Literature Reviews
Monitoring Drug Safety through Global and Local Literature Searches
Marketing Authorization Holders (MAHs) have a critical responsibility to continuously monitor their products' safety throughout the drug lifecycle. This involves actively searching and identifying potential adverse events (AEs) through various methods, including global and local literature monitoring.
Think-i's Expertise in Literature Searches:
Think-i offers comprehensive literature search services to support MAHs in fulfilling their regulatory obligations. We conduct searches for products at different stages:
- Investigational Stage (Clinical Trials) : Early identification of potential AEs is crucial for informed decision-making regarding safety and efficacy.
- Pre-authorization Stages : Through literature review contributes to a robust dossier submission for regulatory approval.
- Post-marketing Phase : Continuous monitoring is essential to detect rare or long-term AEs and ensure patient safety.
Our Services:
- Literature Screening: We scan a broad spectrum of international databases to capture relevant information.
- End-to-End Search and Review: Our team manages the entire process, from defining search strategies to reviewing results.
- Search Strategy Development: We tailor search strategies using relevant keywords, MeSH terms, and Boolean operators to ensure targeted retrieval.
- Database Expertise: Our team is proficient in using diverse databases like Embase, PubMed, MEDLINE, and client-specific sources.
- Medical Literature Monitoring: We regularly monitor medical literature for updates on safety concerns and emerging trends.
- Local Literature Screening: We comply with specific regulations in different regions by conducting local literature searches.
- Full-Text Procurement and Review: We acquire and review full-text articles to confirm the details of reported AEs.
- Translation Services: When necessary, we utilize certified translators to handle articles in foreign languages.
Benefits of Think-i's Services:
- Comprehensive AEs Identification: Our extensive search process minimizes the risk of missing potential safety signals.
- Regulatory Compliance: We ensure adherence to relevant regulations around drug safety monitoring.
- Time Efficiency: Our expertise allows MAHs to focus on core business activities while we handle the literature search process effectively.
- Enhanced Patient Safety: Proactive identification of AEs contributes to informed safety decisions and ultimately, protects patient well-being.
Think-i's comprehensive literature search services offer a valuable solution for MAHs to meet their regulatory requirements and proactively manage the safety of their products. By leveraging our expertise, MAHs can gain valuable insights into potential AEs and contribute to a safer drug development and usage landscape.
