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Disrupting Clinical Operations with CRO Strategic Partnerships

Craig Morgan
Head of Marketing, Study Startup

In response to tighter margins, globalization and increasing regulatory complexity, sponsors have been embracing an outsourcing model using Contract Research Organizations (CROs) to conduct scientific services for all phases of clinical research.

A primary motivator driving this trend is the expected benefits to be gained from external specialization, allowing drug makers to focus on core competencies. The pace of scientific discovery requires drug companies to utilize cutting-edge techniques and subject expertise across a vast breadth of therapeutic specialties. Outsourcing provides this access with none of the costly in-house investment. Beyond offering market agility and introducing fair market price efficiencies, strategic outsourcing also aims to shorten the time to market entry and with it recoupment of R&D expenditure for sponsors. Sponsors must continuously fight an uphill battle to minimize complexity, streamline business processes and workflows, ensure compliance and increase efficiencies at every level. Cue the rise of cloud-based technology solutions.

Technology as Opportunity

CROs are poised to transition from a pay-per-service provider to a long-term strategic partner within the industry. The benefits of this approach will not come from simply increasing relationships with CROs, but in how sponsors leverage those relationships to introduce innovation into their workflows. Both see optimized outsourcing models as the key to sustained mutual growth, but until recently, it was still unclear how industry innovation would take shape.

Enter the cloud. The benefits of which can be seen in another industry charged with managing complex global supply chains, strict international regulatory guidelines, consumer safety monitoring, exorbitant delay costs, and huge data management needs - the food manufacturing industry. As food companies implemented cloud solutions, they reported improvements in operating processes, cost savings, and an increase in product quality resulting from data-driven decisions. Those insights were possible due to enhancements in data integration, automation, and improved predictive analytics. The drug development industry is ripe for adaptation and process optimization from cloud-based software.

With the advent of cloud-based software, collaboration and analytics have the potential to revolutionize the traditional clinical trial workflow. Data is no longer locked into physical devices, infrastructure, and organizational silos, making it easier to work with partners. Sharing documents, workflows and common metrics across organizational boundaries increases communication efficiency and reduces cycle times. As a result, technology adoption is quickly becoming a key differentiator for CROs, as sponsors increasingly look for partners who have the infrastructure in place to minimize costs and streamline collaboration. CROs are, in turn, striving to position themselves as technology innovators, but the challenge of disconnected, antiquated systems and lack of standardization continues to plague the industry. According to David Blackman, PPD’s Business Innovation Director, “The trend of biopharma companies and CROs developing their technology strategies and roadmaps independently has resulted in an enterprise information portfolio that is made up of various disparate data warehouse and storage areas. This disconnected approach is magnified when clients that work with multiple CROs receive both patient and operation data/reports in each of their partners’ formats, causing clients to manage their studies or programs through these non-standardized processes.” The time is right for the adoption of cloud-based technology solutions that, not only streamline collaboration between CROs and sponsors, but also standardize the data views and workflows from study to study. This will save time and promote efficiencies across the clinical research value chain.

An Innovative Partnership

Beyond just technology, this new opportunity for innovation is borne out of the realization that leading CROs are sitting on a wealth of actionable data and expertise which can be leveraged into data driven decision making on a large scale, from starting clinical trials through to execution. CROs have the benefit of years of cross-sectional data which could enable meaningful predictive analytics designed to mitigate risk and predict success. Data on historical trends, trial cost effectiveness, patient enrollment and retention, screen failure rates, and site performance, are invaluable in framing out the early stages of study startup, for example. Comparative data on total principal investigator cost per patient and the total site cost per patient are key metrics in evaluating cost performance of a study and projecting financial risks in future trials. This benchmarking analysis has traditionally been a painstaking and inexact task with many moving parts, causing costly delays before the actual clinical trial can even begin. The Tufts Center for the Study of Drug Development estimates that it takes an average of eight months to reach the site initiation phase in clinical development. Expediting or improving this workflow is possible with aggregated insights and data analysis provided by a partner who specializes in site identification.

The data, technology, and scientific knowledge offered by leading CROs makes them primed to step into a new role as strategic partner.

A Strategy for Strategic Partners

With so much at stake, where do you start when considering the right long-term, strategic CRO partner? Attributes to look for in 'best-in-class' strategic partners:

  • Early Adoption of Cloud Systems and eClinical Tools: CROs who embraced new technology early are best poised to benefit from the transition. As a strategic partner, they will not only have mastered the benefits of eClinical tools and cloud-based systems to optimize process efficiency, they will be open to innovative approaches going forward.
     
  • Optimized Analytics: CROs making the most of data by looking for actionable trends in enrollment, site performance, trial data, cycle time, monitoring, cost ratio, and screening can offer more accurate predictive modeling. CROs who specialize in global site identification analysis provide a significant advantage for sponsors.
     
  • Integrated Data Management: Cloud-based technology platforms should make accessing data easier. Avoid CROs who can only provide raw trial data in a single form or after a specific request, this may translate into costly delays. Best-in-class cloud technologies should offer multiple ways to access data in real-time with build-in reporting functions. CROs who specialize in data management services often perform better by regulatory and efficiency standards.
     
  • Subject Expertise: Utilizing CROs expertise for therapies allows sponsors to benefit from the learnings, successes, and failures of others. Additionally, leading CROs will offer highly trained staff at all levels of trial administration, including monitors and site managers. This is particularly valuable in navigating the increasing complexity of global regulatory guidelines.
     
  • Relationships: Many leading CROs have strong relationships with sites (or may own site networks), investigators, and local regulatory agencies. CROs with regional offices offer increased access to local patient populations and cultural knowledge. These make them a valuable ally in shortening the study startup phase and help ensure trial success. By leveraging locally based knowledge through CRO employees, sponsors can improve enrollment and site activation time.
     
  • Experts in Risk Based Monitoring (RBM): If implemented correctly, RBM is a way to reduce the costs of traditional, entirely on-site monitoring program. Experienced CROs who specialize in RBM can offer cost savings and innovation by developing an appropriate risk-management strategy for each study in question.

Conclusion

The cloud has changed the way we collaborate and share information. While subject matter expertise, relationships, and qualifications will always be critical for CRO selection, they are simply not sufficient criteria for sponsors who need to make a step change in efficiency. The next competitive battleground for CROs is technology maturity and infrastructure. Embracing this approach will require collaboration between regulatory agencies, sponsors, CROs, academic institutions, and technology companies alike. Such collaborative models will breakdown the traditional boundaries amongst organizations and functional silos, empowering stakeholders, driving process efficiencies and ultimately accelerating the delivery of approved therapies to patients in need.

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