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Example Pharmacovigilance Strategy

Parexel's Safety Services are delivered with the belief that pharmacovigilance is rapidly evolving into what we have termed the "next generation of PV". Technology and availability of increasing safety data and therapeutics is consistently reshaping the delivery of pharmacovigilance services.  In an effort to assist our clients with their strategic goals in this changing environment, Parexel has developed an Integrated Solutions Framework which provides our structure for building services which support the future. The framework is based upon people, processes and technology investments and strategic changes. A high-level summary of the model is shown below.  

Using this framework, we deploy a Solutions and Account Management Director to each client account. This role is responsible for strategic thought leadership. Working with the client and the operations team, the Solutions and Account Management Director is responsible for identifying opportunities for improved performance, including but not limited to efficiencies, quality improvement, horizontal workflow linkages and developing and implementing state-of-the-art solutions. With a broad knowledge of the industry and access to the Parexel network of SMEs, the Solutions and Account Management Director brings creative, futuristic solutions to our clients.  

Two examples of our success in this area include our development of an affiliate management program and a local literature management program. 

Example 2019: The affiliate management program was developed to assist a large pharma company with simplifying and improving performance, managing staffing, costs and invoicing for their large number of affiliates. With multiple affiliates the client had difficulty attracting qualified pharmacovigilance staff in local regions. Work quality was impacted and was inconsistent from region to region and recruitment costs were high. Additionally, there were high costs related to contract and invoice management due to the high number of affiliates. 

Solution: Parexel worked with the client to develop an affiliate service program. Affiliates are offered a menu of pharmacovigilance services which are provided from our low cost India hub. Standardized templates are utilized for work consistency, and the affiliates can contract for services through as single client contract. Parexel submits a single monthly invoice to the client with services for each affiliate, and the client then coordinates fund transfers within their company finance system with the affiliates. Recruitment is no longer problematic as Parexel recruits and hires into necessary positions based upon the work requested. This program has been very successful and has grown from 24 to over 150 affiliates for this client. 

Example 2020: The local literature management program was developed to assist a large pharma company with a high cost for managing local literature review for their global program. The client experienced difficulty tracking the publications and their frequency. Local journals were reviewed in local language in each of their affiliate offices. Local staff were responsible for monitoring publications and obtaining subscriptions. Entire journals were reviewed to locate an article with potentially relevant safety information. When safety information was located, the information was then transcribed and forwarded to a centralized location for further processing, including translation as needed. All of these activities posed risks for missing safety information and high costs related to inefficiencies and duplication of efforts.

Solution: Parexel develop an end to end solution for this client. Using our library service expertise, we were able to centralize subscriptions and the monitoring of publications and their frequency in each of the required locations. We deployed our automation team to develop a tool for workflow management which also allowed journals to be screened in local language by searching for key search terms. The review tool incorporated a translation tool so that the end user could gain an understanding of the context of the abstract/article and determine if a validated translation was required for further processing. Reviews were documented in the tool for the extraction of compliance reports and data fields can be exported using E2B format into other client systems to prevent redundancy of data entry. All of the reviews are now performed in our India low cost literature excellence hub.