Trusted Resource for Clinical Trials, Protocols & Progress
The purpose of this SOP is to outline the standardized process for preparing, reviewing, submitting, and tracking clinical trial regulatory submissions including Investigational New Drug (IND) applications, Clinical Trial Applications (CTA), and Clinical Trial Notifications (CTN). This ensures compliance with ICH-GCP, GMP, WHO, and local regulatory requirements (e.g., US FDA, EMA, CDSCO, MHRA, TGA).
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The purpose of this SOP is to describe the process for preparing, reviewing, submitting, and tracking clinical trial protocol amendments and associated regulatory notifications. This ensures compliance with ICH GCP, GMP, WHO guidelines, and national regulatory authority requirements (FDA, EMA, MHRA, CDSCO, TGA).
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The purpose of this SOP is to define the procedures for compiling, reviewing, and submitting safety updates in clinical trials, including Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR), and Annual Safety Reports. These updates ensure ongoing assessment of investigational product safety, regulatory compliance, and protection of trial participants, as per ICH E2F, GCP, and applicable local regulations.
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The purpose of this SOP is to establish a standardized process for the preparation, submission, and follow-up of Expanded Access and Compassionate Use applications for investigational products. These submissions ensure that patients with serious or life-threatening conditions, who lack therapeutic alternatives, can access investigational drugs outside traditional clinical trials, in compliance with ICH-GCP, WHO, FDA, EMA, CDSCO, and other global regulatory authority requirements.
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The purpose of this SOP is to define standardized procedures for preparing, reviewing, submitting, and tracking clinical trial submissions for medical devices, including Investigational Device Exemptions (IDE). It ensures compliance with FDA 21 CFR Part 812, EMA Medical Device Regulation (MDR 2017/745), CDSCO Medical Device Rules (2017), WHO, and ICH GCP guidelines.
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The purpose of this SOP is to provide standardized instructions for preparing, submitting, and tracking initial applications to Ethics Committees (EC) or Institutional Review Boards (IRB) for clinical trials. This ensures compliance with ICH-GCP, WHO, FDA, EMA, and CDSCO requirements while safeguarding the rights, safety, and well-being of trial participants.
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The purpose of this SOP is to describe the process for conducting Ethics Committee (EC) and Institutional Review Board (IRB) continuing reviews and renewals of clinical trials. This ensures ongoing ethical oversight, participant protection, and compliance with ICH-GCP, WHO, FDA, EMA, and CDSCO regulatory requirements.
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The purpose of this SOP is to provide guidance on the preparation, submission, and follow-up of amendments and notifications to Ethics Committees (EC) and Institutional Review Boards (IRB). It ensures compliance with international (ICH GCP, WHO) and national (FDA, EMA, CDSCO) requirements for safeguarding trial participants and maintaining ethical oversight.
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The purpose of this SOP is to define the procedures for ensuring that Ethics Committee (EC)/Institutional Review Board (IRB) meetings meet quorum requirements and for managing conflicts of interest (COI) among members. This guarantees unbiased decision-making, participant safety, and compliance with international and local regulatory requirements.
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The purpose of this SOP is to establish standardized procedures for documenting and managing all communications with Ethics Committees (EC) and Institutional Review Boards (IRB), including meeting minutes, decisions, approval letters, and correspondence. This ensures transparency, accountability, and compliance with ICH GCP, WHO, FDA, EMA, and CDSCO requirements.
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