Clinical Studies

Clinical Studies are research investigations conducted to evaluate the safety, efficacy, and quality of medical products, treatments, or interventions in humans. They follow structured protocols across different phases—ranging from early safety assessments to large-scale trials—ensuring scientific rigor, regulatory compliance, and the generation of reliable data to support medical advancements.

Real-World Observational Studies (RWOS)

Real-World Observational Studies (RWOS) gather data on the safety, effectiveness, and usage patterns of medical products in real-life settings. Conducted outside the controlled environment of traditional clinical trials, RWOS provide valuable insights into patient outcomes, treatment adherence, and healthcare practices—supporting evidence-based decision-making and regulatory requirements.

Late Phase Studies (LPS)

Late Phase Studies (LPS) are conducted after a product has received market approval to collect additional evidence on long-term safety, effectiveness, and real-world usage. These studies help refine clinical practice, meet regulatory requirements, and ensure continued patient safety.

Post-Marketing Surveillance (PMS): Continuous monitoring of approved products to detect rare or long-term adverse effects and maintain a favorable benefit–risk balance.

We provide the following solutions under the domain of clinical Studies

1. Clinical Operations
2. Data Management
3. Biostatistics
4. EDC Support
5. Site Management( SMO)
6. Safety Monitoring
7. Scientific & Regulatory Writing

+91 22 4226 9999
info@insigniacom.com
Mon - Fri 10.00 - 18.30
Weekend Closed
405 & 406, Mittal Commercia,
Hasan Pada Road, Marol, Andheri (East), Mumbai - 400059, India