Aggregate Reports

Aggregate reports are comprehensive documents used in the healthcare industries to summarize data from various sources, including clinical trials, post-marketing surveillance, and adverse event reports. These reports play a crucial role in evaluating the safety, efficacy, and overall performance of pharmaceutical products, ensuring regulatory compliance, and making informed decisions about public health.

During the clinical development and for the entire life cycle of the drug, the sponsors must submit the safety information to the health authorities within the defined time intervals. This information will help companies and the authority assess the overall risk-benefit profile of the product on a periodic basis. These timelines, frequency, and type of periodic reports vary by country.

Our team is expert in compilation of aggregate reports in accordance with region specific requirements and can publish aggregate reports in eCTD format and submit electronically through portals to health authorities.

Scansio aggregate reporting team will help you compile:

• Periodic Benefit-Risk Evaluation Report (PBRER)
• Periodic Safety Update Report (PSUR)
• Periodic Adverse Drug Experience Report (PADER)
• Addendum to Clinical Overview (ADCO)
• PSUR Addendum Report (AR)
• Development Safety Update Report (DSUR)
• Annual Safety Report (ASR)
   

Our experienced team ensures timely submission of high-quality periodic reports, safety updates, and risk assessments, meeting all regulatory requirements with relevant clinical content.