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Healthcare systems and researchers need to curate and standardize clinical trial data to arrive at meaningful analyses. Despite being mission-critical, management is a labor-intensive process. Moreover, overwhelming regulatory requirements and staffing shortages are getting in the way of curating high-quality data.
Scalable and sustainable data management solutions are crucial to meeting clinical research and trial goals. As the pressure increases, leaders can turn to business process outsourcing (BPO) to access well-versed experts.
This article discusses how BPO can be an advantageous clinical trial data management strategy.
BPO Opportunities in Clinical Trial Data Management
The rising volume of complicated data, growing demand for clinical trials, and persistent shortage of skilled workers drive research organizations to hire reputable outsourcing partners. These third-party companies handle the backlog of curation and data entry tasks to minimize costs and provide real-time data.
According to WCG’s Clinical Research Trends and Insights for 2023 report, human capital remains crucial, and the knowledge of data experts continues to be in high demand. The report also stated that the foremost operational challenges impacting clinical trial data management are as follows:
- Staffing (51.9%)
- Trial enrollment (49.4%)
- Burdens brought by remote monitoring and audits (33.5%)
- Research contracts and budgets (33.5%)
In the Pharma Intelligence report that Oracle sponsored, 95% of data management experts said that collecting, cleaning, and transforming data for clinical trials must be done by hand. Clinical trial data management teams often spend more time cleaning data than analyzing it.
Outsourcing can help solve the challenges faced by data management experts. As such, the global clinical trial outsourcing market will reach $67.62 billion by 2030. Here are some ways outsourcing can help:
- Service providers can offer artificial intelligence (AI) and machine learning (ML) modeling to create and test data sets to support clinical predictive modeling.
- Third-party workers handle data collection, curation, and analysis from various sources to enhance data quality.
- BPO firms use centralized data governance and protocol management to monitor and report on compliance.
Benefits of Outsourced Clinical Trial Data Management
Clinical data management (CDM) is critical to the clinical trial and research process. It involves gathering, cleaning, and managing clinical trial data based on industry best practices and regulatory guidelines.
What is BPO in healthcare? It is the process of outsourcing healthcare areas to support medical institutions or clinical research teams. BPO in clinical trial data management proves to be highly effective. Here are a few of its benefits:
- Outsourcing means you need not hire, train, or manage data experts as part of your in-house research and development team.
- The strategy gives you the ability to quickly scale up and scale down.
- BPO firms help streamline bottlenecks and significantly reduce time to market.
- Third-party providers offer better community engagement and a “patient-centric” approach.
- Service providers specialize in data management, statistical analysis, and clinical data reporting.
- Working with an external team is critical for efficiently allocating resources and saving money and time.
- The right vendor adds more oversight and quality assurance to your data management.
Challenges of Outsourcing Clinical Trial Data Management
The overall benefits of outsourced clinical trial data management services vary depending on the goals and needs of your organization. Be sure to consider potential BPO opportunities and examine the following risks before signing an outsourcing agreement:
- Loss of control. Outsourcing entails relying on a third-party vendor for a service. As such, it may result in losing control over the standards and quality of the outsourced data management function.
- Coordination issues. Outsourcing may give rise to coordination issues between different providers, especially if you are outsourcing to various vendors or firms in other countries.
- Difficulty managing performance. Outsourcing may make it harder to guarantee that the team meets your expectations and standards.
- Transparency problems. If you cannot talk to the service provider’s management team, you will not know how they spend their time or get a straight answer regarding their progress.
You can manage these challenges when you partner with the right service provider. Choosing the right BPO partner for clinical trial data management is crucial to outsourcing success. Consider the firm’s clinical data management technologies and how they affect data handling.
For example, data management software enhances transparency and streamlines collaboration. On the other hand, automation solutions supported by AI, ML, and natural language processing (NLP) maximize accuracy.
Another vital element of a successful BPO partnership is the provider’s flexibility with your requirements. Your potential partner should also use robust security protocols to protect the trial data.
Lastly, if you have already gathered data from past trials and need to integrate them into the system, check if the vendor offers data extraction. Data extraction is a complex process that must be done without errors. Verify if the provider can migrate extracted data into the system repository for better security.
Choosing the Right Outsourcing Model for Clinical Trial Data Management
BPO models for clinical trial data management have changed to accommodate the sector’s growing needs. Biotech companies seek to offload functions to access expertise and capabilities while spending more in-house resources on vital business. This leads to operational efficiencies and growth for biotech initiatives while reducing the time and cost of drug development.
Third-party research organizations and BPO companies use customizable outsourcing models to fulfill the client’s needs. These structures range from offering full-service capabilities to offloading specific functional services. Here are some common models:
- Full-service outsourcing (FSO) involves the complete outsourcing of most or all tasks for clinical trial data management on a trial-by-trial basis. This approach reduces management burden, making it ideal for clients lacking data management expertise or the resources and knowledge to monitor and oversee data management.
- A functional service provider (FSP) involves outsourcing all or a portion of one or more functions, such as data monitoring and management. The FSP approach offers access to expertise that is not readily available internally and resource flexibility.
- The hybrid model combines elements of the FSP and FSO models in a bespoke manner. It enhances flexibility and gives each client access to complementary expertise, as required.
When picking the right outsourcing model, consider the following:
- An FSP and hybrid model work best when looking for flexibility and scalability.
- The FSP model may be used as an alternative for in-house teams.
- If you lack the expertise and resources, consider outsourcing the entire data management process to an FSO model.
- Consider the level of internal knowledge, experience, and staffing you need.
The Bottom Line
Companies must choose a BPO partner with the facilities and infrastructure to meet their product type and allow them to finish the task within the agreed timeline. Choosing a partner with a proven track record, measurable performance metrics, and a transparent organizational model empowers pharmaceutical companies to be more efficient.
Are you curious about the ins and outs of outsourcing? Let’s connect to discuss BPO solutions to support your clinical trial data management!
