2014 Trends: The Changing Landscape of Outsourcing (3/3)

19 February, 2014, by ClinCaptureTeam

Outsourcing Pharma, the online news platform on pharmaceutical manufacturing, supply, and contract research, have estimated that pharmaceutical companies use Contract Research Organizations (CROs) and other commercial resources for just 40% of the work that could be outsourced. However leading research indicates that this ratio is bound to increase. According to a report from market research firm Transparency Market Research, in 2013 the total amount of work outsourced to CROs globally reached $31.1B, almost $10B more than in 2009. The report also indicates that the outsourced research market is expected to reach $65.03 billion by 2018.

In the context of a progressive and steady economic recovery, sponsors and CROs are looking for the right outsourcing models to sustain their mutual growth and share complementary expertise for the long-term, while ensuring flexibility in the short-term. Of course, sponsor companies are still facing a number of challenges, including growing R&D costs, pricing pressures, regulatory evolutions, slower growth rates, and patent expiration. These trends are enticing pharmaceutical, medical device, and biotechnology sponsors from Big to Small Pharma and to find the right model to balance and manage resources between in-house and outsourced projects.

Intimate long-term partnerships

According to Parexel’s President Mark Goldberg, there is a trend toward relationships between CROs and sponsors becoming more intimate and strategic. More and more, CROs are engaged to deliver technology and expertise, not just short-term resources. I think this is particularly true for big CROs and large sponsors, such as the known partnership between Parexel and Pfizer. Bayer reported in Clinical Leader that one of its success stories is their partnering agreement with Covance, which Bayer now use as a key example of how to successfully execute partnerships. Large players now have more visibility in their pipelines and are constantly looking to form long-term partnerships as they plan their drug development efforts for years to come. It makes sense for big companies to rely on experienced CROs to help them streamline their processes.

Flexible short-term models

How about the small- to mid-sized sponsors companies? The Functional Service Provider (FSP) model has proven to be an effective tool in reducing costs for small to mid-sized players. From our experience at Clinovo, we can estimate this model can save 30-40% on direct cost savings on top of larger indirect cost savings. The flexibility, speed of implementation, and ability to scale up or down projects rapidly has been attracting small to mid-size pharmaceutical, medical device and diagnostic companies to the FSP model.

Innovation-driven outsourcing

With study designs becoming increasingly complex, sponsors are becoming more reliant on eClinical systems to handle complex protocols as well as handle ever-evolving regulatory requirements. Innovation amongst CROs and software vendors will continue to scale up in 2014, with a focus  on broadening and streamlining access to relevant data, tempering the risks associated with clinical trials, and increasing the predictability of success or failures.

Risk-based monitoring methods and processes are likely to command more and more importance. For example, Clinovo unveiled a risk-based monitoring module at the latest Outsourcing in Clinical Trials West Coast Conference, which further extends the capability of our open source EDC system ClinCapture . ClinCapture was integrated with Patient Profiles to create individual reports for each subject. It allows anyone (with or without a clinical, statistical, or programming background) to easily review each patient’s time on study, identify errors in data, and observe efficacy. Patient Profiles automatically runs algorithms to mine your clinical data and identify data that is unusual. The rules are inferred from the data without needing to hard code the error checks.

More game-changing start-ups are changing the way CROs and sponsors collaborate through technology. GoBalto and Comprehend Clinical can be clearly identified as two examples of disruptive innovation in the industry, creating value for sponsor companies. Their solutions aim at making access to critical data easier, providing turnkey solutions to empower sponsor companies without having to hire, maintain, and manage a large number of resources and programmers. GoBalto’s flagship product, Tracker, is a software-as-a-service clinical research platform. It enables clinical trial sponsors and research organizations to track milestones on the critical path, and provides document workflow management capabilities in a transparent, regulatory-compliant, user-friendly way.

Comprehend Clinical, also providing a cloud-based system, is serving real-time analytics across complex clinical data, independent of data source or format. It enables sponsors (mostly large pharmaceutical companies) to quickly answer questions and discover discrepancies from any device.

Clinovo is aiming at helping small to mid-sized sponsors access advanced technology in order to streamline their clinical trials. We are currently seeking funds for CloudClinica, Clinovo’s next generation Cloud-based eClinical platform. CloudClinica is an easy-to-use, pay-as-you-go platform to build and manage clinical studies from the ground up without any programming skills. CloudClinica will remove IT dependency, and allow smaller pharmaceutical, medical device, and biotechnology companies to access sophisticated eClinical systems. 

Want to learn more on the changing landscape of outsourcing? Clinovo will be sponsoring the Silicon Valley BioTalks session on on March 19^th at Onyx Pharmaceuticals, in South San Francisco. We will debate strategies and best practices to manage CROs/sponsors collaboration from different perspectives: effective communication, resource management, processes definition, and more.

• What are the different outsourcing strategies to improve study performance and reduce costs?
• What are the best practices to facilitate effective collaboration between the CRO and the sponsor’s staff?
• How do you define shared responsibilities, and what criteria should be used to decide whether to outsource??

Experienced panelists from Clinovo, Onyx Pharmaceuticals, SFSU (San Francisco State University, and BioMarin Pharmaceutical will discuss how to use data benchmarks to choose the vendor best suited to each specific study. They will touch on how to define clear responsibilities and set up expectations that are mutually agreed upon by the different parties, and will share qualitative and quantitative performance indicators to best manage the vendor/sponsor collaboration.

Visit clinovo.com/biotalks for information and registration. Let us know if you are not in the San Francisco Bay Area, the team will be providing the recording on eClinical Trends shortly after the event.

Thank you for reading!

Olivier Roth
Marketing Manager at Clinovo

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