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The Importance of Standardization in Clinical Outsourcing



At the recent PCMG conference in Malta, Adrian Otte ( Independent Consultant, formerly VP Global Development Operations at Amgen) presented to delegates the strategic choices open to sponsors when  choosing an outsourcing model and the three fundamental issues in play: standardization, flexibility and cost. In Dr. Otte's view, standardization of systems and processes is key, but is often overlooked as a factor by companies of all sizes when deciding how to outsource clinical trial activities. In this blog, Dr Otte joins us to share his insights on this topic, as well as this views on how outsourcing has evolved in recent years, and the future trends that will have most impact. 


The importance of standardization in clinical outsourcing
When outsourcing clinical research services, one of the key issues a biopharma company needs to resolve is standardization. In order for the sponsor to properly oversee CROs and their activities, unified processes, job descriptions, and resource algorithms are critical. Without this consistency, it is extremely difficult for the sponsor to properly account for the CRO’s work, integrate clinical data, and evaluate safety data signals. There are two commonly used outsourcing models that, in my opinion, most effectively address the standardization issue. In the first approach, the sponsor selects a single CRO for all their trials and uses their systems and processes. This approach does allow the sponsor to effectively oversee work across multiple studies and has the obvious advantage of simplicity. However, its inherent risk is dependency on a single supplier. For a smaller organization, this may not be an insurmountable issue, but is more problematic for larger organizations with more clinical trial programs in play. Another popular framework is to use a single set of systems and processes that are either proprietary to the sponsor company or are acquired from another service organization. This model is often structured around functional outsourcing, whereby the sponsor acquires services for clinical monitoring, data management, and statistics, for instance. These services could be outsourced either to the same vendor or different vendors, but are overseen using this consistent suite of systems. Clearly, this option entails more management complexity than option one, due to the involvement of multiple suppliers. However, thanks to the integrated platform of processes, it allows for robust oversight while mitigating the risks inherent with the full service, single vendor approach. Outsourcing that uses multiple CROs and disparate systems may become easier to manage in the future with the advent of more effective data aggregation tools that allow a single way to oversee the data. Until this becomes a reality, the first two options tend, in my view, to be more effective at addressing the standardization issue.

Evaluating the outsourcing approach that is right for you
If you're a top ten pharma, then using a single supplier can be a significant risk, whereas for a smaller, virtual company this may represent a reasonable choice. For a medium or large size pharma with its own set of systems and processes, then an FSP ( Functional Service Provider) approach can be an excellent option. It simplifies the oversight while providing a lower cost, flexible, and easy to implement model. One disadvantage is the need to maintain your own systems and processes. If this proves impractical, then using external systems and processes maintained by an external provider can be a viable option.

Commitment is key to success
Commitment on both sides is key to making a Functional Service model work. It is not unusual for it to take two years for the partnership between the sponsor and CRO to fully gel. During that period, it requires commitment from operational staff and leadership to say, "Despite the challenges, we're going to make this work. We're going to learn from the mistakes. We're not going to walk away as soon as we have the first challenge." Clinical research is hard and not a simple, repetitive process. Every study is different, with different teams and personalities, so there will naturally always be challenges to overcome in any outsourcing relationship.

Quality and cost outcomes from an FSP partnership
By using a consistent set of systems over a sustained period of time, it's possible to realize incremental, but impactful improvements through identifying and addressing quality issues, amending processes and enhancing training and development. This, in turn, can result in improved quality outcomes.
Over the last 15 to 20 years, I've observed that functional outsourcing often delivers cost savings of 20-25% when compared with full-service models. This is often due to the flexibility you have to outsource your clinical services within the relevant geographic region, and so benefit from local costs. There can also be less duplication of efforts in terms of project management activity, as well as simpler administration and fewer change orders.

Evolution of outsourcing practices
Over the last five years, the volume of work that is outsourced to CROs has continued to increase. There has also been a shift in expertise from sponsors to CROs and an accompanying improvement in performance over that period. Sponsors now recognize that outsourcing is a key way that clinical trials are delivered, and rather than resisting that basic premise, are focusing on collaborating more effectively with outsourcing partners.

The future of outsourcing
In the future, technology to integrate clinical data and oversee suppliers will improve, and this will, in turn, allow sponsors greater flexibility in their outsourcing practices. Taking a broader perspective, we can also expect that artificial intelligence and machine learning tools will transform how clinical monitoring and data review activities are conducted. As this evolution occurs, we can expect to see CROs shift towards the provision of technology solutions, as these routine activities benefit from automation.
The emergence of virtual trials through organizations like Science 37 is a compelling trend that could deliver some key productivity advantages. A virtual site allows a sponsor to recruit patients throughout the country without the geographic barriers that hamper patient enrollment. The current patient recruitment model is, as we all know highly inefficient. Between 10 and 25% of sites never recruit a patient and another 25% recruit only a very small number of patients. In some ways, the latter scenario is more problematic, as you still need to allocate resources to monitor these sites, and clean the data. Tackling the problem of patient recruitment would not only address a huge financial burden but even more importantly, will help accelerate timelines. The majority of time spent for most clinical programs is on patient recruitment. The design and planning of a trial also take a long duration, but by no means compares to the time spent recruiting patients. As technology and risk-based monitoring have improved, we have seen close-out and reporting timelines decrease. However, patient recruitment remains a key challenge.
Clearly, 90% clinical research won't be done through Science 37 or this type of organization, but even if that percentage could be 20 or 30% the impact would be very significant. Clinical research is a tough enterprise, and currently, there are only a few sites that are entirely focused on it. It can be difficult for a normal clinic to accommodate the expertise and commitment to regulation and documentation that is needed. Using telemedicine and professionals who are dedicated to gathering clinical data in the appropriate way, would improve quality and enhance recruitment efforts.

Otte_Adrian_2011About Adrian Otte MB, BCh, FFPM 

Dr Adrian Otte is an Independent Consultant within the pharmaceutical industry with more than 35 years of industry experience. He retired from Amgen in 2018, where he was most recently vice president, Global Development Operations.  Prior to Amgen, he served as senior vice president, Worldwide Development Operations  at Pfizer for six years and was responsible for phase 1-4 clinical trial operations worldwide. Earlier in his career, Dr. Otte was chief operating officer, Clinical Studies and Healthcare Research, at Innovative Clinical Solutions, Ltd., one of the largest clinical site management organizations in the U.S;  vice president, Medical Research for Zeneca Pharmaceuticals; and  held several positions of increasing responsibility at PAREXEL International Corporation. Dr. Otte began his career as Medical Advisor for Solvay Duphar in the United Kingdom, where he spent 10 years, eventually overseeing the company’s European Clinical Research organization.  He received his medical degree from the Welsh National School of Medicine in Cardiff, United Kingdom.


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