Drug Safety Outsourcing: Enhancing Customer Experience

The increased prices of drug research and development as well as post-market surveillance must be counterbalanced in part by wiser, sleeker, greater agility that saves money without compromising quality.

Outsourcing can be an important part of the solution if companies work hard to find the right partner, choose the best contracting agreement, and pursue a solid relationship model.

Primary outsourcing strategies

• Product safety regulations have increased the demand for pharmacovigilance capacity and expertise. 
• The atmosphere of drug safety outsourcing is changing to include more complex activities like signal analysis, risk assessment and management, and risk analysis planning.
• Many pharmaceutical and biotechnology companies are reconsidering their drug safety and patient safety outsourcing strategies.
• The need for outsourcing varies greatly between companies and is influenced by a variety of variables, such as the size of the company, the extent of its drug safety and patient safety resources, and the company’s existing permits or development collaborations.
• Because emerging and small biotech firms typically lack drug safety departments, all safety services are outsourced.
• Mid-sized companies typically have the resources and expertise to meet the global drug safety environment’s demands. However, they necessitate assistance in meeting the fluctuating resource requirements caused by a changing product pipeline. 
• They are also geographically limited and frequently require additional assistance in unrepresented countries.
• Large corporations have extensive departments with global facilities and databases; they frequently outsource responsibilities to cut costs. Choosing a vendor necessitates some research and planning.

Companies should take the following preliminary steps:

• Establish clear relationship goals and objectives. This includes defining the tasks to be contracted for and weighing the available expertise against the level and number of resources required.

Outsourcing can be a positive experience if the sponsor and vendor communicate openly and promptly address issues. Such circumstances necessitate extreme flexibility on the part of both parties.

• Conduct thorough research. Companies should check the references of the provider to gain insight into actual past performance. A track record of regulatory compliance and low nonconformity rates usually indicates the presence of a strong quality management system.

Examine the business models available for the requested service. Key factors influencing model selection include intricacies and variations, the amount of work involved, and the length of the project.

Outsourcing Model Types

• Model-based on resources: A team is staffed to meet the maximum projected volume of a program. This is a less expensive option suitable for programs with relatively stable and predictable workloads.

• Activity-based model: When the resourcing strategy is projected based on accurate forecasting, this model provides flexibility while also containing costs. It allows for resources to be partially allocated to support additional programs or clients.

• Blended/transformational model: This is tailored to the company’s specific needs and provides a cost-effective team to support a baseline workload as well as services on a per-unit basis to support periods of high volume.

Making your relationship work

Sponsor-outsourcing partner relationships are built on well-defined contractual agreements that are managed within a configuration that matches the scope of work. To achieve efficient and effective collaboration, the following steps must be taken:

Roles and responsibilities should be defined, establish communication pathways and escalation procedures, create a governance structure, and develop contingency plans for both parties at the start of the alliance.

The board should hold regular meetings to assess the ongoing relationship and operations. forming an oversight committee composed of executives from both stakeholders in addition to their respective project teams.

Making investments in face-to-face management sessions to ensure that processes remain aligned, issues are resolved, contract changes are managed, and upgrades are identified is key to achieving organizational success.

Although such actions have an impact on the project budget, they are beneficial in the long run. Resources can be optimized for the greatest possible cost efficiencies with a joint commitment, shared values, high trust, suitable leadership, allied core strengths, and positive company outlooks. The extent and quality of collaboration will determine success.

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