Does SafetyDrugs have the gateway?

Sure. SafetyDrugs is equipped with the gateway for submitting ICSRs to EMA, FDA and MHRA.
It is also equipped with the Message System to send messages with attachments to authorities and partners.

Is the MedDRA dictionary update included?

Sure. Twice a year, upon the issue of the MedDRA updated version, we proceed to load it in SafetyDrugs free of charge, upon supply by the customer.

How are the data processed?

Upon the contract signature, the client appoints Max Application as data processor.

From that moment on, we will undertake to preserve the data and make them available to the customer at all times.

The data will be stored in Oracle datacentres equipped with the highest security measures in compliance to the GDPR. Daily, weekly and monthly backups are performed and as a further guarantee, the Disaster Recovery service is provided: data are copied to a different Oracle datacentre, so that, in the event of disaster, they are readily accessible to the customer.

The data can be autonomously exported by the customer at any time using specific functions.

Furthermore, to ensure compliance with the GDPR, Max Application, the software house developer of SafetyDrugs, has adopted a DPO. To learn more, we send you to read the article GDPR: why Max Application endowed itself with a DPO

What are the differences between the SaaS or On-premises?

SafetyDrugs is available in two modalities:

• On-premises: with this solution, you purchase the license and you will have the database implemented directly on your company servers by us;
• Software as a Service: it is the cloud solution. in this way, you will rent the database. It will be implemented in an Oracle datacentre equipped with the highest security measures. In addition to the backups, the Disaster Recovery service is also included, this means all data are copied in another Oracle datacentre, to make them immediately accessible in case of unavailability of the service.

You can learn more by visiting the page Quotation

Which tools does SafetyDrugs have to simplify my work processes?

SafetyDrugs is a safety database that allows the collection, management, analysis and submission of ICSR(s). It has also been equipped with various tools that help and simplify your work:

• Work planning: it is an interactive dashboard that allows the control of priorities and deadlines;
• Smart data entry: it is a form made up of necessary minimum fields for the insertion of a case. In this way it will be possible to enter the main details, creating a draft case, to be deepened and completed at a later time;
• Selective import: it is a mask that shows a preview of a case, to confirm, or not, the final import based on inclusion criteria. Excluded cases are always saved into the database and can be listed in a report;
• Search for duplicates: it is a function that allows, during the import phase, to search for possible duplicates using a customizable algorithm;
• Message system: it is a messaging tool that permits you to send emails to your team/partners/Authorities with attachments and to set alerts and reminders for deadlines and quality compliance duties;
• Gateway: it is the portal that allows the automatic submission of cases to EMA, FDA and MHRA.

You can learn more visiting the page: The safety database

How to submit ICSR(s) to the Authorities through the safety database?

It is possible to submit ICSR(s) to the Authorities, in the required format, through two implementations:

• Message System, the tool for sending e-mail messages (included in the safety database standard package);
• Gateway, the portal that allows quick and automatic submission (additional functionality).

What kind of company can use SafetyDrugs?

SafetyDrugs easily adapts to any type of company that carries out pharmacovigilance activities. It is perfect for pharmaceutical companies, CROs and service provider companies.

The database can in fact:

• be made up of one only environment suitable for pharmaceutical companies;
• be divided into as many as needed separate and independent virtual environments, called site(s): each site will have its own specific access with specific credentials. This is the suitable solution for pharmaceutical groups with multiple sender codes, for CROs with different studies or for service providers with several customers.
  The multi-sites solution allows you to manage various situations with a single database.

Furthermore, SafetyDrugs can manage not only ICSR(s) from drugs, but also from medical devices, cosmetics and vaccines by adding the relative modules.

How much does SafetyDrugs cost?

There is no single answer. Being a modular safety database, the price of SafetyDrugs varies according to the needs and requests of the customer. Furthermore, the cost varies according to the solution you choose: purchase or Software as a Service (SaaS).

Indicatively, the costs are divided into:

• initial costs, which include implementation, training and possibly the purchase cost. They may also include legacy data migration and system validation support service.
• service and maintenance fee, which is based on the composition of the chosen package (main module and any additional modules) and, if SaaS mode is chosen, on the rent.

You can get more information by visiting the page How much does SafetyDrugs cost?

You cane request a quote by writing to marketing@safetydrugs.it

Who provides the SafetyDrugs support service?

SafetyDrugs support service is provided directly by our internal staff, a team of technicians, analysts and specialists.
Our customers can request support by opening a ticket through the support portal. In this way, they contact and speak directly with the requested technician and monitor the progress of the ticket.

You can learn more by reading the article How the SafetyDrugs assistance service works.

