How to Procure

How to Procure
a Safety Database from BaseCon

1

Sales

The buying process often  requires much contemplation, comparison and requirement assessment. BaseCon will assist you and your company for the duration of this process, with documentation, demonstrations and quotations amongst others. We can offer product demonstrations on-site or via the web through a web meeting tool, this is especially convenient for quick questions and answers.

2

Contract Negotiation

We produce a customer contract, which we will use as a starting point. The contract contains standard text needed to form a business partnership. It also contains a Service Level Agreement. The sales representative from BaseCon will then go through the contract with the customer and then discuss if anything should be changed or added to the contract. The customer will have the possibility of having their attorneys review the contract. When the negotiations are completed, the contract is signed and the agreement comes into force.

3

Database Setup

Once the contract has been signed, we begin working with the database setup. The database is hosted nad web-based, which means that it requires very little setup. The customer is asked to fill out a Database Setup Form, when this is done the database will normally be ready within one week. The Setup Form contains standard database information like system owner details, and it contains parameters for causality and labeling assessment. The sales representative will work together with the customer to determine the appropriate parameters for your organization. As a standard service, the customer owns two separate databases, one for daily operations and one for testing/training. BaseCon has extensive knowledge and experience in data migration and will assist you in this process should you require it.

4

User Training

The main training session takes place when the database setup and validation has been completed. This is usually done at your premises and in a group. For data entry, medical review and search functionality only one day is required. For the administrative and more advanced levels, two days are normally required. BaseCon is always available via telephone and with a few clicks via our online training tool.

5

Testing & Validation

You will use the requirements from your internal Quality System to test and validate the database. In our experience, this phase takes between two days and four weeks. If you choose to test the electronic gateway BaseCon provides expertise and extensive assistance in testing with the EMA EudraVigilance gateway and the FDA-ESG gateway. You will have to submit 10 test-cases containing your own data.

6

In Operation

During daily operations the two databases will be available 24/7 from anywhere in the world. The daily operational database will be used for data entry, imports, searches and reporting. The test database will normally be used for training and testing i.e. upgrades.

7

Quality Control

BaseCon has a Quality System in place to assure compliance with applicable US-FDA and EMA regulations and guidelines for Computerized Systems and Application Software designed, developed, and tested for use by our clients in the pharmaceutical, biotechnology, and medical device industries. BaseCon is naturally available for audits at any time during the contract period.

8

Enhancements & Corrections

When BaseCon develops enhancements or corrections these will be made available to all customers. The changes will be applied with patches or as a new version. Patches are first applied to the test database and not before the customer accepts the patch; it is the applied to the daily operational database as well.

9

End of Contract

If our contract comes to an end, BaseCon will provide full assistance in migration or data transfer to any other database. You will receive, in a manner agreed upon in the contract, a database extract containing all information in your database. Once you have validated this extract, BaseCon will securely delete all records of your company on our servers.

Back to the top
  • Sales
  • Contract
    Negotiation
  • Datebase Setup
  • User Training
  • Testing and
    Validation
  • Quality
    Control
    In Operation
    Enhancements and
    Corrections
  • End of
    Contract