A competent preclinical CRO tests novel treatments or compounds using carefully selected models with proper experimental setups. Time is money: fast delivery of well-documented results without compromising the quality is a must for a customer looking for facts to steer their decisions in the fast-paced business.
In the world of CRO’s, biological expertise and technical skills play a major role. However, already in the study planning phase also statistics must come into play. For example, there is a strong dependency between the required statistical power and the study costs. A common pitfall is to decide the number of test units based on money, not statistical requirements. At Pharmatest, we always perform our studies preceded by a careful design of the entire study. We look for an appropriate and balanced setup that is justified both biologically and from the statistical point of view. This is not only sensible but also ethical.
Analysis and reporting workflow is a sequence of tasks that remains the same from study to study. Pharmatest has taken full advantage of this by developing a fully automated pipeline where high-quality analyses and fast reporting are achieved through automation, which is based on efficient utilization of IT infrastructure. High level of automation makes things fast and straightforward, and eliminates human errors.
At Pharmatest, statistical analyses are run using versioned programs, and the used software configuration is recorded in detail. As a result, any statistical analysis and reporting run is truly and fully traceable – and more importantly – 100% repeatable. Our workhorse in the analyses is standard statistical software. On top of that, we have built tailored software modules that are extremely fast to deploy using minimal amount of study specific configuration work by the statistician. At the heart of those modules, stable and well-established standard statistics libraries are used. Version control of all program codes is carried out using a standard version control tool.
In Pharmatest, a final report appendix containing the raw data and the statistical analyses is today completely produced using automated workflow to the very last detail. Also, figures containing statistical results that are included in the final report are automatically produced. As a part of our quality assurance process, all results are naturally once more checked by the study director before delivering the results to the customer.