Clinigma® is now ISO 9001 certified

At Clinigma®, we are proud to announce that we have achieved an ISO 9001 certification in designing, conducting, analysing and reporting patient interviews in relation to clinical trials. The ISO certification was obtained after a successful ISO certification assessment performed by DNV-GL – a global quality assurance and risk management certification body.

Achieving an ISO 9001 certification demonstrates the strong commitment of Clinigma® to provide high-quality services to our clients, and it is an assurance that we have effective and clearly defined procedures in place to ensure consistency in our way of work.

In our efforts to ensure compliance with the ISO 9001:2015 standard, we have escalated our continuous work to strengthen and structure our standard operating procedures (SOPs), and we have performed an extensive risk assessment to establish the right measures to effectively eliminate or control any risks.

The ISO 9001 certification is an important milestone for Clinigma®.

ISO 9001 certification
What does it mean and why is it important?

The ISO 9001:2015 is an internationally recognized standard that specifies a number of requirements for a Quality Management Systems (QMS). It defines a number of guiding principles for a company to ensure the effectiveness of its procedures to help improve the overall performance and provide a sound basis for sustainable development activities.

Successfully completing an ISO certification assessment performed by DNV-GL, Clinigma® has demonstrated full compliance with the ISO 9001:2015 standard. This proves our commitment to deliver services consistently at the highest level of quality, which is especially important when working with the collection and handling of interview data from clinical trials.

To exemplify the importance, here are a few examples:

  • Following effective and clearly defined procedures for the patient interview process, Clinigma® can assure that all patients are interviewed in a consistent way which is a prerequisite to obtaining reliable and valid data.
  • Having standardised procedures for proper reporting and handling of potential adverse events from interviews, Clinigma® can ensure high compliance with existing safety reporting requirements.
  • Handling patient interviews in accordance with standard operating procedures, Clinigma® can assure the ability to properly document the course of events in the interaction with patients.

In addition to supporting the importance of standardised procedures, the above also illustrates several advantages – i.e. providing a better basis for the collection of high-quality data, ensuring correct handling of potential adverse events, and securing the ability to sufficiently document all actions taken incl. audit trails on all patient interactions. The ability to document the procedures and how they are followed is also very important in the case of GCP inspections and/or audits.

All of this supports why we at Clinigma® care so much about continuously strengthening and structuring our procedures.

Building on our years of focus on patient interviews, we have learned that the patient interview process can be a hassle as it relies on timely and correct actions from many different people at different time points. Yet, having effective and clear standard operating procedures, trained researchers, and a secure IT Portal facilitating the interviews can truly remove the hassle. It ensures that the involved parties are staying well-informed on the actions taken, the tasks completed, and the upcoming actions to take, which is essential for making sure that nothing is left undone.

Would you like to get structured insights on the patients’ experiences with your investigational drug?
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