Pills

Overcoming the unique drug safety and regulatory challenges faced by small and medium biopharma

Leveraging an Integrated, Holistic Solution

Small- and medium-sized enterprises typically do not have the resources and expertise to establish an internal pharmacovigilance (PV) operation, as this would divert valuable time and money from product development. As a result, clinical development or regulatory groups, which are not specialized in PV, often take on the responsibility. Their potential knowledge gap means that organizations may be at risk when filing a new drug application.

Following product approval, PV takes precedence and requires dedicated, experienced professionals to manage both operations and support infrastructure. Highly skilled resources must be retained to perform functions such as safety reporting, benefit-risk evaluation, signal detection and risk management plans.

Adding to the complexity for small- and medium-sized organizations are global regulatory mandates. Across Europe and in Australia, Canada and Japan, a qualified person responsible for PV (QPPV) is required, which poses additional resource burdens.

In most cases, an optimal solution for small- and medium-sized organizations is to leverage a strategic partner that can provide end-to-end integrated regulatory, safety and PV support from clinical trials to post-marketing. A vendor such as Covance offers domain skills, including case management, medical review, aggregate reporting and safety data assessment. IT skills help to evaluate, implement and maintain technology with a centralized safety database and automation tools.  

Small Biotechs and EudraVigilance

Small biotechnology companies focus on clinical development for novel therapies using new technologies, leaving resources and experience limited in PV. Another challenge for non-EU-based companies is registration with the European Medical Agency (EMA) and EudraVigilance (EV). Many U.S.-based biotech companies know the PV regulations in the U.S. but are not aware of European processes. They may choose to invest in an experienced service provider to leverage additional expertise.

Common Regulatory and Safety-Related Pitfalls

Regulatory compliance requires standard operating procedures (SOPs) and safety management practices. Suboptimal processes and non-compliance issues can lead to higher costs through missed work, rework or low-quality output. Regulatory authorities issue warning letters for violations, and consequences can be severe.

The figure below depicts safety and regulatory activities as part of the product lifecycle. Common pitfalls for smaller sponsors include failure to:

  • Integrate safety databases for data aggregation and review
  • Develop robust SOPs and work instructions
  • Perform safety activities included in the SOPs
  • Analyze, review and document clinical safety data
  • Review and update the IB on a timely basis
  • Coordinate case submissions to regulators, ethics committees and investigator sites
  • Submit DSUR/IND annual reports per schedule and regulations
  • Manage the development of core safety information according to EU requirements
  • Ensure audit and inspection readiness at all times

People, Processes and Technology

The people factor is an essential consideration for SMEs in terms of affordability and flexibility. External vendors provide a flexible flow of qualified, competent and specialized personnel while handling spikes and boluses. Sponsors can leverage their expertise in safety, medical, clinical, biometric, regulatory and technology issues to meet quality standards and regulatory compliance – without the need for recruiting, training and retaining dedicated staff.

Developing processes for end-to-end clinical development, regulatory and PV activities is costly and laborious. Specialty outsourcing organizations can provide robust and audited systems, saving time and expense. These processes can be configured to the company’s needs and are regularly updated to accommodate changing regulatory requirements and technological advances.

Information technology is essential for a robust safety and risk management operation. Vendors can provide technology infrastructure and services, plus knowledgeable and experienced technical staff, ensuring business continuity and disaster recovery. Specialized vendors employ best-in-class systems and oversight with well-defined quality management plans, robust SLA compliance frameworks, plus metrics, analytics and reporting.

Benefits of Integrated Safety and Regulatory Solutions

The best strategy for pharmacovigilance management incorporates:

  • A holistic, customer-centric approach comprising safety, technology and advisory services
  • An integrated model ensuring regulatory compliance, quality data, product safety, lower risks and cost savings
  • An efficient study design with analysis and reporting to enhance clinical trial success
  • A PV and regulatory team that understands submission requirements
  • A single vendor offering services across end-to-end PV functions

Covance Patient Safety Solutions offers a scalable suite of integrated services, specialized clinical development plus post-marketing and regulatory expertise. This holistic solution allows small- to medium-sized organizations to focus on delivering a product that has an optimized benefit-risk profile and operations that comply with regulatory requirements to achieve commercial success.

For more information, see our white paper.

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