Statistical Expertise Promotes Accurate Study Management
Founded by former AstraZeneca statisticians, StatMind offers companies statistical expertise regarding design of study programmes and data mining, as well as retrospective analyses and modelling of PK/PD relationships.
StatMind was founded in 2011 by former AstraZeneca colleagues, and is now co-owned by Thomas Bengtsson and Stefan Peterson. The company, which is situated in Medicon Village since 2013, provides statistical competence to pharma and medical device projects. At AZ, Thomas and Stefan gained comprehensive expertise in respiratory R&D, but they have also been involved in projects concerning diabetes, pain relief, haemophilia and oncology.
”We help our customers to design their study programmes, as well as with retrospective analyses, data mining and communicating with regulatory authorities. We also provide high-quality analyses of pharmacokinetic and pharmacodynamic studies, as well as modelling of PK/PD relationships,” says Thomas Bengtsson.
Apart from their strong base in PD studies, their customer cases also involve bioequivalence, therapeutic equivalence and regulatory aspects.
”We’re unique in the sense that we can supply both PK computations and perform the statistical analysis of the parameters. We have the additional insight gained by strong statistical methods and experience” he adds.
They’ve also been engaged in register studies.
”Sweden has a veritable goldmine with its high-quality and comprehensive records,” Stefan Peterson comments.
Provides Project Risk Reduction
When a company comes to StatMind it may already have started to conduct a regulatory study. But StatMind advises companies to involve a statistical expert earlier in the process to ascertain that the proposed study can answer the primary objective as intended, for instance a proper sample size calculation is needed.
”Otherwise, parts of a study may have to be re-run due to criticism from regulatory authorities. In that sense our services provide risk reduction for a project,” says Stefan Peterson.
StatMind can also be a complement to a traditional CRO, and act as project statisticians and advisors to the sponsor while the CRO analyse the data. In some projects they’ve also been a scientific support for medical advisors.
”We’re flexible and work with different tools to find effective solutions for each customer. Our primary focus is on small studies in early phase trials, but also explorative studies. By visualising our results we make them more accessible,” he adds.
StatMind is also a member of the Medicon Valley Inhalation Consortium (MVIC), a registered company jointly owned by its 24 member companies. It acts as a full service CRO specialised in inhalation product development.
”For each project, MVIC forms a project team with members allocated from the various member companies as appropriate and in a way that is fully seamless to the client,” Thomas Bengtsson concludes.