Our solution for automated sample tracking, IQVIA Digital Sample Management, is so innovative that it generates many questions from interested clients. Here, Wim Moortgat, Project Manager, and Philip Dheulin, Senior Consultant, both of IQVIA Belgium, answer some of the most frequently asked questions about the new service...
- Has the Belgian Federal Drug Agency (FAGG/AFMPS) approved IQVIA’s new digital solution? In other words, does it meet the agency’s requirements?
We met with representatives of the FAGG/AFMPS in March of 2019. The agency reviewed the tool and confirmed that the process incorporated in the solution is compliant with Belgian regulations. Indeed, relying on the application reduces the risk of non-compliance and error.
- Is the digital signature legal and compliant with Belgian regulations?
The FAGG/AFMPS has certified that the prescriber’s digital signature within our solution (E-ID Card and pin code) serves as proof of sample delivery and is the legal equivalent of a handwritten signature. So, we can conclude that it is safe for companies to use.
- What happens if we cannot collect the signature digitally?
There are occasional situations (the PIN code is unknown, bad internet connection, …) in which it is not possible to collect a digital signature from a prescriber. It is for these situations that the IQVIA solution includes a manual, fallback solution: paper-based proof of delivery. The signed paper is then scanned into the system and given a unique number. Thus, it is recorded into the database and easily retrievable.
- Is it possible to enter a sample quota into the system?
Yes. The system will track sample distribution against pre-set quotas. These can be defined at product level and for different periods (Year-to-Date or Custom set period). If the quota will be exceeded with a rep’s request, the system generates a warning for the rep and depending on the chosen setting it will also block the transaction. The system will prevent a request from being sent to a third-party distributor.
- Is the data registered into the application in real time?
Yes. When reps prepare their transactions in the system, they have visibility to their transaction history and will be given an immediate response should their current request go over the established quota.
- Can the application automatically recognize two-dimensional Global Trade Item Number (GTIN) codes on sample boxes?
Since February 2019, all medicines must bear a GTIN code to support traceability of the product and prevent counterfeiting. The IQVIA solution does, in fact, read the GTIN code and links it to the product sample in the database.
- How do reps record transactions into the system?
This can be done in one of three ways. The first is by scanning the sample’s GTIM code, as explained above. The second is by choosing the product identity from a predefined “picklist” and the third is by scanning the barcode on a sticker affixed to the sample box. (IQVIA can produce these stickers and send them to the logistics center.)
- Can we integrate sample data from the digital sample system into our CRM system?
Yes. IQVIA can configure the dataset of sample data so that it can be exported to be integrated with any specific client system.
- We have a logistics partner who distributes our samples. Can the application work with different logistic partners?
Certainly. The system was built with this in mind. Sample requests are sent automatically from the application to the logistics partner of choice on a regular basis. The delivery status is then updated in the application. So, information flows both to and from the logistics partner, automatically.
- How can the application support us in complying with the annual reporting requirement of the Belgian Medicines Agency (FAGG)?
The sample management application automatically generates two types of reports of all samples distributed. The first is a count of the number sample transactions, the second is a list of the samples with full details. The first list satisfies the requirements of FAVG to report by March 1st the samples distributed in the prior year.
To conclude IQVIA’S Digital Sample Management gives all involved visibility to the sample ordering and distribution process, making it easy to ensure that samples are delivered in a timely and compliant fashion. Left with more questions? Read our factsheet here or contact your Key Account Manager.