Pharmaceutical, life sciences, and biotechnology organizations depend on critical partnerships with companies that:
Ensuring that drug safety extends across the third-party ecosystem is critical. In addition, certifying that clinical trial investigators are reporting accurately and ensuring that healthcare organization (HCOs) and healthcare professional (HCP) partners avoid non-compliant communications, activities, and off-label usage is essential for quality, safety, and protecting the brand.
Managing these risks can include initiatives such as ensuring ABAC programs are properly in place across these partnerships, eliminating manual processes when engaging with HCPs and HCOs, validating safety and quality during clinical trials, and more.
Third-party risks can lurk around many corners within these industries. These can result from supply chain delays, concentration risk, bribery and corruption, cyber attacks, and more. Regardless of the cause, third-party incidents are high across all industries. According to Aravo’s TPRM Benchmarking Survey:
Risks multiply as companies expand their extended enterprise by onboarding new suppliers to assist in critical operations, logistics and transportation, testing, and other functions. Across all industries, the number of third parties that companies engage with is growing. Organizations working with more than 10,000 third parties have increased to 25% (up from 19% in 2020). The largest percentage (30%) is in the 500-4,999 range.
Third-party risks the pharmaceutical industry can face in their vendor relationships include:
Conducting clinical trials is a necessary component of pharmaceutical and biotech manufacturing. Third parties are used in relation to lab vendors, participants, and data collection. Outsourcing these functions often helps speed up processes and lower costs, however, they bring potential reputational, compliance, and quality risks as well.
One area of focus for TPRM in this regard is to ensure that the sponsor (the organization leading the study) and any third parties understand the scope, protocol, and goals of the study, to limit any disconnect. Managing this doesn’t end with the selection of the vendors, however; organizations need to conduct monitoring throughout the projects to ensure that operations are running as expected and that there are no safety, quality, or compliance issues that could put the sponsor (or participants) at risk.
Another area to consider is the quality of the data gathered throughout and at the end of the study. Conducting ongoing monitoring of the processes and data, while also ensuring there is a thorough communication plan in place are ways to mitigate these risks. Monitoring vendor performance through contracts and SLA management, as well as KPIs are also good ways to manage these relationships.
Engaging with healthcare professionals (HCPs) and healthcare organizations (HCOs) are a tried and true method of gaining expertise and providing validation onto new or existing products and technologies. These relationships rely on physicians who back products and represent the pharma organization at events, collaborate on clinical trials, and engage in research. They also can act as spokespeople, providing education on these medicines and treatments.
These are paid relationships, and disclosure of payments is an integral component to ensure that visibility is provided into the nature of this relationship and to avoid any potential compliance issues. As with much of TPRM, managing these HCP and HCO relationships has traditionally been very manual. Yet, as relationships evolve, multiply, and risks increase, organizations need to work to make processes more efficient and engage in better TPRM automation software.
Ongoing vendor performance monitoring and vendor performance management are key to navigating these relationships while still delivering products to market on time. Some examples of ways to measure the performance of these relationships include:
A vendor service level agreement (SLA) is a set agreement between an organization and a third party on specific levels of service and functions that are expected as part of the engagement. This is an important step in engaging with a third party (like a clinical trial partner), and mutually agreeing upon specific services and areas of the relationship. An SLA does not end when the document is finished. Organizations need to consistently review vendor performance to ensure they’re meeting the terms of the SLA.
Managing vendor contracts is a critical component of TPRM programs in any industry, but especially important for pharmaceuticals. Ensuring that contract creation accurately reflects the scope and requirements of the relationship helps set a strong benchmark for the partnership. However, continuous monitoring of the vendor to ensure the terms of the contract are being upheld is necessary.
Key performance indicators (KPIs) measure the quality of service that a third party or vendor provides to an organization. For example, KPIs you could implement would be to measure vendor performance and ensure terms of SLAs are being met. Key risk indicators (KRIs) measure the risks themselves and your exposure to them as an organization.
It is a good practice to start with the end in mind; in other words, what are your goals for the relationship with this vendor or HCP, then move forward from there. Once KPIs and KRIs are set, it is important to re-visit them as continuous monitoring is performed on the vendor.
When it comes to critical operations, pharmaceutical and biotechnology organizations need confidence that their network of third-party testers and distributors can fulfill the terms of the partnership, avoid risks, and remain in compliance.
TPRM programs in this industry need to incorporate vetting, onboarding, due diligence, and continuous monitoring to protect against risks like bribery & corruption, conflicts of interest, unethical and irresponsible practices.
Doing all of this with manual processes just won’t cut it. Pharmaceutical organizations need automated, effective TPRM solutions that are scalable, robust, and contain tested platform functionality.
In order to manage risks across the entire relationship lifecycle, Aravo’s TPRM solutions provide full visibility, enhanced risk mitigation workflows, as well as integrated and accessible due diligence utilizing enhanced risk intelligence to help you manage all your pharmaceutical risks.
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