Global and local literature monitoring for adverse event identification across the drug life cycle

Marketing Authorization Holders (MAH) are required to monitor the scientific literature of their products on a periodic basis. Global and local literature search is performed to identify the adverse reactions and for reporting to health authorities.

APCER conducts the literature searches for products under investigational stage (in clinical trial phase), in pre-authorization stages, and post-marketing phase to meet the regulatory requirements of its clients.

Our Literature Search services portfolio includes:

• Global literature screening
• End-to-end literature search and review
• Defining search strategy
• Expertise in handling various literature search databases such as Embase, PubMed, and customer-specified databases
• Medical literature monitoring
• Local literature screening as per local regulations
• Procurement and review of full text articles where applicable
• Translation of literature articles by certified translators