How long does it take to learn how to use SafetyDrugs?

Thanks to its ease of use, you can learn how to use SafetyDrugs in a few days.
We always recommend a 32-hour training during which both operator and administrator users discover all the functionalities of the safety database to carry out their pharmacovigilance activities and streamline the workload.

You can learn more about the training topics in this article Learn to use the ICH R3 database in four days.

Is any support provided during the system validation process?

As a part of the startup service, we provide the Quick Start Validation Kit, a set of documents compliant with the GAMP5 guidelines, containing the Standard Market Requirements, the Quality and Project Plan, the Design Specifications, the Functional Specifications, the Regulatory Compliance, the Traceability Matrix, the Installation Procedures and the Unit and Integration Tests performed in our standard environment (OQ – Functional Testing).
We provide also the System Configuration Specification (SCS) and consequently the Installation Qualification protocol (IQ).

In addition, we are available to furnish our technical know-how to support the customer during the system validation process.

To learn more, please read this article Simple validation with our help

How does the R2-R3 conversion of data take place?

1. Upgrading of data to R3 format through EMA BFC tool or, in case of Excel sheet, normalization of data and adherence to R3 accepted values;
2. Drafting of a conversion map to define the exact location of E2B and non-E2B data in SafetyDrugs6;
3. Development of migration scripts;
4. Execution of dry run tests to verify the success of the migration process;
5. Execution of quantitative validation;
6. Upon customer’s request, execution of the qualitative validation;
7. Copy of the test environment, with the data contained therein, in the production environment. Provision of the related protocol.

What are the steps of the safety database implementation?

There are five stages in the transition to SafetyDrugs:

1. Initial analysis of the project. The integration path is presented to the customer and all the necessary information to prepare the new process is provided.
2. System implementation. It is the first properly operational phase in which the system is implemented in compliance with the requirements requested by the customer (user requirements).
3. Development of the data migration plan. The structure of the original database, software or Excel sheet, is analyzed and the migration mapping is drafted. Upon the data migration conclusion, the quantitative/qualitative data migration validation is performed.
4. System validation. the validation of a computer system, CSV – Computer system validation, is the whole process that documents the compliance of the safety database with the requirements defined by the EMA and FDA guidelines and by the configuration specification required by the client.
   The Performance Test phase, see us alongside the customer to support him with our expertise in carrying out the tests.
5. Training. It usually takes four days to train both operator and administrator users. At the end the corresponding certifications are provided.
6. Go live. The client can start performing his pharmacovigilance activities in SafetyDrugs. If support is needed, the client can request assistance through our portal with which he can directly speak with the desired technician and monitor the progress of the ticket.

You can learn more by reading the article ICH R3: how long does it take to integrate SafetyDrugs into business processes?

Which pharmacovigilance reports can be extracted with SafetyDrugs?

SafetyDrugs is able to produce the following pharmacovigilance reports:

• line listing
• summary tabulation
• Pregnancy form
• CIOMS
• PSUR
• PBRER
• DSUR
• SMQ
• MedWatch both for drugs and for devices
• MIR
• Audit trail
• Quality check report
• Cover report
• and other dozen of customizable listings for inspective/audit purposes.

All reports are exportable in Excel format.

In addition, the Business Intelligence module is available with which it is possible to perform even more detailed analysis such as comparison between time intervals, quantitative analysis, KPI analysis, parameterizable line listings, signal detection and standard MedDRA queries.

What is the installation time of SafetyDrugs?

The installation time of the safety database is around a few weeks and consists of the following phases: data migration, personnel training and software validation.

You can learn more by reading the article: How long does it take to integrate SafetyDrugs into business processes?

Which adverse events does SafetyDrugs manage?

SafetyDrugs manages adverse events generated by the use of drugs, vaccines, devices and cosmetics.
The ICSRs can be spontaneous, from literature, from clinical trials and from post-marketing surveillance.

Does the safety database help me comply with the GDPR requirements when transmitting outside the EU?

Certainly. SafetyDrugs is equipped with a special module that allows you to set automatic data protection rules, such as the masking of sensitive data, both for XML extraction and report generation.
You can learn more about the topic by visiting the page ICSR transfer outside of EU: how to comply with the GDPR with SafetyDrugs

Who developed SafetyDrugs?

SafetyDrugs is designed, developed, supplied and maintained by Max Application srl, an Italian software house, based in Biella and Turin.
Max Application is made up of a team of analysts, developers, specialists, technicians and systems engineers and it is present on the market with IT solutions for over 20 years.

You can learn more by reading the page About us

Other questions about SafetyDrugs?

Contact us, we are glad to answer any of your questions.