Alzheimer's disease is a very difficult disease to treat, and the field is crowded with companies hoping to see success with their treatments.
Pentara Corporation specializes in Alzheimer's disease clinical study design and efficacy analysis with at least 95% of Pentara's business devoted to the planning and implementation of efficacy analyses in Alzheimer's disease.
The reason for this highly specialized approach is that Pentara is a small company, and the field of Alzheimer's disease is progressing rapidly in terms of measurement of disease, population selection and efficacy analysis.
In order to be the very best at what we do, we have restricted ourselves to a field in which we can be on the cutting edge and offer our customers the reassurance that at the end of their clinical trial
-- whether it fails or succeeds --
they don't have to question whether they have measured the right outcomes and analyzed them in the best way.

We want them to be able to present results to outside audiences in a compelling way in order to move forward with confidence that decisions have been based on solid scientific evidence.

Pentara has two different business arrangements that suit the needs of their clients in the Alzheimer's disease field. The first is an arrangement where the primary service performed by Pentara is improving the planning of the clinical trial by optimizing the population selection, the efficacy outcome measurement and calculation, and the statistical analysis of the efficacy outcome. This arrangement is appropriate when a company has experience in Alzheimer's disease, but wants to venture into a new population, consider a new outcome, or improve the analysis methods in order to be more confident that the study design being planned is customized to the new project being considered. In most of these cases, the company is performing their own statistical analyses, programming their own tables, figures and listings, and has a staff that are either already experienced with Alzheimer's disease, or ready to become experienced as part of a long term commitment to this field. Often, these types of arrangements lead to publications or presentations of the results in order to share the insights learned with the field.

The second type of arrangement is one where the primary service performed by Pentara is the production of efficacy tables, and figures. This arrangement is more appropriate when a company is new to Alzheimer's disease and is performing a study in a population that is already well-studied with an outcome that is standard. Pentara has standard tables and figures that reflect the best approaches currently used in the Alzheimer's disease field. As the field progresses, these standard tables and figures are updated to reflect current thinking. The analyses in this case are likely to be traditional, with some updating, and Pentara would assist in writing the analyses into the protocol (along with calculation of the sample size) and the statistical analysis plan. In this case, the production of all of the tables, figures and listings can be performed by Pentara Corporation, but it is important that the efficacy analyses are performed by Pentara*. A combination of the two approaches may be desired, particularly in the case when the company is interested in optimizing the analysis or the outcomes for the specific study being planned, but when most of the aspects of the study design are standard.
*In the past, Pentara has offered the option of writing the protocol statistical section and the efficacy analysis section of the statistical analysis plan in cases when all analyses -- efficacy and non-efficacy -- are being performed by an outside group, but this has not proven to be in the best interest of our clients. In some cases, the outside companies performing the analyses have not performed them in the intended way, or have made decisions about the details of the analysis that were not consistent with the plan and the result was that the company was unsure whether the inconsistencies in the results were due to lack of a treatment effect or due to the decisions made during the analysis process.

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