CRO SERVICES
Drug Development Planning
SRA helps biotechnology and pharmaceutical companies get their products to market quickly and cost-effectively. As a global contract research organization (CRO), we understand the international regulatory environment and can lead and manage full clinical development programs.
Our role can begin in the pre-clinical stage or at any point in the drug development continuum. We oversee preparation and submission of the Investigational New Drug/Clinical Trial Application (IND/CTA) plan and manage the clinical trial program and progress the compound through to New Drug Application/Marketing Authorization Application (NDA/MAA) submission and approval. With this turn-key approach, clients are free to spend their limited internal resources on other projects.
Benefits
- Speeds time to market for new drugs
- Provides single resources for all phases of development
- Facilitates approvals from global health authorities
- Centralizes project management to efficiently steer program from inception through clinical development
- Supplements staff expertise and resources
Services