Continues its Growth Journey with a Focus on Quality

The consulting company APNC Sweden specializes in high-quality medical statistics for life science research as well as the development of prediction models for evidence-based medical and clinical research.

– We support both academia and the pharmaceutical industry with tailored statistical solutions in four areas: biostatistics, bioinformatics, training, and prediction modeling using machine learning methodology, says Aldina Pivodic, CEO and founder of APNC Sweden.

The growth journey that APNC Sweden has made over the past two years at GoCo Health Innovation City in Mölndal is both striking and impressive. Aldina Pivodic has gone from being a sole proprietor to leading a consulting company with 14 employees. The company is now continuing to grow through its establishment in Medicon Village in Lund in order to be closer to customers in the region.

– The establishment is a natural step. We already have several customers in southern Sweden, and by being on site a couple of times a month we become more visible, especially to smaller companies. Our presence also makes it easier to network with research groups in academia, as well as small and medium-sized companies, which are our primary customers, continues Aldina Pivodic.

Although APNC Sweden is a smaller company, it has placed great emphasis on building a stable organization and a clear structure that is usually found only in larger companies. Through both permanent employees and consultants, APNC Sweden has an organizational structure that includes everything from HR and a Financial Advisor to a Data Protection Officer (DPO). To further strengthen the company’s quality management and ensure high quality in all of the company’s services, APNC Sweden has over the past year initiated extensive work to build a Quality Management System (QMS).

– A QMS is based on Standard Operating Procedures (SOPs), documented step-by-step instructions, that standardize work processes and ensure that tasks are performed in a consistent manner, which helps maintain and continuously improve quality, explains Aldina Pivodic.

– Our customers should feel confident in the way we work. Regardless of who at APNC is responsible for the customer’s project, the process, execution, and result should always maintain the same high standard.

Appointed a QA Manager

Responsible for the company’s QMS work is Annika Wennersten, QA & Operational Support Manager, who has more than 25 years of experience from the tech and pharmaceutical industries, including clinical trials, database management, and programming.

– During the first two years, most of our customers were in academia. But now, as we take on more assignments for pharmaceutical companies and also the tech industry, we need to demonstrate that we meet the high quality and compliance standards required by industry, says Annika.

In collaboration with the employees at APNC Sweden, and the company’s DPO, Annika has developed SOPs covering the work of the entire organization, from planning, programming, and statistical analyses to data management, regulatory processes, and HR matters.

– We now have SOPs down to a detailed level for how we are to perform our work tasks, all to ensure that our work is as consistent, efficient, and secure as possible. We have, for example, an SOP for how we handle our data and ensure that it is transferred in a secure and consistent manner. As part of this, there are also control procedures for work processes and the material sent to customers, says Annika, who in her operational role maintains ongoing dialogue with employees.

Assignments in the pharmaceutical industry generally require more documentation, including in the regulatory process, than assignments in academia, but do not always involve equally complex statistics.

– Generally speaking, academic projects require a highly skilled statistician, as we are often involved from the outset all the way through to publication, whereas assignments in industry require greater knowledge of regulatory requirements for the planning, execution, and documentation of studies, as well as data reporting.

ISO 27001

The next step in APNC Sweden’s quality management work is to certify the company according to ISO 27001, the international standard for information security management systems (ISMS), which provides a framework for how an organization should systematically manage, protect, and continuously improve its information.

– When we started the process in 2025, we were told that it is unusual for companies focused on statistics to become certified according to ISO 27001, but we see it as a given in order to ensure the quality of our work. Quality is one of our two guiding principles that we work by and that permeates our operations, says Aldina Pivodic.

– The other guiding principle is well-being. To achieve quality, our employees must feel well and have the right conditions to perform their work in the best possible way.