Practical Cases

ADN has supported successfully a PAI (Pre-Approval Inspection) for a French pharmaceutical laboratory. We were in charge of the IT project management support and of the infrastructure qualification in a very operational way (Centralized directory, back-up system, Local Area Network and Wide Area Network, Data Center, etc).
We were, also, in charge of the review of the processes related to the management of the changes, the configurations, the incidents and the support.

Excel is a widely used tool, however, the risks associated to it are too often under-evaluated, whereas critical data are manipulated and recorded in it.
These risks are not sufficiently considered and, therefore, can compromise the security, the confidentiality and the compliance of the laboratory data. These data are subject to 21 CFR Part 11 regulation (FDA) as the risks associated can be critical.

ADN participated to many projects to secure and ensure the compliance of the Excel files with the regulation. This participation goes from the identification of the needs and the associated risks to the choice of the appropriate solution.
The solution proposed includes the set up of a reliable audit trail and a secure user environment to limit any risk of misuse.

This approach has proved its efficacy and is associated with the validation of the solution and of the Excel files. It has allowed our clients to show a better control of the tool through the risk management and the knowledge of the regulatory and business requirements.

In 2008, a large international pharmaceutical company chose ADN for the set up and the validation of a notification tool.
The application, developed around OC RDC allows the automatic transmission of an e-mail triggered by the entry of data in the eCRF.

The first objective of the project was the e-notification of the serious adverse events entered in the eCRF by the investigator.

Then, the application evolved. New configuration possibilities gave the opportunity to send by e-mail each data, entered in each eCRF, to each selected addressee, in an immediate or postponed way.

The ADN Consultants employed in that project have played a major role in the implementation of this solution. Their expertise in clinical data management and in IT  allowed them to be the interface needed between the future users and the IT team developing the functionalities of the tool.

From the writing of the validation plan, to the deployment of the application, observing the GAMP 5 recommendations, the ADN team participated in all the project phases. Specifically, the testing phase which has been of the highest importance due to the sensitivity of the data handled.
Furthermore, ADN teams used their regulatory expertise, in that project, to obtain a tool compliant with the applicable regulations (21 CFR Part 11, GCP).

ADN has assisted one of the world’s largest pharmaceutical companies in the construction and the validation of a reporting tool. This tool, developed with SAS, allowed the creation of reports on study and patient data, contained in the Oracle Clinical database.

The purpose of the project was to create an application allowing the edition of regulatory reports, to be submitted to health authorities, or work reports facilitating the management of the data contained in the database.

The purpose of the collaboration between ADN and the concerned company was to collect the user requirements related to the clinical reports to be developed (patient and investigator lists, reports on the discrepancies, reports for the validation of the edit checks). The data management knowledge of our Consultants ensured a better management of the users’ needs, and, therefore, a better development of the reports.

ADN has also participated to the writing and the set up of the tests allowing the creation of reports compliant with the user needs and the regulatory requirements (GCP, 21 CFR part 11…).

The knowledge of our Consultants in both clinical data management and the validation of computerised systems give them the double expertise needed to manage the projects related to the clinical data management activities.

ADN works at present on a worldwide E-labelling project.

This last one leans on SPL documents (Structured Product Information) in the United States and on PIM processes and technologies (Product Information Management) in Europe.

The stake is to allow the Product translation and information exchange in 23 languages within 5 days calendar as imposed by competent authorities (FDA, EMEA).
 
Note here, the breakthrough of XML which stands out as the electronic exchange format with agencies. After E2B, CDISC, the SPL and PIM projects also lean on this format.

An ADN consultant  handles the validation of the translation process, the Workflow associated and the product information exchange realized at the European level.
The used tools are SDL Trados and xmLabeling.