Contract Pharma Using Informatics to Gain Competitive Edge
It’s no secret that clinical trials have grown more complex, and that pharmaceutical companies are increasingly turning to contract research organizations (CROs) for support. In fact, by 2020, CROs are projected to handle nearly three quarters of all clinical trials. Research and Market’s New Trends in Global Clinical Development Outsourcing forecasts annual compounded growth of 9%, from $38.4 billion in 2015 to $64 billion by the end of this decade.
A 2015 Nice Insight survey also clearly demonstrates spending is escalating with CROs: The number of sponsor companies spending $10-$50 million on outsourcing reached 62% in 2014-2015 - up 24% over the previous year, and double that of 2011-2012.
Among the market drivers for seeking outside support is the need to apply big data analytics to the numerous - and growing - forms of multi-structured data being incorporated into clinical trials. These include:
- - Electronic health/medical records
- - Clinical data repositories
- - Prescription information
- - Real-world outcomes
- - PK/PD data
- - Wearable device data
- - Publicly available data repositories
Pharma and life sciences companies are struggling to keep up with data volumes, data integration, long-running analyses, and data visualization.
Leveraging various data sources – to yield a fuller, clearer picture for decision making – requires advanced informatics solutions that can integrate multivariate data and serve up informative visualizations and analysis. Such technological capabilities deliver the promise of big data to sustain drug pipelines.
Whether large, global entities or smaller, niche players, the best-in-breed CROs are focused on building out their infrastructures to effectively capture, consolidate, standardize, and visualize both operational and clinical data from multiple sources. Such real-time predictive analytics generates the business value which sponsors are looking for in their CRO partners to drive better clinical decisions.
Both CMOs and CROs continue to expand their service offerings, and are becoming technology-platform providers. Offering visual, interactive dashboards to allow for rapid decision-making and deeper examination of the data, these big data and analytics technologies become a value-add service for CROs.
McKinsey confirms this added value. It estimates that applying big data strategies can generate up to $100 billion in value annually across the U.S. healthcare system by optimizing innovation and improving the efficiency of research and clinical trials.
Informatics a Key Tool for Pharma-CRO Collaboration
Outsourcing creates a partnership between the pharmaceutical sponsor and CRO, and success requires tools that help the two collaborate effectively. Comprehensive informatics solutions can bridge sponsor and CRO, breaking down barriers and identifying the top data sources (EDC, CTMS, PV, labs, etc.) that are essential to analysis. CROs, therefore, must invest in best-of-breed platforms and technologies in order to deliver optimum data-driven decision-making capabilities to their pharma sponsors.
This includes clinical informatics to improve patient enrollment and retention, clinical data and operations review, and risk-based monitoring. Better integration of data across the development lifecycle delivers a complete pipeline picture – in real time.
While some studies indicate CROs in emerging countries are stealing market share, those in developed countries still command nearly 67 percent of the global market. This means CROs need the technology to deliver results around the globe in near-real time, without any latency issues
In a high-growth, hyper-competitive CRO market, informatics solutions can distinguish the leaders from everyone else.
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