Applied Clinical Trials
The best relationships between sponsors and contractors are those that are well defined from the outset.
Outsourced safety services in the past were rather limited. Traditionally, pharmaceutical companies outsourced SAE/ADR management, pharmacoepidemiology studies, and individual consultancy. Concerns about confidentiality, data security, and liability in cases of regulatory non-compliance were—and still are—important factors against outsourcing. However, the increasing demand for pharmacovigilance capacity and expertise cannot always be satisfied in-house, whether constrained by limited resources, or a lack of appropriate infrastructure or regional presence. Consequently, the changing industrial and regulatory environment leads to re-evaluation of the advantages and disadvantages of outsourcing.
The benefits of outsourcing in general also hold true for pharmacovigilance services. Fixed resource costs are converted into flexible workload-oriented costs. In the outsourcing model, pharmaceutical and biotech companies reduce costs because significantly less effort is needed for recruitment, management, and training of staff. Since safety concerns about marketed medicinal products resulted in stricter regulatory requirements, the job market for hiring experienced safety personnel has become highly competitive. The special benefits of outsourcing pharmacovigilance services include access to unique expertise, intellectual property, and multidisciplinary knowledge at the time they are actually needed. Because the contracted experts are external, they can provide an unbiased view. This impartiality can be of special value in a decision-making process.
What services are outsourced?
Nowadays, all of these tasks are outsourced. In addition, sponsor companies ask for specialized pharmacovigilance services, such as: pharmacovigilance audits to prepare for inspections; delegation of the role of a qualified person for pharmacovigilance; development of product information; and process design and SOP generation. With the growing demand of regulators for risk management programs, sponsors also seek support in the development of such programs. Although in general all tasks related to pharmacovigilance and risk management are outsourced, the needs of individual companies vary significantly. Company size, the size of the pharmacovigilance department and existing license or development partnerships influence the outsourcing decisions.
Small biotech companies typically have no drug safety department and therefore have to outsource all routine safety services including the safety database. Only high level activities including analysis and decision making are kept in-house. Internal safety and risk management expertise as well as the resources to manage and control the vendor are many times limited. It is often this conflict between the sponsor's limited safety and risk management expertise; and being overzealous in the decision making process, which causes the most dissatisfaction for both parties.
Mid-sized pharma companies generally have the knowledge and resources to cater to the demands of the global pharmacovigilance environment. Typically they require additional support to meet fluctuating resource needs associated with a changing product development pipeline. For example, support will be needed to cope with medium-term resource challenges, such as increased SAE volume due to a new clinical program. They also have limited geographic coverage and often require additional support in unrepresented countries.
Large pharma companies have large pharmacovigilance departments with a global safety database as well as global infrastructure, knowledge, and expertise. Outsourcing occurs mainly for low-cost solutions and sometimes to support peak workloads. However, the areas of concern for low-cost off-shoring and outsourcing are quality issues and regulatory non-compliance. It is pertinent to maintain the necessary oversight and engagement with the outsourcing partners or the vendors. Stepping in early to mitigate or control an issue before it gets out of hand is something large companies need to be aware of and plan for.
Making the provider selection
Pharmacovigilance activities which are outsourced vary significantly. The range of contracted services is reflected by the spectrum of safety service providers: individual consultants, specialty clinical research organizations (CROs), large "full-service" CROs, and global service providers under the umbrella of business process outsourcing. To achieve a successful cooperative relationship, it is crucial to select the best provider for the actual need. When considering outsourcing of medium to large-scale routine work, pharmaceutical companies should also take into account that shifting work to an external provider can free up internal resources for the increasing demands of quality control and/or for more intellectual tasks, such as signal detection and/or development of risk management plans early on.
Considerations that affect provider selection: What services will be outsourced first? What are the future outsourcing plans? Is this the first in a series of contracts for similar or different services? Is this a one-time request for consultancy? How are various outsourced services linked to each other?
Outsourcing pharmacovigilance activities is a standard business practice in a rapidly expanding market segment. Irrespective of the required type of support, the outcome will be a positive experience if the following rules are adhered to: the service provider has the qualification for the pharmacovigilance service; the contractual agreement includes well defined responsibilities; and communication as well as escalation paths are clearly defined at project start. Regardless of the level of sponsor involvement, consensus has to be established and maintained—cooperation in pharmacovigilance remains a collaborative effort.
Sabine Richter, PhD, is Vice President, Safety and Risk Management at PRA, e-mail: RichterSabine@PRAIntl.com.