We are at your service (24X7). We offer;

Clinical Research Monitoring

• Pre-study qualification visits – Feasibility
• Clinical Trial Site Management and Monitoring - Interim Visits, Site Close Outs
• Monitoring Reports and Query Resolutions
• Assessment Visits (co-monitoring visits)
• PK/PD Endpoint Studies & Bioanalytical Monitoring
• Retrospective Monitoring, System Audits & BE CRO Auditing

Formulation & Development

• Complete analytical development and validation as per ICH requirement.
• Drug excipient interaction study
• Formulation development to match the dissolution property of RLD in OGD and multimedia dissolution.
• Technology transfer & Bio-batch manufacturing
• Pilot & Pivotal BE Studies

Professional Medical Writing & Medical transcription Services

•  Discovery Phase, Clinical Research & Post-Marketing
•  Informed consent form and CRF preparation
•  Review and editing of bioavailability & bioequivalence studies report
•  MTS - Regular service, Rush service, Overflow service, Backlog service

PHARMACOVIGILANCE Clinical Safety & Postmarketing Safety

• Adverse Event (AE) and Product Complaint (PC) management.
• Individual case reporting.
• Safety database services.
• Global literature and media monitoring process that includes search strategy and review.
• Safety signal detection and aggregate report management.