Since its establishment in 2008, the Knowledge Centre has developed into an innovative and full-service professional organization with an extensive package of services to support clinical trials. The Knowledge Centre provides coordinated cooperation between the different services. This co-operation of services results in a team working at a high level. “We focus on the goals we want to achieve together with our clients.” Our pharmacists are specialists who are familiar with the latest laws and regulations concerning drug research. This is essential to ensure the quality of our products and services.
Our team has consultants who can offer advice and support in all aspects relating to the design, conduct and completion of a clinical trial. Our professional pharmacists can, thanks to their expertise in different therapeutic areas, provide support in setting up a clinical trial. First your research needs to be approved by the METC to ensure the safety and well-being of patients. Our team provides help with the METC submission by collecting and preparing the necessary documentation concerning the trial medication and offering clinical- pharmacological advice on the design of the research.
Each clinical trial is designed to answer one or more questions. To get answers to these questions, it is important to have an appropriate research design and a well-written protocol. Our pharmacist-team provides help with the drafting of the protocol that is both scientifically sound and practically achievable.
Storage and Distribution
Medication for clinical research at the Academic Medical Center is stored under controlled conditions in the pharmacy in accordance with current procedures. The Knowledge Centre has strictly controlled spaces that are only accessible to authorized pharmacists and pharmacy assistants. The temperature in the storage areas is continuously recorded, and each location is provided with a back-up registration by a temperature logger. Full traceability before, during and after a research is a must. This drug accountability is maintained on standard forms.
- Conditioned storage environment;
- 2-8 ° C medication refrigerators;
- -20C medication freezer;
- -80 ° C medication freezer;
- Opiates cell;
- 24-hour monitoring and alarm system with backup logger.
It is possible to accurately destroy used, opened or expired medicines at the AMC in accordance with the procedures. Storage outside the pharmacy is possible; please consult with one of our pharmacists.
The Knowledge Centre distributes medicines in research for multicenter studies to patients their home or to other centers. This is done according to GDP-guidelines.
Packaging, labeling and Import
The presentation of the packaging and labeling of medications is essential for proper use of the medication. It is also important for the recognition of the medication. Activities such as packaging and labeling are covered in the licensing requirement. The Knowledge Centre has the GMP manufacturing license for packaging and labeling trial medication (see link below). Using this license and our experience we are able to package and label trial medication with high quality, fast delivery and in accordance with the latest laws and regulations.
Our department has GMP manufacturing license for importing trial medication and provides fast and efficient support when importing. Please note that importing drugs outside the EU will take a long time. For more information about these services, please contact one of our pharmacists.
Producing medication or placebo’s for research is externally outsourced by the Knowledge Centre. Through her years of experience and extensive network, the Knowledge Centre has become a specialist in the field of facilitating the production. With its consulting function the Knowledge Centre provides professional advice in the development of trial medication. Think of advice about the right form of administration or on the composition of the medication to match the design of your research.
To use opiates for clinical trials an exemption should be requested. The Knowledge Centre already has the exemption for opiates in the context of scientific research. When an opiate is not on the exemption, it must be requested. Please consider the desired start of the study.
In the Knowledge Centre costs are not only a financial issue, but it should also be linked to correct, effective and efficient implementation of the research.
Within the Knowledge team have staff trained to realistically link the offer to the design of the research. Before the start of the research a quote will be drawn up and the cost of the preparation process will be billed at the beginning. The remaining costs will be charged based on the actual costs. The Knowledge Centre provides specialized knowledge and expertise with high quality at realistic costs.