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With the implementation of my country's "Quality Management Practice for Pharmacovigilance" (GVP), pharmacovigilance work has gradually attracted the attention of pharmaceutical companies, which gave birth to the rise of pharmacovigilance outsourcing business. Due to the fact that the current pharmacovigilance outsourcing (PV Outsourcing Service, PVO) service industry in China is still in its infancy, and many rules and standards have not yet been formed, both the entrusting party and the entrusting party (hereinafter referred to as service providers) have many pain points. With the continuous popularization and deepening of the pharmacovigilance system, the understanding of pharmacovigilance by all parties in the pharmaceutical industry has gradually deepened, and the pharmacovigilance outsourcing service has gradually become standardized.

The outsourcing market is growing significantly

Due to the shortage of human resources or personnel capacity, some clinical trial sponsors and marketing authorization holders outsourced certain activities of pharmacovigilance work to third-party service providers, and the pharmacovigilance outsourcing service came into being.

Under the background of continuous improvement of relevant laws and regulations on pharmacovigilance, more and more third-party companies are engaged in full-time pharmacovigilance services and become a new force in the field of pharmacovigilance; at the same time, some CRO companies that originally only focused on clinical operations are also expanding their original Pharmacovigilance Team and Line of Practice.

According to the 2021-2028 global pharmacovigilance (internal/contract outsourcing) market size share and trend analysis report released by Business Wire, the global pharmacovigilance outsourcing market is expected to reach US$14.95 billion in 2028 % compound annual growth rate. In China, driven by both the pharmaceutical policy and the demand for drug research and development, the market size of the pharmacovigilance industry continues to grow, and the outsourcing service market will also see an inflection point of growth. According to the report of the Head Leopard Research Institute, the market size of the domestic pharmacovigilance industry has been rapidly expanded since 2019. It is expected that from 2019 to 2023, the market size of the pharmacovigilance industry will increase from 170 million yuan to 1.06 billion yuan, with a compound annual growth rate of 44.2. %; the penetration rate of pharmacovigilance outsourcing services will achieve a comprehensive increase in 2022, and the compound growth rate of the market scale from 2021 to 2024 will reach 37.5%.

PVO services can be divided into two categories: business process outsourcing (BPO) and pharmacovigilance system outsourcing (PV System Outsourcing, PVSO).

BPO service is the current mainstream method of PVO service, that is, according to the requirements of customers, the collection, processing, submission and report writing of pharmacovigilance data are carried out. Such outsourced work is often human-related and focused on process execution. In practice, since pharmaceutical companies are more familiar with CRO services, BPO services will also be incorporated into CRO services.

The most important outsourcing of pharmacovigilance activities during clinical trials is data/information processing. Common service items include the collection and entry of safety information, medical review, and submission of clinical trials. In the post-marketing pharmacovigilance activities, the holder chooses to outsource services including call center, literature search, post-marketing report processing and PSUR (Periodic Safety Update Report) writing, etc., in order to meet the most basic work requirements of pharmacovigilance .

The core and main point of pharmacovigilance work is to establish a pharmacovigilance system and maintain the compliance of the system. Since the pharmacovigilance work of most domestic pharmaceutical companies is still in its infancy, pharmaceutical companies will also consider outsourcing when establishing a pharmacovigilance system or pharmacovigilance audit, that is, pharmacovigilance system outsourcing (PVSO). PVSO service providers need to provide consulting and audit work to help companies establish and improve their pharmacovigilance system to meet GVP requirements, so they need relatively more senior professionals to implement. At present, there are few PVSO service providers in the industry. With the increasing number of pharmacovigilance inspections by regulatory authorities, pharmaceutical companies will pay more attention to this work, and it is expected that PVSO service providers will gradually increase.

For pharmaceutical companies, pharmaceutical companies need to clarify whether the work they outsource is the specific work of pharmacovigilance they perform, or whether they focus on the establishment and improvement of the system. PVO service providers also need to understand their positioning and what form of outsourcing (BPO/CRO, PVSO or both) to offer.

From start to professional

At present, most PVO service providers have not reached the standards of professional service companies, and customer satisfaction is generally not high. The specific performance is that there is huge information opacity and inconsistent standards between service providers and customers.

There are a lot of trivial details in the work of pharmacovigilance: how many reports are processed, what is the timely rate of submission of reports, whether there is information omission, how strong the training is, whether the SOP is updated in time, etc. Communication on relevant issues will increase the workload of both the client and the service provider, thereby increasing the cost of the service provider. According to statistics, more than 20% of the workload of service providers is to count and report the above-mentioned work results. Even so, it is difficult to achieve a completely consistent understanding of the deliverables and the execution process by both parties, which in turn may lead to the failure of the service provider's efforts to be recognized, the inability to receive effective feedback from the entrusting party, and the difficulty in truly improving the quality of work.

At the same time, there is a huge human resource gap in the field of pharmacovigilance: most of the pharmacovigilance personnel are still engaged in relatively basic and repetitive professional work, and there is a shortage of excellent and senior pharmacovigilance personnel. Almost all service providers are faced with the challenge of high turnover rate. Junior employees will choose to change jobs when they reach a certain level, and only a small number of them have the opportunity to be promoted to management positions or other senior positions.

All in all, in the process of the development of the PVO industry from the initial stage to the professional service, the entrusting party should strengthen the risk management and control of outsourcing by improving the outsourcing contract, establishing the information communication mechanism, and strengthening the audit and management work. For service providers who undertake BPO or PVSO work, other service providers should be selected to conduct audits to avoid the situation of "acting as both athletes and referees".

The future direction is automation and digitization

How can PVO service providers achieve professional development? How much work can be standardized? How to achieve transparency in the implementation process and results, and build and continue to deepen the trust of both parties?

The author believes that digitalization can solve these problems. Digitization/digital economy has become the hottest and most important topic in current economic development. The essence of digital transformation is to use technology to solve real problems. The problems that need to be solved in pharmacovigilance are the discovery, evaluation and understanding of safety problems, and ultimately prevention and control of the recurrence of safety problems, so as to realize the vigilance of drug safety. Whether it is the discovery of problems from data collection and processing, or the final prevention and control, it is necessary to continuously improve efficiency. Using digital methods to transform current practices can achieve efficient pharmacovigilance work.

The key to the success of digital transformation is that practitioners must understand both business and technology, and realize the integration of business and technology, so as to use technology to solve business problems. The integration of business and technology is the most challenging part in the process of digital transformation, and this is also the method that all PVO companies are looking for. Leading pharmacovigilance practitioners need to imagine what pharmacovigilance will look like in the future when all digitalization is realized, and together with information technology experts, step by step to realize the replacement of human by machine and digital decision-making (intelligence). ).

It is foreseeable that in the future, the pharmacovigilance outsourcing service will introduce numerous automated and digital tools to realize the transparency of the service process and the standardization of output results, and the quality and value of delivery will be higher and higher.