Surge in Clinical Outsourcing Continues
Demands today and into the next decade for more and better therapies is placing unprecedented pressure on the global pharmaceutical industry, and it is estimated that by 2020, up to three quarters of clinical trials are likely to be performed by CROs.1 Innovative discovery methodology has increased the number of smaller, emerging biopharma organizations who are keen to develop their products to sell, co-license or take to regulatory approval. Regulatory requirements are becoming more stringent, and focus is being placed on data quality, integrity, reliability, and traceability like never before. Furthermore, a range of incentives are being offered by the FDA to encourage the biopharmaceutical industry to focus on rare, unmet health needs in addition to the more common therapeutic areas that offer potential blockbuster products. All this has led to a greater need for sponsors, CROs and technology vendors to join together to develop more efficient and effective ways to manage clinical research.
Convergence of Data Sciences
As clinical outsourcing grows, sponsors, CROs and technology vendors are thinking about how the availability of new data collection and analytics solutions can be leveraged in clinical research.
Real World Evidence: There is an increase in the convergence of life sciences and healthcare data. Real World Evidence (RWE) research is an increasingly important component of biopharmaceutical product development and commercialization. Advances in technology have led to the increased use of wearable devices that capture patient data in real-time, which has led to the trend in mHealth (Mobile Health) solutions. Clinical researchers are looking for ways to collect, manage and use this data, and also how to scale to cope with the increased variety and volume of data being generated.
Precision Medicine: Precision medicine presents a clear and targeted path for both outsourcing partners and sponsors to achieve faster, more reliable submissions, improved approval rates, and accelerated time-to-market programs for new pharmaceuticals. By focusing on biomarker innovative technologies, clinical research teams can realize immediate increases in trial efficiency, as well as long term ROI and patient centricity benefits.
Data Platform Innovation Revolution: The movement to cloud-based software enables multiple sources of data to feed into a single platform that can serve as a single source of truth for improved clinical and safety data insight. This consolidated view has optimized clinical trial collaboration between sponsors, CROs and other partners. With the goal to accelerate data collection, cleansing, integration and analysis from source to submission, integrated data platforms offer benefits which include:
- Increased Flexibility to support adaptive trials that introduce strategies such as Risk Based Monitoring.
- A Comprehensive View of data from multiple and often disparate sources into one ‘single source of truth’, with transparent lineage, for better and faster decision making.
- Features Which Improve Data Security by helping to ensure that blinding / unblinding requirements are maintained for the many stakeholders involved (including sites, sponsors, CROs, vendors, etc.), thereby furthering data integrity, without introducing bias.
- Real time dashboards provide immediate visibility into trial conduct activity that allows internal monitoring by the organization performing the day-to-day activities, and also external monitoring by the outsourcing organization.
- Improved Patient Stratification is now possible with the ability to screen large investigator and patient databases, which allows for personalized therapies, expedited trial initiation, and reduced patient recruitment costs.
Precision Partnership: The Triple Clinical Partnership Alliance Model
To meet all of these demands and take advantage of new ways to conduct clinical trials, sponsors are partnering with their CRO service providers and technology vendors to leverage innovative technology and practices.
The CRO-sponsor partnership model is moving away from single task-based services, and towards more strategic services that align around the science that ultimately optimizes clinical development. To respond to this trend, CROs are developing strategic alliances with technology vendors to optimize their service delivery capabilities to meet the ever-evolving industry needs. This enables the sponsor to migrate its CRO relationship from a tactical, contract-by-contract, task-based outsourcing process, to a more strategic partnership. A triple strategic alliance between the sponsor, CRO and technology vendor sets the stage to grow opportunities that combine the resources, processes, and tools of all parties to compete successfully in the marketplace, and add value to clinical development.
To support this new strategic model, technology needs to deliver on the promise to provide data visibility for all stakeholders by accelerating trial performance across three key milestones:
1.Study Start: Get to First Patient In (FPI) Faster
CROs are now able to maximize clinical data intelligence to accelerate study start-up, as quickly as 2-4 weeks with the help of flexible cloud-based software.2 Certification programs are available to ensure skills are up-to-date with best-of-breed practices.
2. Study Enrollment and Get to Lock Faster
Streamlined workflows and high performance patient stratification solutions support identification of suitable patients for clinical trials, thereby improving enrollment rates. In addition, agile, real-time analytics facilitate a game-changing conversation between all three parties around critical data-driven decision making, including enrollment, FPI to Last Patient In (LPI), and locking of site data within minutes.
3. Study Close: Get from Source to Submission Faster
Automated data cleansing and transformation capabilities reduce traditional time-consuming manual processes that are needed to load, track, transform, and clean trial data from multiple sources.
Conclusion
The convergence of life sciences and healthcare data, and the ever increasing use of wearable devices by patients have led to a need for better and faster management of all available disparate data, and clinical research stakeholders must be able to scale quickly to cope with the increased volumes of data being generated. This in turn leads to a need for tighter partnerships between sponsors, CROs and technology providers to better manage, analyze, and make use of the data as part of ongoing and future clinical development activities.
Today’s cloud-based partnership solutions provide clarity with activity based modeling that gives financial and predictable reporting, allowing the data to tell the story. The result is a greater level of communication and clearer data science and analytics for executive decision making power that enables better outcomes for all. Outcomes include streamlined clinical programs, reduced trial costs and bringing safe and effective drugs to market sooner.
References
- New Trends in the 2015 Global Clinical Development Outsourcing Market, PR Newswire (http://prn.to/2jyJrO2)
- Oracle Health Sciences InForm Delivers More Study Builds in < 4 Weeks (http://bit.ly/2iAsDlq)