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Graham Bunn is the vice president, eClinical Business for Quintiles Limited, Station House, Market Street Bracknell Berkshire, RG12 1HX, UK, +44 1344 708000, fax +44 1344 708300, email: graham.bunn@ quintiles.com.
Partnership agreements for CROs and eClinical technology providers can be as beneficial as sponsor/CRO partnerships.
In the perfect world (a flat floor), a three-legged stool is always more stable than one with two or even four legs. In the world of outsourcing however, having more than one outsourcing provider involved in a clinical trial can soon become complicated. There are more contracts to deal with, more inter-relationships between companies and more cracks for responsibilities to fall between, and it becomes more difficult to determine who needs to fix what if things go wrong. This has resulted in a growing trend towards full-service strategic outsourcing with large global CROs who can provide all of the services required for a clinical trial. The outcome is one contract and one outsourcer responsible for delivery. These outsourcing models make sense, except in today's market there is the growing number of technology providers to consider who supply the large range of eClinical solutions required to efficiently run a modern clinical trial. Clinical trials management systems (CTMS), randomization and drug trial supply management, electronic data capture (EDC), medical imaging, electronic patient reported outcomes, and even electronic regulatory information management are but a few of the technology systems frequently used. This often results in a three, four, or more legged stool for the biopharmaceutical company to manage through the outsourcing process with the resultant complexity of contracts, work processes, team management, and technology overload for the users. There are two changes required in the industry to simplify clinical trials outsourcing for the sponsor who is looking to gain all the efficiencies possible through outsourcing while at the same time continuing to gain the benefits possible through the use of eClinical solutions.
Just as CROs grew by acquisition and organically to ensure they could provide the wide range of services and geographic presence that sponsors were looking for from their strategic outsourcing partnerships, technology companies now need to grow through the acquisition and internal development of end-to-end eClinical solutions. This evolution has been evident by some of the big players in the industry for some time. The growth in solutions offerings, combined with the industry's move towards cloud based software-as-a-service solutions, has allowed eClinical technology companies to develop more holistic clinical trials technology. The industry has moved away from the need for multiple applications requiring study specific point-to-point custom integrations and towards the convergence of applications and data that simplify the experience for the end users—think of the mobile phone, camera, music player and PC coming together as the smartphone (Figure 1).
Convergence of technology brings the optimal product suites the industry is looking for to deliver clinical trials from a one-stop-shop, avoiding the technology chaos of multiple applications and study specific custom integrations by simplifying the workflow and allowing consolidated views of information for effective decision making throughout the lifecycle of clinical trials or programs. Outsourcing technology convergence allows CROs to achieve significant efficiencies to their processes based on these advantages and hence offer these to their sponsors to gain competitive advantage.
CROs have long argued that if they are not allowed to select the best technologies to run a clinical trial, then it is difficult, if not impossible for them to offer significant process and technology advantages. Traditionally the industry (especially large pharma) has specified the individual applications that a CRO will use for a study. The CRO then has to work with one CTMS system, a different EDC provider, and yet another laboratory service; this piecemeal process is repeated from study to study resulting in many study specific custom integrations, disjointed processes, and painful technology experiences for all of the end users due to the resulting technology chaos. The industry needs to realize that only by devolving technology selection responsibility to the CROs, can significant gains in usability, process (time/cost), and outsourcing management be obtained with significant reductions in wasted non re-usable application integrations. Once CROs are left to choose the technologies, they also become fully responsible for the delivery from their selected vendor or vendors. The sponsor signs just one contract with the CRO, and there is no need to control multiple technology vendors and end up with situations of avoidance of responsibility.
This change in approach by sponsors has changed the way technology vendors work with their CRO customers. Some large technology vendors have developed a CRO partner program to better serve this segment of the industry, and in the process provided benefits to both the CRO as well as the sponsor. Vendors have implemented strictly controlled, high quality training and testing programs along with user testing (certification), company accreditation and associated branding to recognize high quality CRO partners who are familiar with their technology. This not only enables the CRO to differentiate themselves in the marketplace, but also allows sponsors to feel confident that their strategic CRO partner is correctly qualified and supported throughout the contract duration. The relationship accurately mirrors the strategic partnerships that sponsors and CROs are now establishing. The vendor knows that this partnership is important, for the long term, and that the CRO is relying on their delivery to ensure on-time, on-budget delivery to the sponsor. The CRO knows they can rely on the vendors attention at all times, have simplified contracting via an overarching master services agreement, and can focus on one technology provider to optimize service delivery. Clearly some things work better as partnerships and the industry is learning that this is just as true for CROs and eClinical technology providers as it is for sponsors and CROs, and the sponsors benefit from both types of these strategic partnerships.
Graham Bunn, PhD, is Vice President, Partnerships at Perceptive Informatics, Lady Bay House, Meadow Grove, Nottingham, NG2 3HF, UK, e-mail: [email protected].