1) What kind of help will I receive from Clinical Trials Office Denmark in connection with the site identification service?
Within four working days, Clinical Trials Office Denmark will provide you with contact information for potential sites/investigators throughout Denmark who can conduct the trial.
2) Who should I, as a representative of a pharmaceutical company/CRO, contact for assistance to identify relevant sites?
You should send a brief description of your requirements and needs for sites to Clinical Trials Office Denmark. The description can be emailed to us via:
Clinical Trials Office Denmark will answer your inquiry within four days.
Please be aware that disease-specific networks have been established within certain specific therapy areas in Denmark. These include respiratory medicine and breast cancer. Enquiries for these therapy areas should be addressed directly to these disease specific networks.
3) What type of information does Clinical Trials Office Denmark need to answer your request concerning a clinical trial?
In order to provide a targeted service we would be grateful if you could provide as much information as possible with the enquiry. This includes:
- Protocol title
- Trial Phase (I, II, III, IV)
- Patient population
- Drug/medical device concerned
- Request for specific expertise
- Blinded synopsis
- Have any potential sites/investigators already been contacted, if so, which?
4) When will I receive a response to my enquiry?
Within four working days you will receive a list of relevant sites/investigators. In the event of specific and rare diseases the process may take more than four days. Shortly after contacting us you will receive an e-mail confirming that Clinical Trials Office Denmark is processing your email
5) What if I have a site-feasibility questionnaire that must be completed?
Clinical Trials Office Denmark expects companies/CRO’s to arrange for the distribution and collection of results from questionnaires from relevant researchers themselves.
6) Sometimes as a CRO I only have a few days in which to respond to a sponsor with information as to whether a specific trial can be conducted in Denmark. What should I do in this scenario?
If you make us aware of the tight deadline when enquiring, we will endeavour to respond as quickly as possible.
7) After making an enquiry to Clinical Trials Office Denmark I have received an e-mail containing contact information for potential and relevant investigators. But upon contacting the persons listed I found that they had no interest in participating in the trial.
There may be local circumstances and challenges which mean that an investigator has to decline a request to conduct a clinical trial. Clinical Trials Office Denmark does not have the authority to overrule such decisions.
8) Some months after the initial correspondence with, I received some questions from Clinical Trials Office Denmark. Why is that?
After contacting us you will receive an evaluation questionnaire via e-mail. We would be grateful if you could respond to this e-mail with as much detail as possible. This will substantiate our work to identify challenges and minimise the barriers for clinical trials and medical device trials in Denmark. The questions will include areas such as:
•Is Denmark participating in the trial concerned?
•If no, why not?
•Which sites have been contacted?
•Which sites are participating?
•If your company excluded some sites, what was the reason?
•Have you experienced any specific challenges in connection with this trial?