Pharma Specialists

Clinical Trials

FDA Audit Checklist for Clinical Trials

FDA inspections for clinical trials are generally conducted when…

December 05, 2023

Clinical Trials

Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments

This document provides technical specifications for the submissi…

November 11, 2023

Clinical Trials

Phases of Clinical Research

Each phase of clinical research has its own unique goals and cha…

October 21, 2023

Clinical Trials

ICH E6 (R3) Guideline on Good Clinical Practice (GCP)

Good Clinical Practice (GCP) is an international, ethical, scien…

June 21, 2023

Clinical Trials

GCP Guideline on Computerized Systems and Data Integrity

Following the draft guideline published in June 2021 the final E…

June 18, 2023

Clinical Trials

Clinical Drug Interaction Studies with Combined Oral Contraceptives

This guidance is intended to help sponsors of investigational ne…

June 15, 2023

Clinical Trials

Why Blinding in Clinical Trials is Important?

Blinding (or Masking) in clinical trials means that either parti…

March 03, 2023

Clinical Trials

Clinical Trial Feasibility Study

Clinical trial feasibility study is a process of evaluating the …

December 28, 2022

Clinical Trials

General Considerations for Clinical Studies | ICH E8

The General considerations for clinical studies' is intended…

December 14, 2022

Clinical Trials

Multiple Endpoints in Clinical Trials | Guidance for Industry

Efficacy endpoints are measures designed to reflect the intended…

October 25, 2022

Clinical Trials

Ethical Considerations for Clinical Investigations of Medical Products Involving Children

FDA recently published a draft guidance on Ethical Consideration…

October 18, 2022

Bioequivalence Study

Difference between Protocol Violation and Deviation

Protocol deviation is an accidental or un-accidental changes or …

December 15, 2021