Start up team / Submissions

 

Many of our clients find it is very easy to be lost when trying to understand all the necessary requirements to start a multicenter clinical trial in Europe. Furthermore, some countries, like Spain or Germany, have different regional legislations, which can bring a few surprises to the process and have a negative effect on the timelines. Some of our clients are not aware of mandatory country specific submissions like CNOM in France, the Data Commission in Belgium or Denmark or the Board of Directors approval in Netherlands and Spain. To make things even more difficult, language can be a big obstacle as it is not always possible to find the information translated into English, especially in Southern or Eastern Europe.

As a result of all these obstacles and legislation complexities, D-TARGET decided in 2007 to create a specialized team dedicated to obtaining the necessary approvals to start all medical device studies: the START-UP team.

In the last 2 years the start up team has successfully performed over 200 submissions for approval to Ethics Committees and 72 submissions for approval to competent authorities. These studies were mostly carried out in Western and Eastern Europe but still included a selection of submissions to somewhat unusual countries such as Monaco, Luxembourg or Finland. Thanks to the support for Premier Research’s local CRA network across Europe, the Start-Up team is able to respond to any language requirements arising from the submission process. 

Having a specialized team dedicated to the approval process has allowed us to improve its quality and timelines. It also allows us to provide an experienced support to our clients in this subject, particularly interesting when deciding on the strategy to follow for projects with short timelines.

The Service: Planning, Keeping track

The service provided by the start up team comprises the whole process from when the study documents are completed until all the final approvals are obtained to be able to start the study sites.

As Ethics Committee meeting frequencies vary, and can be full even before the announced deadline, timelines are an essential part of our focus. We pay special attention to meet these deadlines, by planning ahead all submissions in our calendar and by keeping an excellent relationship with the Ethics Committees.

For the whole length of the approval process, the status of each individual submission is meticulously introduced into a general tracking log on an ongoing basis, making it possible at any time to check on the progress and prepare for the next actions. This tracking is printed for each study and serves as a report providing the history of the approval process and a full overview of the key study documents: EC approval dates and approved Patient information as well as important remarks from Ethics Committees.

Information database

D-TARGET has an internal database of over 180 Ethics Committees containing all the useful information we have come across whilst preparing our past submissions. Besides the indispensible contact details we collect other less accessible information. Here is a list:

• Address and contact details
• EC website
• Meeting frequency (dates)
• EC Fees
• hospitals covered by this EC
• List of required documents for submission
• Specific guidance for each EC
• Specific forms to be used
• Preferences in packages (nb copies, staples CD)
• Questions asked for previous studies
• Paragraphs for patient information suggested by EC
• Anything useful for the next submission
 

The database also contains similar information for 30 Competent Authorities and country by country legislation applicable to medical devices. This database was started in 2007 and grows year after year as the company’s experience is captured and filed. The main objective is to keep all the information which will help save time or prepare a better dossier for the next Ethics Committee/ Competent Authority submission, which in our case, is never too far away.