The principal role of pharmaceutical and life sciences process coordination services is the guidance of organizational assets through review and approval while adhering to industry best practices and organizational processes. These service providers also work in partnership with project owners, agencies and reviewers to recognize process gaps and bottlenecks while keeping processes compliant.
Process Management Services
Pharma process management coordinators are highly trained and have an in-depth understanding of all content-review areas, including SOP management, process optimization and FDA regulations. Their expertise in every major content management platform also allows them to assist organizations in quick method integration.
The objective of coordinators and support staff is process oversight and management, allowing life sciences organizations to dedicate attention to product development.
Services include:
- Creation, management and distribution for agendas
- Pre-review quality assessment
- Facilitation of review meetings
- Schedule management
- Document reconciliation and annotation
- Proofreading and editorial review
- Document lifecycle management
- Document expiry management and archival
- Production coordination
On-Demand Process Support
The objective of the on-demand approach is to provide organizations with wide latitude in terms of cost control, scalability and process management simplification.
Such scenarios include:
- A full-service independent coordinator role, managing all aspects of content review and owning all tasks
- Integrated team membership as coordinator and process task owner on specific brands
- Staff augmentation, handling increased volume and specific tasks
- A supplemental coordinator role during extended employee absence or paid time off
The benefits of pharma process management include:
- Shorter time to market
- Decreased enterprise costs
- Focus on organizational goals
- Increased flexibility, efficiency and scalability
- Increased technology platform and infrastructure ROI
Recognized as a leading global provider of promotional and medical review coordinating services, Framework Solutions draws on extensive industry experience in review and approval for more than 500,000 assets for leading companies. To learn more, call today.
