Safety is imperative in clinical trials – new drugs and devices, no matter how innovative, cannot get to market unless proven to be safe for those who will use them. KlinEra Safety Surveillance team provides customized solutions to pharmaceutical, biotechnology and medical device companies to effectively track and manage their products’ benefits and risks throughout the product lifecycle. We can provide our clients with end-to-end safety services from early phase through approval and post-marketing
SAE Case Processing & Reporting:
Collection of SAE data and provision of 24/7 adverse event support. Submission of IND safety reports to regulators & investigators. Creation of subject safety event narratives. Medical coding (both MedDRA and WHODD).
Adverse events assessments and SAE case review and support. Monitoring and review of safety trends and events, labs, demographics, medical history and coding. Protocol guidance and general medical support for investigators.
Phase I-IV protocol development and regulatory support. Investigator’s Brochure, labeling and ICF development. CSR writing and compilation of all appendices; submission to competent authorities.
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KlinEra Global Services
KlinEra provides innovative, customized clinical trial and research services.
311-313 Piercy Road San Jose,
P : (408) 365-3231
F : (408) 365-3232
801, Neelkanth Corporate Park,
Vidhyavihar West, Mumbai 400086.
P : +91 22 2509 1470
F : +91 22 25004588