When planning your clinical trial, it is useful to think about what we review when an application is received. The main objective of our review is to assess the product and its quality, manufacturing and testing from a patient-centric safety perspective. We also assess the scientific design of the study and the conditions for obtaining evaluable data.
A good advice is to come to us for advice in advance. We have two different forms, one where you can ask questions on how to think strategically to best plan your development plan for the marketing authorization application. The second type of advice is more scientifically oriented where the dialogue can take place on the overall development program as well as on an individual clinical trial.
Then, of course, you can visit our website. If you can’t find the answers there, you can ask us questions!
We welcome all kinds of questions, not least from the companies connected to SwedenBio. Much of the innovative development takes place in your companies and in order for us to be able to further develop ourselves and the regulations, we need to be challenged by your questions.
The most common errors are deficiencies or ambiguities in the application or incomplete applications. A cover letter that clearly describes the content of the application helps us, among other things, to ensure that the applicant has included all the intended annexes.
A common “finding” with us is that we see that there are deficiencies in or completely missed a risk/benefit assessment of the participation in the clinical trial, especially if the drug you intend to study is already approved on the market.
Other deficiencies we can see are in the handling of safety reporting, in the choice of dose of the investigational or comparator drug, deficiencies in the statistical analysis or in the documentation on GMP and labeling of the product.
As part of our processing, we have the opportunity to ask the applicant questions, which we do about 30 days after the application has been received, where we point out what we think is missing or what deficiencies we have found. The applicant then has the opportunity to make clarifications and after receiving feedback from the researcher, almost all clinical trials are approved.
Putting time and effort into the preparatory process before submitting the application to the authority is another tip from us. This will be particularly important when the new regulatory framework enters into force, probably at the turn of 2021-2022. A new EU-wide database and portal will be launched to which everyone who wants to apply for a clinical trial needs to submit their application.
The advantage is that if you want to conduct a study in more than one country, you only need to submit an application in the portal, which is then picked up by the countries you want the study to take place in. Another advantage is that you apply to the Ethical Review Authority in the same way, with the same application. The result is a national decision that balances the assessments of both authorities. The launch of the portal also means that communication between applicant companies and the Agency will take place via the computer system.
This way of working will be new for us and for you. We are in the starting blocks with all the preparations and you will certainly hear more about this from us during the year.
When planning your clinical trial, it is useful to think about what we review when an application is received. The main objective of our review is to assess the product and its quality, manufacturing and testing from a patient-centric safety perspective. We also assess the scientific design of the study and the conditions for obtaining evaluable data.
A good advice is to come to us for advice in advance. We have two different forms, one where you can ask questions on how to think strategically to best plan your development plan for the marketing authorization application. The second type of advice is more scientifically oriented where the dialogue can take place on the overall development program as well as on an individual clinical trial.
Then, of course, you can visit our website. If you can’t find the answers there, you can ask us questions!
We welcome all kinds of questions, not least from the companies connected to SwedenBio. Much of the innovative development takes place in your companies and in order for us to be able to further develop ourselves and the regulations, we need to be challenged by your questions.
The most common errors are deficiencies or ambiguities in the application or incomplete applications. A cover letter that clearly describes the content of the application helps us, among other things, to ensure that the applicant has included all the intended annexes.
A common “finding” with us is that we see that there are deficiencies in or completely missed a risk/benefit assessment of the participation in the clinical trial, especially if the drug you intend to study is already approved on the market.
Other deficiencies we can see are in the handling of safety reporting, in the choice of dose of the investigational or comparator drug, deficiencies in the statistical analysis or in the documentation on GMP and labeling of the product.
As part of our processing, we have the opportunity to ask the applicant questions, which we do about 30 days after the application has been received, where we point out what we think is missing or what deficiencies we have found. The applicant then has the opportunity to make clarifications and after receiving feedback from the researcher, almost all clinical trials are approved.
Putting time and effort into the preparatory process before submitting the application to the authority is another tip from us. This will be particularly important when the new regulatory framework enters into force, probably at the turn of 2021-2022. A new EU-wide database and portal will be launched to which everyone who wants to apply for a clinical trial needs to submit their application.
The advantage is that if you want to conduct a study in more than one country, you only need to submit an application in the portal, which is then picked up by the countries you want the study to take place in. Another advantage is that you apply to the Ethical Review Authority in the same way, with the same application. The result is a national decision that balances the assessments of both authorities. The launch of the portal also means that communication between applicant companies and the Agency will be done through the computer system.
This way of working will be new for us and for you. We are in the starting blocks with all the preparations and you will certainly hear more about this from us during the year.
Link to the LV website for advisory services
