Data Publication Service

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Data Publishing Service To support 
EMA Regulatory Reporting Requirements

Information text on the opening of the image in lightbox (magnifying glass)As of 21 July 2014, it has become mandatory for
sponsors 
to post clinical trial results in the
European Clinical trials Database (EudraCT),
managed by the European Medicines Agency (EMA).


Under this framework, summary results of clinical trials
will become available to the to the public as sponsors
start to comply with their legal obligations. A subset of
the data included in EudraCT is made available to the
public in the European Union Clinical Trials Register.
The content and level of detail of these summary results is
set out in the European Commission guideline and
in its technical guidance.

 

 


 

Process Definition

BDLS has worked with several pharmaceutical
companies to develop a wide range of processes
to ensure compliance to the regulations.

 

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XML Submission

Data can be submitted by
entering directly into the system
or by XML BDLS has developed
expertise in structure that is
required and has created a
validated suite of macros to assist
with the process understanding
the XML structure that is required.

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BDLS can provide you with a solution!

 

BDLS has developed an industry leading set of solutions to assist clients with the posting of clinical trial summary results into the EudraCT system. We can provide help clearing your backlog... We can assist you in developing a process for dealing with ongoing studies… Or, we can provide general consultancy advice around the process, the requirements and the technical aspects of the guidance.

 

Different companies will require varying levels of support of advice.


 


 

 Speak to one of our data experts about how we can assist with 

backlog reporting, process development, or consultancy

Download the Data Pub Document

  • Data Publication Service Offering (EMA)

    As of 21 July 2014, it has become mandatory for sponsors to post clinical trial results in the European Clinical trials Database (EudraCT), managed by...

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Data Publication Service Offering (EMA)

As of 21 July 2014, it has become mandatory for sponsors to post clinical trial results in the European Clinical trials Database (EudraCT), managed by...

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Contact us

life.sciences@businessdecision.com

Call +32 2 774 11 00

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