hosting. Some integrate it with other modules and systems to create a unique offering to differentiate itself in the marketplace. If a validated platform is not needed for a project, the freely available OpenClinica Community edition (download here) can enable CROs to obtain a robust system that eliminates third-party EDC vendor costs. Such broad choice allows the CRO to optimize its use of technology, both by project and across the company, in order to deliver higher quality services. Interoperability The ability to readily extend and integrate the OpenClinica software with other systems for the real-time, 21 CFR Part 11-compliant exchange of clinical data and metadata can help drive productivity. The open web protocols supported by OpenClinica (such as HTTP, REST, SOAP, and XML) enable robust interoperability at a cost that makes business sense. OpenClinicas transparent, publically documented use of these web protocols along with CDISC standards such as ODM and CDASH make it possible for CROs to easily move data in and out of OpenClinica, integrate with other applications, and maintain re-usable libraries of standardized CRFs and other study components. Such standardization can lead to more efficient operations within the CRO and make the CRO a more attractive partner for sponsors who have multi-study clinical programs. Many CROs gain a competitive advantage with OpenClinica by tightly integrating it with other system to create a unique, eClinical infrastructure, that is tailored to their business and adds value and differentiation to the CROs offering. For example, it is common for CROs to integrate OpenClinica with both internal systems as well as third-party systems and data sources such as laboratories, devices, registries, analytic applications, libraries, and CTMS software. Favorable licensing terms help justify the investment in such integrations and make

OpenClinica, 460 Totten Pond Road, Suite 200, Waltham, MA 02451 p 617.621.8585 f 617.621.0065 www.openclinica.com

it possible to keep a fully integrated eClinical system on-the-shelf ready to go as new projects come online. Cost Effectiveness At the end of the day, a CRO must deliver quality services in a profitable fashion. Oftentimes CROs find themselves in highly competitive situations, and must look towards managing their costs in order to achieve profitable revenue for a given price point. While EDC software has a reputation for being prohibitively expensive for all but the largest trials, OpenClinica is proof positive that it doesnt have to be that way. OpenClinica Enterprise is provided under a straightforward, low cost pricing structure. While many EDC vendors charge based on the number of studies, users, sites, the amount of data collected, and other inherently unpredictable factors, OpenClinica takes the guesswork out of the cost of EDC by offering a simple flat fee per instance of the software for the OpenClinica Enterprise edition (compare product editions). Whether a CRO is new to EDC, wishing to replace a system, or simply looking to add a system to better serve lower budget studies, OpenClinica Enterprise can help a CRO be more effective. Productivity tools that offer increased choice, interoperability, and predictable, cost effective pricing can help a CRO deliver higher quality products and services, and to do so in a more profitable way. These are some of the characteristics that have helped make OpenClinica the fastest growing software for clinical trials. Please contact us for more information about how OpenClinica can help make your CRO more agile. Ben Baumann Director of Business Development bbaumann@openclinica.com
OpenClinica is currently seeking partnerships with CROs who wish to: Augment their core capabilities Obtain additional revenue sources Enhance their brand and reach Obtain tailored support from the worlds foremost OpenClinica experts Leverage existing, proven assets and knowledge critical for delivering successful, profitable OpenClinica-powered studies

Working with an OpenClinica partner gives customers a higher level of assurance they are working with a cohesive, coordinated team that is focused on the customers success. For more information about the OpenClinica partner program for CROs, please reach out to us online at www.openclinica.com/partner-inquiry.

OpenClinica, 460 Totten Pond Road, Suite 200, Waltham, MA 02451 p 617.621.8585 f 617.621.0065 www.openclinica.com