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SMW covers the topics from study design to finalised study report


Clearly, two core business operations of pharmaceutical companies can benefit from the services offered by SMW Consultants: 1) Getting their new drug to market, and 2) Marketing a licensed drug. In both cases, your company is dealing with significant financial issues.

Getting a drug to market

Not infrequently, the key obstacle of getting a new drug to market is the delay in receiving the approval of the regulatory officials. Needless to emphasize, any such delay means significant financial losses to the company.

Sometimes the reasons for delaying the approval are clearly beyond the control of your company. However, an important reason for such a delay can be insufficient, inaccurate or slow reporting of the results of the required clinical trial(s). This is clearly the cause that should not be beyond the control of your company. And this is also an area, where SMW Consultants can enter the scene.

Accurate and timely completion of the clinical study reports (CSRs) is clearly the key to avoid the delays in the approval process of your new drug. SMW Consultants are prepared to offer you assistance in making these reports on time and fully compliant with the requested guidelines.

Usually, the bottleneck in completion of these CSRs on time is the statistical analysis and presentation of the trial results. The optimal solution might be to let a single team to complete the statistical analysis and the writing. That would guarantee that the results and their presentation are in line with the report text, making it concise, clear and informative.

Sometimes, unfortunately, this stage is too late to prepare the errors, if the study design (including the sample size estimation) were not correctly done. In such a case, there is no statistical means to correct the errors made in the sampling, and the trial results might remain seriously biased. The worst scenario is that the company needs to design a new trial, with extreme increase in costs.

In case of any doubt, it is highly advantageous to approach SMW Consultants at an early stage of planning the trial design. Such an approach would comprise a review of your study design, controlling its statistical power, and instructing which type of statistical tests would be advisable. Needless to emphasize that taking this step can safe you a lot!

Marketing a licensed drug

Getting a license, does not automatically guarantee that the newcomer will become a great success story. To make it such will necessitate a substantial additional effort. This is another area, where the expertise of SMW Consultants can safe you a lot of costs.

To fully exploit the sales potential, it is essential that the benefits and advantages of the new drug become to public awareness. In other words, the efforts made in the clinical development program will not be rewarded, if the potential users remain unaware of the benefits of your drug. Increasing this awareness means presenting the efficacy, safety, and pharmacokinetic documentation but also analysis on the impact of the treatment on health economics.

SMW can assist you in planning a communication strategy for your product. In simple terms, you need to develop an effective strategy how to communicate the undeniable benefits of your product to the most appropriate audience in the most cost-effective way. SMW Consultants can exploit its experience of communicating this type of information through different channels, i.e., conference abstracts, presentations, or internet publishing.

From the scientific point of view, none of the above measures can replace a timely original publication of the data. Writing these original reports for your company would be our privilege.


SMW Consultants Ltd.

Writing & Consulting Medical Research

Kylliäisentie 9, FIN-21620 Kuusisto, Finland













































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