* Drug Safety and Pharmacovigilance:
- Individual adverse event case processing (data collection, data entry, coding, medical review, and follow-up)
for safety reports received from clinical trials and post-marketing spontaneous and literature sources.
- reporting for pre- and post-approval products
- Aggregate data analysis and signal detection
- Local and global regulatory submissions for individual and preiodic reports.
* Phase IIIb and Phase IV Clinical Trials:
- Studies for new indications or label expansion
- Post-marketing requirements for long-term safety or add-on/comparative effectiveness studies
* Phase II-III clinical trials for FDA, EMEA, and local regulatory
submissions in the therapeutic areas of Cardiovascular
(including devices), Respiratory, Oncology, Gastrointestinal,
Infectious diseases, CNS, Metabolic, and Immunology.
Our dedicated team provides a broad range of therapeutic expertise to serve the needs of pre- and post-approval product development and lifecycle management. Our services range from the full scope of global studies to select stand-alone services.
Faster Development
Through Emerging Markets
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