Novellas Healthcare achieves ISO 27001 certification for its digital healthcare solutions
Raising the standard for secure digital Patient Support and Early Access Programs
Digital healthcare solutions increasingly sit at the heart of complex pharmaceutical programs. From managing an Early Access Program or Medical Need Program to supporting patients throughout a Patient Support Program, digital platforms can facilitate interactions between pharmaceutical companies, healthcare professionals, support teams and patients.
But with greater digitalisation comes greater responsibility.
Today, Novellas Healthcare is proud to announce an important milestone: Novellas Healthcare has achieved ISO/IEC 27001 certification, following an intensive certification journey of several months supported by Cranium.
For our clients, partners and teams, this is much more than another certification.
It demonstrates that information security, risk management and robust digital governance are embedded in the way we develop and operate our healthcare solutions.
What does ISO 27001 certification mean for pharmaceutical companies?
ISO/IEC 27001 is the internationally recognised standard for Information Security Management Systems, or ISMS.
It provides a structured framework for identifying information-security risks, implementing appropriate controls, managing responsibilities and continuously improving the way sensitive information is protected.
For pharmaceutical, biotech and medical device companies, this becomes particularly important when digital solutions are integrated into programs involving patients, healthcare professionals, treatment access, program documentation or operational healthcare data.
The objective is therefore not simply to build an efficient digital platform.
It is to create a digital environment where security, governance, quality and operational performance are considered together from the start.
Our ISO 27001 certification reinforces this approach.
Secure digital infrastructure for Early Access Programs and Medical Need Programs
Early Access Programs and Medical Need Programs can involve complex operational workflows.
Patient eligibility needs to be managed. Healthcare professionals may require controlled access to documentation. Medication supply has to be coordinated. Approvals and requests need to remain visible. Program teams need reliable oversight throughout the process.
Novellas Healthcare has developed its e-Medical Need Program solution specifically to help life sciences companies structure and manage these activities digitally.
Our platform can support functionalities such as:
- online patient registration
- healthcare professional access
- patient eligibility and approval workflows
- medication supply monitoring
- management of upcoming supply requests
- access to relevant program documentation
- real-time program visibility and statistics
- structured operational follow-up
The result is a more transparent and manageable environment for sponsors and healthcare professionals.
With Novellas Healthcare now ISO 27001 certified, these capabilities are supported by an information-security management framework designed around structured risk management and continuous improvement.
Bringing the same digital standards to Patient Support Programs
The impact extends beyond Early Access.
Digital technology has become an important component of modern Patient Support Programs (PSPs).
At Novellas Healthcare, our PSP approach combines human support with digital engagement. Depending on the program, this can include nurse-led support, patient education, adherence initiatives, HCP coordination, remote communication, reporting tools and digital patient engagement.
Our digital ecosystem can support PSP portals, patient and HCP communication, adherence reminders, educational content, program monitoring and coordination between the different stakeholders involved in the patient journey.
And because these environments can involve sensitive information, digital innovation cannot be separated from information security.
For us, the equation is straightforward:
Patient centricity + healthcare expertise + digital innovation + information security.
That combination is increasingly becoming essential to building scalable and trustworthy patient solutions.
Months of work behind one important milestone
Achieving ISO 27001 certification required an intensive journey involving the assessment and strengthening of processes, responsibilities, risk-management practices, policies and information-security governance.
The project was supported by Cranium, whose expertise accompanied Novellas Healthcare throughout the certification journey.
Internally, the certification also reflects the close collaboration between quality and digital expertise.
Inge Wyns, Quality & Compliance Manager, and Bjorn Vereecken, Digital Solutions Architect, played central roles in translating rigorous information-security requirements into an operational framework adapted to Novellas Healthcare and its digital healthcare activities.
It is precisely this combination of Quality, Compliance and Digital expertise that matters.
Healthcare technology cannot be approached purely as an IT project. It needs to fit within a broader pharmaceutical environment where quality systems, operational processes, privacy, patient safety and compliance all interact.
Quality and information security working together
Novellas Healthcare already operates its Patient Solutions activities within an ISO 9001-certified quality management framework.
Adding ISO 27001 represents another important step in the maturity of our organisation.
ISO 9001 provides a structured approach to quality management, while ISO 27001 establishes a framework for managing information-security risks.
Together, they reinforce an approach where quality and information security are not treated as afterthoughts, but as fundamental components of healthcare program delivery.
For pharmaceutical and biotech companies selecting a partner for Patient Support Programs, Medical Need Programs or other digitally enabled patient solutions, this provides an additional level of confidence in the infrastructure and governance behind the service.
Digital healthcare should solve complexity, not create more of it
The best healthcare technology is not necessarily the technology with the longest list of features.
It is technology that solves operational problems. A pharmaceutical team launching an Early Access Program needs visibility.
A program manager running a PSP needs reliable workflows.
Healthcare professionals need intuitive access to the information and actions relevant to them.
Patients need a simple and appropriate experience.
Quality and compliance teams need structured processes and governance.
And information needs to be managed securely throughout the ecosystem.
This is the philosophy behind Novellas Healthcare’s digital solutions.
We combine more than 25 years of life sciences expertise, local healthcare knowledge, patient solutions capabilities and digital development expertise to create solutions built specifically around real pharmaceutical and healthcare workflows.
ISO 27001 certification is another step in that direction.
Not digitalisation for the sake of digitalisation.
Digital healthcare built for the realities of life sciences.
Looking for a secure digital solution for your next PSP or Early Access Program?
Whether you are preparing an Early Access Program, Medical Need Program, Compassionate Use Program or Patient Support Program, Novellas Healthcare can help you combine operational healthcare expertise with secure digital capabilities.
From program design and implementation to HCP workflows, patient support, logistics, monitoring and digital program management, our teams can help you build the right solution around your objectives.
Want to explore what this could look like for your next program?
Contact us to discuss your digital Patient Solutions needs.
