By Graham Bunn
Traditionally, the biopharmaceutical industry has relied heavily on outsourcing R&D trial tasks to CROs that help manage clinical trials. Large pharmaceutical companies tend to use CROs for overflow study volume or large, global trials. Small and medium pharmaceutical/biotechnology organizations typically outsource complete R&D functions they cannot or wish not to develop in-house.
Current data shows this outsourcing trend is only set to continue, and a steady rise in future outsourcing is predicted. It is vital that pharmaceutical companies of all sizes get this process right to remain competitive and drive toward more efficient yet higher quality operations.
To date, a large volume of studies outsourced by the industry have been tactical engagements in which a sponsor outsources either individual tasks or perhaps the entire management of a single clinical trial. A biopharmaceutical study team, assisted by their outsourcing group, will issue a study-specific RFP, receive responses from a variety of (or list of preferred) CROs, and assess each response based on the CRO’s ability to deliver on their requirements. The emphasis is for the sponsor to hold each service provider to metrics around individual study delivery — typically timeliness, cost, and quality. It is not that different from a teacher giving a child a homework assignment and then grading it (paying, in the CRO’s case) according to the results. For their part, service providers measure their own success by their ability to profitably meet the sponsors’ delivery criteria. In tactical engagements, the CRO is generally allowed to choose how they work to ensure they do not have a process or technology excuse for failing to deliver. In working with a variety of CROs in this model, sponsors must continually adapt to the CROs’ different work processes, SOPs, and technologies. This results in an inefficient way for the sponsor and associated site staff to work, and change is clearly needed.
Sponsors Go Strategic
Sponsors have moved more toward strategic outsourcing to solve the inefficiencies in tactical CRO outsourcing that are particularly obvious in selection, contracting, process and technology change, reporting, and data delivery. Recent examples of strategic outsourcing relationships include GSK with PAREXEL and PPD, BMS with PAREXEL and Icon, and Sanofi with Covance. Typically, CROs selected as strategic partners are awarded a two-to-five-year contract. This eliminates the need for multiple rounds of RFPs, vendor selection, and contract negotiation. Moreover, the outsourcing organizations work according to the sponsors’ SOPs, rather than dictating their own, following agreed-upon standards and formats for reporting and data delivery. The sponsor benefits from a reduction in the overhead associated with contracting with multiple outsourcers as well as a more efficient approach to reporting and data management. Moreover, the CROs are usually able to offer lower rates given the longer-term guarantee of a volume of business.
Another benefit of this model to sponsors is that they can take typical tactical outsourcing performance metrics — timeliness, quality, and cost — and add metrics associated with multiple studies. For example, the service partner is expected to drive long-term increases in efficiency, time, and/or quality over the duration of the contract — such as a 10% reduction in study costs along with a 15% improvement in quality and 5% reduction in study timelines over the duration of a three-year contract. From this perspective, strategic outsourcing is a win-win for both pharmaceutical company and CRO. In the classroom analogy, the sponsor is now giving the outsourcer more autonomy, akin to a high school teacher assigning their pupil many pieces of homework with the confidence that the work will be completed to a high quality and standard. The teacher also has the expectation that the ambitious pupil’s work over time will get even better as the pupil prepares to depart for a university or the outside world and needs to learn to work more independently.
Despite all of the benefits, the current trend towards more strategic outsourcing represents a huge missed opportunity to change the way the industry works with CROs. Moving to two to three preferred partners is a tiny first step in outsourcing maturity that only simplifies the process and gains some efficiency over time through increased elements of trust. To achieve much greater efficiencies, there is a need to adopt a more university research-centric approach. In that environment, it is common for professors and research students to openly collaborate on the same topic. While the professor’s name may well be the one that ends up on the published scientific paper, there is knowledge that the research students often contribute as much, if not more, to the original work through a cooperative, creative environment.
For this approach to work in an outsourced clinical trial environment, it is necessary to standardize both the outsourcing and clinical trial process. That requires a framework of shared technology and a process of technology and outsourcing governance. In the past, clinical trials technology was largely client/server-based, and both sponsors and CROs preferred to keep the infrastructure (and access to it) behind firewalls. The beginning of the century brought change when Web-based Software-as-a-Service (SaaS) solutions for electronic data capture (EDC) started becoming popular. Suddenly, sponsor, CRO, and site could easily share access to the same application, see the same data, run the same reports, and work as a team to ensure optimal trial conduct. If problems were identified, such as slow recruitment or monitoring bottlenecks, the sponsor, outsourcer, and if necessary, the site could meet and discuss the issues and agree to the best solution to the problem, all armed with the same information.
The industry has rapidly caught on to the benefits of SaaS technology, and many SaaS-based solutions are now available. They exist not only to support data gathering through EDC but for a range of clinical activities including protocol design, document management, clinical trial management, trial master file, site budgeting and contracting, randomization and trial supply management, and patient reported outcome (ePRO). Each individual SaaS solution brings advantages to site, CRO, and sponsor, but through the rapidly maturing portfolio, it is now possible to conduct an entire clinical trial using only SaaS technologies — from protocol design and creation, study budgeting, and contract negotiation to study conduct, document management, and finally, data analysis and submission.
While the focus to date has been on the advantages of individual applications — typically faster deployment and productivity, streamlined use and management, increased flexibility and scalability, and better reliability and performance — little has been made of the fact that SaaS applications provide a secure mechanism for multiple organizations around the world to share access to common data and information. This offers tremendous potential within the strategic global outsourcing business if a few guidelines are followed:
Do care about technology choice. Traditionally, the pharmaceutical industry has left technology choice to its outsourcing organizations. Whether tactical or strategic, if each of the outsourcing organizations is using different technologies, opportunities for efficiency gains will be missed. For best results, the pharmaceutical organization should standardize on SaaS applications that best support their outsourced activities.
Do not think it is just about technology. Technology choice needs to be supported by a SaaS outsourcing deployment framework (governance) before deploying to multiple CROs. Using a common technology is no guarantee of common processes, standards, or workflow. Thinking about global library standards, common elements of look and feel, workflow processes, and data standards can impact the efficiencies of those using the application — sites, clinical monitors, data managers, and statisticians, as well as managers reporting on progress.
Do think about an integrated approach to clinical trials. Do not look at the individual SaaS technologies as point solutions. Significant efficiency and quality gains are available by taking a holistic approach to integrating solutions and processes across different technology suppliers or by integrating SaaS technologies with key in-house solutions. Standard integrations using open Clinical Data Interchange Standards Consortium (CDISC) and Web services standards are essential. Once data is entered in SaaS technology, it should not need to be reentered in another system.
Do not use the SaaS tools to micromanage. Use the tools to work together and create increased bandwidth to deliver high-quality, faster, and safer clinical trials. All organizations need to fail if any one organization fails to encourage this process, so joint risk-sharing is an important element in outsourcing strategy.
Do think outside of the box when deploying SaaS solutions rather than following the pack. In tactical outsourcing, the sponsor will design the protocol, the CRO will negotiate the site budgets, control the site contracts, build the electronic client report form (eCRF), etc. SaaS solutions enable workflow within a task across different and remote people and organizations. This mix of workflow and expertise across organizations can dramatically help to reduce study costs, avoid high dropout rates/nonevaluable patients, increase patient safety, and hence improve the opportunities for a rapid and successful final study submission.
About The Author
Graham Bunn, Ph.D., is the VP of partnerships & alliances at Medidata. He has more than 20 years of experience in the pharmaceutical industry, coordinating and managing relationships with various CRO and systems integrator partners in the sales and delivery of Medidata products and services.