We specialise in adverse event reporting for prescription drugs, devices and consumer products. All types of cases are processed by our team. We work on client specific projects including large data migration projects. Our team is committed to achieving your pharmacovigilance goals and meeting your deadlines.
We can work with you to design pharmacovigilance services based on your requirements. We will work with your operational procedures and workflows to integrate into your environment flawlessly. Communication and accountability are key factors and we take them both seriously.
ADVERSE EVENT REPORTING:
Our expertise lies in processing all types of adverse event reports:
Our highly skilled team of data entry associate and pharmacists perform case processing for large clinical trial cases. Their talent lies in sifting through large medical record data and extracting relevant information in the case as well as writing accurate medical narratives. The team also coordinates with the investigator and site for additional data requests and follow up information.
We handle all post-marketing case reporting right from spontaneous sources, solicited sources to social media sources.
We perform literature searches according to the client's schedule and do a thorough abstract review. Data entry from the full article and QC are performed by our literature team.
Special Scenario Cases
All type special scenario cases are handled by our team including but not limited to legal cases, pregnancy cases, product quality complaints, etc. We also perform ad hoc reporting projects as requested by client including poison center control reporting and data migration projects.
Our team takes care of end to end case processing services:
- We can also step in at any stage as per client requirements in order to create a model designed to meet your needs.
Each team has members dedicated to literature case processing services:
- In addition we support our clients with monthly literature reports.
We can work with you to design pharmacovigilance services based on your requirements. We will work with your operational procedures and workflows to integrate into your environment flawlessly.
Our team is proficient with Argus and we also have certified MedDRA coders in our team.
Our regulatory experts will work with you throughout the product lifecycle.
We can work on a report in full entirety or a specific section. The following are the reports that we can work on as a comprehensive solution to your aggregate reporting needs.
Periodic benefit/risk evaluation reports (PBRERs)
Periodic safety update reports (PSURs)
Developmental safety update reports (DSURs)
Periodic adverse drug experience reports (PADERs)
Support for risk management plans (RMPs) and risk evaluation and mitigation strategy (REMS)