Comprehensive in compliance with Good Clinical Practices for pharmaceutical activity in clinical trials

Authors

Keywords:

Clinical trials, Pharmacy, Good practices, publication quality, Audits

Abstract

Introduction: Pharmaceutical activity during the clinical development of biotechnological drugs requires compliance with the highest standards of good clinical practice.

Objective: To design and implement a training program to contribute to compliance with good clinical practice in pharmacies at clinical sites.

Methods: Between 2017 and 2025, a training program was implemented for pharmacy staff involved in clinical trials with products from the Center for Genetic Engineering and Biotechnology. This was a longitudinal, multicenter, quasi-experimental educational intervention study. The program included the development of standardized procedures; national symposia; and study initiation workshops for site pharmacists. The effectiveness of the training was evaluated through internal follow-up audits and the results of regulatory inspections.

Results: There was improvement in compliance with good clinical practices, with the resolution of identified deficiencies. This was supported by four national symposia, which brought together more than 100 professionals from 66 clinical sites in 14 provinces. Validation of the program's effectiveness was obtained through internal follow-up audits and corroborated externally during the clinical development of the Abdala® COVID-19 vaccine.

Conclusions: The training program developed for pharmaceutical activity in clinical trials is successful. It guarantees the rigor and credibility of the handling of biopharmaceutical products, with proper adherence to good practices.

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Published

2026-05-31

How to Cite

1.
Rodríguez Reinoso JL, Hernández Bernal F, Nodarse Cuní H, Campa Legra I, González Delgado CA, Aroche Estalella K, et al. Comprehensive in compliance with Good Clinical Practices for pharmaceutical activity in clinical trials. Invest Medicoquir [Internet]. 2026 May 31 [cited 2026 Jun. 6];18(1):e1041. Available from: https://revcimeq.sld.cu/index.php/imq/article/view/1041

Issue

Vol. 18 No. 1 (2026): in progress

Section

Research article

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Copyright (c) 2026 José Luis Rodríguez Reinoso, Francisco Hernández Bernal, Hugo Nodarse Cuní, Iván Campa Legra, Carlos A. González Delgado, Katia Aroche Estalella, Camilo Serrallonga Trujillo, Ketty Cruz Chirino, Elizeth García Iglesias, Dayana Rojas Socorro, Verena Lucila Muzio González

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