At DiagnoSearch, we understand that patient safety is paramount in a clinical trial and takes the highest precedence. Our Safety Team, comprising of skilled medical and safety experts are available 24/7, 365 days a year for vigilant and thorough Safety Monitoring. Enriched with first-hand knowledge of complex global regulatory requirements, DiagnoSearch offers a vast range of Safety Services across all phases of clinical trials which can be specifically tailored to cater to the partner’s needs:

• Dedicated and uninterrupted 24/7, 365 days safety desk

• Development and implementation of a customized Safety Management Plan (SMP)

• Development of study specific SAE / Adverse Event of Special Interest (AESI) / Pregnancy Reporting Forms

• Investigator Team training on Safety Reporting

• Continued support to sites on safety related queries

• Setting up and maintenance of Safety Database (Oracle ARGUS / DiagnoSearch Safety Database)

• Case processing in Safety Database including data entry, primary review and medical review of SAEs

• SAE assessments including causality assessment, evaluation of expectedness of the event to identify SUSARs and determine requirement of expedited reporting

• Development of comprehensive SAE narratives

• Generation and expedited reporting to Regulatory Authorities

• SAE data review to detect events of similar nature for expedited reporting

• Identification of safety signals and safety trends

• Generation of Safety Trackers

• SAE Reconciliation