Good Pharmacoepidemiology Practices (GPP)
Good Pharmacoepidemiology Practices (GPP)
- Study Audits: We conduct thorough audits of pharmacoepidemiology studies to assess compliance with protocols, regulatory requirements, and industry best practices. Our experienced auditors evaluate study design, data collection methods, analysis techniques, and overall study conduct to ensure robust and reliable results.
- Protocol Review: Our experts meticulously review study protocols to ensure they are scientifically sound, ethically compliant, and aligned with regulatory guidelines. We assess the study objectives, methodologies, sample size determination, data collection tools, and statistical analysis plans to ensure the validity and integrity of the research.
- Qualification of Personnel & Role and Responsibilities: We assist organizations in identifying and qualifying personnel involved in pharmacoepidemiology studies. Our team evaluates the qualifications, training, and experience of key study personnel to ensure their competence and adherence to relevant regulations and guidelines.