In the Life Sciences industry, many organizations utilize third parties and multiple vendors to assist with compliance. Results from the AHM and MeetingsNet Healthcare Professional Meetings and Engagements 2016 Industry Benchmarking Study* revealed that 56% of the respondent organizations use a hybrid model of some internal departments and some outsourced to other third party vendors.
The third party or vendor is a critical component in the success of the compliance process. This blog aims to help the Life Sciences industry not only understand the role of the third party but also to provide recommendations on ways to best work with third parties and vendors in assisting organizations with their compliance processes.
*The full study is available here.
What Unique Perspective Can the Third Party or Vendor Provide?
A third party or vendor brings a unique perspective regarding compliance to their clients due to the very nature of working with multiple clients, each with a different process, policy, and interpretation of various state, federal, and international guidelines. This unique perspective can provide valuable guidance, benchmarking, and business intelligence, which often increases trust and credibility in the third party. It allows the third party to position themselves as a trusted advisor and leader in the Life Sciences industry. Third parties and vendors can lead the discussion on compliance at industry educational events and serve as thought leaders and subject matter experts in compliance.
What Are the Challenges to the Third Party or Vendor?
There are challenges that the third party or vendor confronts as organizations outsource the various components of the compliance process. In Part 1 of this blog series we highlighted that:
- 72% of respondents indicated multiple, disparate systems for the capture and reporting of data was their biggest problem. This, too, is a challenge for the third-party or vendor. Often they must navigate multiple systems for the approval process, including collection of healthcare professional (HCP) spending and for reporting purposes.
- 48% of respondents indicated multiple vendors handling their tracking and reporting of HCP data was a challenge. Third parties are also challenged in working with different vendors in which the processes and knowledge of policy and client interpretation may be different.
Additional challenges may include:
- An increase in the number of clients asking third parties or vendors to have a financial stake in the accuracy and timeliness of data being entered and reported. This may cause friction in the relationship if the expectation was not set initially or may add additional risk to the third party.
- Condensed timeframes required to collect and report accurate data, which causes undue stress and pressure and can lead to errors and unforeseen budget increases.
- Data provided by the various vendors may not be consistent in format or organized in a manner that is easily transcribed or uploaded into multiple systems. This may result in additional fees or increased staff hours that were not anticipated or allocated in the approved budget.
- HCP dissatisfaction towards the third party or vendor due to lack in communication or clear process/policy from the client.
Mitigating the Risk to Their Client—How Can They Help?
As an organization is selecting a third party or vendor to assist with compliance, keep in mind that third parties and vendors often need to adjust quickly to meet or exceed client expectations. A successful working relationship between client and vendor includes honest, open feedback as well as expectation and goal setting at the beginning of a project. Success in assisting the client with compliance begins with identifying and understanding the key stakeholders and parties. As mentioned in Part 1 of this blog series, different organizations place the responsibility of compliance in various business units and parts of the organization. Each organization needs to determine what is best for it. The third party or vendor will have the most success when they have a firm grasp on the organization’s process, policy, and key players. Following are a few recommendations and qualities to look for when selecting the right third party or vendor for compliance needs.
The third part or vendor:
- Keeps abreast on all industry regulations, including local and global compliance regulations, and cultivates on-staff subject matter experts in compliance process and policy.
- Attends industry education, speaking engagements, business intelligence reporting, and benchmarking to continually provide innovative solutions and proactive ideas for Life Sciences organizations’ compliance reporting and analysis needs.
- Participates in regular meetings with key stakeholders regarding compliance, and serves as a resource to internal staff and key stakeholders.
- Provides multiple technology and service solutions to meet the organization’s end-to-end compliance needs including approvals, transfer of value data, and reporting capabilities.
- Aligns their goals and objectives regarding compliance with the organization, understands the corporate culture, and customizes solutions to meet the organization’s needs.
AHM has a suite of end-to-end single-platform solutions to help ensure organizations are compliant in all HCP interactions. For more information, please visit: https://www.ahmdirect.com/.
Check back in at AHM Voice to read Part 3 in this series, which will look at the perspectives on compliance from the HCP (physician), and how HCPs can contribute to successful compliance for an organization while simultaneously focusing on patient needs.
Lisa Keilty, Global VP of Compliance and Strategic Solutions, AHM
Lisa joined AHM after serving as founder of the Compliance Consulting firm PMC2 and spending over 26 years in the life sciences and meeting management industry. Leading such organizations as Pfizer, Bristol Myers Squibb and Biogen Idec through numerous international projects, financial transparency and reporting requirements, Lisa’s industry expertise has saved Life Sciences and Meeting Management organizations over 30 million dollars. As a member of the Business Development team, Lisa’s primary focus will be Thought Leadership, Demand Generation and Solution Design.