Clinical Research Center - Ballerup

CCBR in Ballerup is a modern research unit, that is situated centrally for the participants in Copenhagen and its surroundings. We specialize in the testing of medicines during the time between the development at the pharmaceuticals company, and until the medicine has found its place on the shelf at the pharmacy.

New medicines cannot get approval unless they have been through a comprehensive testing procedure. There has to be a solid amount of documentation showing that the medicines are effective and that they have no damaging side effects. Every drug which is used in the investigations at CCBR has been tested in humans and is without any harmful side effects. The investigations conducted at CCBR are aimed at confirming the effects of the drug on large groups of participants.

The clinic conducts investigations within important areas such as osteoporosis, diabetes, increased cholesterol and cardiovascular diseases. New exciting research projects are continuously coming in and we have a continuing need of recruiting participants for the work done by the clinic.

The participants in our projects are voluntary subjects who receive no fee for their inconvenience. Transport costs are however paid for, and if you show up fasting for blood tests, breakfast will be served. The motivation for participation varies; most people wish to contribute to the development of new drugs which will be of benefit for either their own treatment or the treatment of others.  Many people appreciate their regular visits to the clinic with examinations and contact with the physicians and nurses. During the examinations, the health status of the participants is carefully controlled, and we aim at giving a service of a high professional standard.

The clinic has 32 employees, including physicians, nurses, bioanalysts, radiographers, bone scan technicians and secretaries. We have the most modern equipment for our research. We aim at giving the participants in our studies the best possible treatment and information in order to make their visit to the clinic a good experience and make them feel comfortable participating.

Drug research is regulated by public bodies. In each individual case, the Danish Medicines Agency must give permission to carry out the investigations following an application, and all trials should be approved by an ethical committee. We conduct the studies according to the medical constitution: ”good clinical practice”, GCP, which ensures that all participants receive both written and spoken information, that the safety of the participants is as high as possible and that participation may be terminated at all times.

Our clinic is visited regularly by the regulatory authorities who make sure that the studies are correctly conducted. It relates to CCBR’s internal quality control, the medical companies that pay for the research, the Danish Medicines Agency as well as the European (EMEA) and American (FDA) medicines agencies, respectively.

The participants are recruited through adverts in the newspapers, through letters to target groups and amongst participants in previous studies. We inform the public about the study in the advert and invite potential participants to visit us. During the visit, we inform the potential participants about current research studies, which we can offer our guests to participate in. Then, if they wish to participate in a study, a new consultation appointment is made at another day during their first visit as participants.

It is important to underline that the participants do not receive treatment by us. All treatment required during a period of illness has to take place with their own GP. We are doing research and we collect data for the research project. If any tests show signs of disease, they will be referred to the public health system for further examinations.

Our studies are usually randomized following the natural science research methodology. This is necessary in order to ensure that the results are not biased by random events. This means that half the participants are given active treatment while the other half receives either placebo or another treatment for comparative purposes.

As a participant you are thoroughly informed about the study and about the possible side effects and risks. We inform participants about the legal framework for participation in research studies and about the paticipants’ rights. This includes, for instance, the information that participation is voluntary and that we provide spoken as well as written information which has to be signed by the participant before we are allowed to begin testing. Participants may, at all times, withdraw their consent and be released from the study. Participants may bring an assistant for the information session and subsequent visit.

The information about any research project is always comprehensive and may feel overwhelming. Many pages have to be read, and despite efforts to formulate the material in an easily readable manner, it can be difficult to obtain an overview of all details. We will assist in explaining and understanding the meaning to the extent desired. During the study period, minor changes to the study protocol will always have to be incorporated. All of these changes have to be read and signed as well. So the participants must sign many documents during the study period.

It is important, that you seriously consider if you are able to continue throughout the entire research programme. Continuation throughout the programme is of great importance for the outcome of the study. Too many drop-outs will deteriorate the result of the study. Please ask the doctor about everything, in order to avoid as many unforeseen problems as possible.
When the study is completed, participants receive a letter with information about the outcome of the research study and about the medicine that was used.

A typical study lasts for 1-2 years and involves around 8-10 visits to the clinic. The visits are of a varying nature and may consist of blood sampling, consultation with a doctor and/or nurse, a bone scan and other relevant procedures.

There is no major discomfort associated with participating in the research studies. You must be prepared to use your spare time visiting the clinic, and a certain number of blood samples have to be drawn involving a needle prick in the arm. It is of major importance to the research study that as many participants as possible aim at completing the study. If a participant drops out, we are not allowed to use the study results collected. Then all the efforts have been to no vail.

We are looking forward to welcoming you to our clinic.

Kind regards, Søren Jensen,
Managing Director, Medical Doctor, specialized in thoracic surgery.

 

Address:

CCBR, Ballerup Ballerup Byvej 222, 2750 Ballerup Denmark

Phone: +45 4468 4600

fax: +45 4468 4220

Managing Director of Clinical Research Center: Søren Jensen

 

 

		Søren Jensen, MD
		Managing Director of Clinical Research Center & Physician

 

		Susanne Gydesen, MD
		Physician

  

		Maiken Brix Schou, MD
		Physician

		Line Lindgren, MD
		Physician

 

		Rikke Blom Rossel, MD
		Physician

 

		Annesofie Kragsaa, MD
		Physician

 

		Vicki Thomsen
		Study Coordinator & Head of Local QC

 

 

		Anne Sommermark
		Study Coordinator

  

		Lena Lynggaard
		Study Coordinator

 

		Mette Schledermann Larsen
		Study Coordinator

 

		Luise Mølau
		Study Coordinator

		Mai Christensen
		Study Coordinator

		Ritta Møller
		Study Coordinator

 

		Anita Nielsen
		X-ray Technician

 

 

		Jane Pedersen
		X-ray Technician

 

		Doris Hansen
		DEXA Technician

 

		Inger Dahl
		DEXA Technician

		Lone Høpfner
		DEXA Technician

 

		Gitte D. Henriksen
		DEXA Technician

 

		Anne Holmberg
		Laboratory Technician

 

		Mie Håkan
		Laboratory Technician

 

		Selma Hansen
		Laboratory Technician

		Dorte Nielsen
		Secretary

		Birgitte Krantz
		Secretary

		Inger Gudmundsen
		Secretary

 

		Hanne Rimer
		Secretary

 

		Lene Strid
		Secretary

 

		Karin Bech Laustsen
		Secretary

		Lene Nøhr Hansen
		Secretary

 

		Tanja S. Andersen
		Secretary

		Gitte Brusendal
		Office assistant

 

		Dan Holger Hansen
		Service Technician