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Clinical trials with medicine support

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The department of Clinical  Pharmacy and Pharmacology (CPP) plays an important role in clinical trials with medicine at the UMCG. This page provides information about the expertise of CPP and services in this research.

Practical implementation

The department of Clinical Pharmacy and Pharmacology dispenses drugs to the hospital’s patients but can also supply study drugs for clinical trials. This requires effective coordination between the investigator, the department of Clinical Pharmacy and Pharmacology& and the pharmaceutical industry.

Study drugs

A vast range of drugs are used in clinical trials. These could be new experimental drugs or available drug  products to be registered for a new indication. The support provided by CPP varies depending on the nature of the product. This is determined per individual study in consultation with the investigators.
The department of Clinical  Pharmacy and Pharmacology  is GMP-certified to manufacture study drugs if required.

Manufacturing study drugs and randomization

The department of Clinical  Pharmacy and Pharmacology  is GMP-certified to manufacture study drugs and placebo medication: radiopharmaceuticals, sterile preparations (ampoules, vials for parenteral administration) and non-sterile preparations (capsules, tablets, dermatics and beverages). In addition, CPP can also randomize medication.

If an investigator wishes to develop a investigational medicinal product  for clinical trials he or she should contact the department of Clinical  Pharmacy and Pharmacology as early as possible in the process. CPP will register the particulars of the investigational medicinal product that is needed and will estimate the costs to be made for development. A progress meeting will be held with the investigators during the development phase.

Clinical pharmacokinetic research

The concentration of a drug in blood, urine or another body fluid (such as sweat, saliva and cerebrospinal fluid) can be determined in both humans and laboratory animals. The  laboratory of the department of Clinical  Pharmacy and Pharmacology  has a large number of operational analysis methods available to this end. The laboratory of CPP can also develop specific analysis methods for clinical drug research at the investigator’s request. Call the laboratory pharmacist on 050 3614080 to discuss the requirements of your project.

Quality Assurance

The department of Clinical  Pharmacy and Pharmacology has an integrated quality management system with ISO 9001 certification. This includes a certified patient safety management system in accordance with NTA 8009.

CPP is GMP-z certified (Good Manufacturing Practice for hospitals) and has at its disposal a manufacturing license for import and manufacturing investigational medicinal products also including radiopharmaceuticals for clinical trials with medicine. The department of Clinical Pharmacy and Pharmacology adheres to GCP (Good Clinical Practice) guidelines. The laboratory of CPP is ISO15189 certified.

Fees

The department of Clinical  Pharmacy and Pharmacology  charges fees for work to be done for clinical trials with medicine. CPP will prepare a cost estimate prior to the work on the basis of rates per activity. The actual fee will be calculated on actual costs. The quote and working agreements made with CPP will be included in the contract that is drawn up between the investigator or industry and the UMCG.

The costs associated with developing investigational medicine or development of a method of  analysis for pharmacokinetic research can vary. Should the investigator  require the department of Clinical  Pharmacy and Pharmacology  to develop an investigational medicine or method of analysis , then an appropriate quote will be made in advance.

Clinical Pharmacy and Pharmacology: units and their activities

Various hospital pharmacy units participate in the execution of clinical trials with medicine.

Production and Product Development unit

  • Development, production, packaging, labelling and preparation for use of investigational medicinal products.
     

 Clinical trials unit (OKO)

  • Provides advice to investigators.
  • Coordination of the activities of the department of Clinical  Pharmacy and Pharmacology  for clinical trials with medicine.
  • Logistical management and storage of investigational medicinal products.

Medication management and distribution unit

  • Dispenses study drugs.

Laboratory

  • Analysis of investigational medicinal products and pharmacokinetic r​esearch.