Customized SOP development for:

• Ethics Committee for reviewing Clinical Trials under DCGI
• Ethics Committee for biomedical and health research under ICMR, DHR
• Site SOP for conducting clinical trials
• DNB scientific committee SOP

Navigating the complexities of clinical trials requires a robust framework of SOPs. While generic SOP templates are widely available, they often fail to meet the unique needs of institutions. We specialize in creating tailored SOPs that ensure seamless operations, simplified documentation, and efficient execution of activities, all while maintaining compliance with national and international guidelines.

National guidelines we follow: 

• New Drugs and Clinical Trials Rules, 2019 (India)
• Drugs and Cosmetics Act, 1940 and Rules, 1945 (Schedule Y)  
• National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (ICMR, 2017)
• GCP Guidelines by CDSCO  

International guidelines we follow: 

• ICH-GCP Guidelines E6 (R3)  
• Declaration of Helsinki (WMA, 2013)  
• CIOMS Guidelines (2016)  
• WHO Operational Guidelines for Ethics Committees (2000)  
• FDA Guidance for IRBs (21 CFR Part 56, USA) 

Let Us Help You 

By partnering with us, your institution can ensure that your site and Ethics Committee operates with the highest standards of efficiency, compliance, and ethical integrity. Contact us today to get started on building SOPs that truly work for you.