Best Practices and Clinical Trial Logistics

by Dr. Antoine Balland, Eurofins Pharma Quality Control, AntoineBalland@eurofins.com

Clinical research today is defined through large legislative and regulatory guidelines, and its success depends on recruitment of patients, experimental drug manufacturing and distribution to the clinical investigation centres. The main texts are: ICH E6 Guidelines for Good Clinical Practices (GCP): Defines the principles and guidelines applicable to all clinical studies of drugs, including pharmacokinetics and phase I, II, III, IV studies. The ICH E6 harmonises the various existing regulations (EU-USA-JAPAN).

European Directive 2001/20/EC: This guideline defines what a clinical study is and focuses on the protection of patients involved in clinical research. It also defines the exchanges of information between EU Member States through the database EUDRA CT (European database).

European Directive 2005/28/EC: This Directive completes 2001/20/EC but is more convenient. It redefines Good Clinical Practices for the design of studies and data monitoring. European Directive 2003/94/EC: This establishes that experimental drugs should be produced according to Good Manufacturing Practices (GMP). All articles in this Directive are explained in GMP Annex 13.

GMP Annex 13: Procedures used in the manufacturing process must be adapted to the development of the product. The manufacturing of a new drug remains an experimental process. Complex data and manufacturing processes are still in the validation phase. Packaging (primary and secondary) is a critical step. The packaging must be customised, according to the protocol, the patient and test group.

Good Distribution Practices (GDP): Describes the process for reception, storage, shipping, tracking, returns management, destruction and batch recall of clinical drugs. Since 2000, Eurofins Pharma Quality Control has been offering complete solutions to combine global and legal compliance (ICH, GCP, GMP, and GDP) and effectiveness of a clinical study, including:

• Therapeutic unit management: Import, Packaging, Labelling, Control, Batch Release, Stability Studies, Supply of Comparator, Randomisation, Returns Management, Reconciliation, Destruction
• Multi temperature storage facilities, large volume (-80°C, -20°C, +5°C and +20°C)
• Distribution, refrigerated transport, validated insulated boxes
• Manufacturing of biological sampling kits

For more information, visit www.eurofins.com/pharma