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Innovative Solutions

Innovative Solutions in Clinical Research

Innovative solutions offer our clients tools to assist them in achieving their goals. Our Innovative solutions in clinical research combine the expertise of our extensive global network of talented, experienced professionals in clinical study development, training, reporting and project management, with the latest proven technologies to meet the specific needs of different clients. 

 

Decision Support Systems

 

Maximax, our subsidiary, is a niche provider of computer-based tools to optimize market performance and enable decision makers to foresee future outcomes. Maximax leverages the concepts and theory of resource based strategy delineated by professors David J. Collis and Cynthia Montgomery. The application of these concepts leads to a powerful framework for decision support systems.

 

At the center of each system is the value maximizing function based on identifying demand and supply functions and competitiveness using:

 

 

Lean Six Sigma

 

We utilize the powerful tools of the six sigma process in supporting our projects. Our Standard Operating Procedures (SOPs) are based on six sigma and failure modes analysis to make sure we deliver superior quality services:

  • Six Sigma is a process that is metric and based on the statistical measure called standard deviation, expanded to world class quality providing a better product or service, as well as faster and at a lower cost than our competition

  • Sigma is a term used in statistics to represent standard deviation, an indicator of the degree of variation in a set of measurements or process.

  • Six Sigma is a statistical concept that measures a process in terms of defects at the six sigma level; there are only 3.4 defects per million opportunities which means, at this level, the process is working nearly perfect.

  • It is also a philosophy of managing that focuses on eliminating defects through practices that emphasize understanding, measuring and improving processes.

  • The Six Sigma methodology can be understood as a formal approach of efficiently and effectively managing business, achieving process improvements and solving problems and its philosophy is focused on process control and improvement by the usage of statistical tools.

  • Maximizing performance and gaining a competitive advantage is actually obtained by reducing operational costs. Reducing costs is highly correlated with increasing quality at different levels.

  • The revolution that Six Sigma brings involves a scientific and repeatable fact-based methodology that enables organizations to measure process improvement

 

 

Managing Currency Fluctuation Risks in International Clinical Trials

 

The number of clinical trials conducted globally, as well as the number of countries involved in each study, is increasing at a rapid rate. This trend is imposing significant planning and budgeting challenges for clinical study planners, on top of the numerous existing issues related to understanding cultural and healthcare practices around the world.

New complications can have profound cost impacts, including:

  • During the gap in time between clinical study budgeting and executing (often times, a full year), elements can change (the scope of the trial, the currency strength, etc.) but the budget remains the same. This often leads to wasted revenue and/or resources.

  • In almost all cases, budgets are planned in one currency, the currency of the sponsor company. However, the financial operation and contracts are subordinated in several other currencies, typically the currencies of the countries where the trials are conducted. Therefore, initial financial plans for the study will have to absorb any fluctuation in exchange rates to meet obligations incurred in the initially established contracts.

  • Currency volatility risks are managed by multinational corporations via large departments that use sophisticated tools and hire financial experts. However, most companies that sponsor clinical trials are small to mid-size and they have neither the resources nor the expertise to manage currency risk fluctuation. This is a rather new discipline to the clinical trials industry andn typical practice, decision makers are mostly drug development researchers or medical directors, or trials’ managers with little exposure to this field.

 

An emerging clinical trial method that addresses these issues is Currency Risk Management (CRM). The CRM method features planning steps that use commercially-available clinical trial software systems to build a simple iterative planning model for managing financial operation.

Currency Risks

Currency Risk Management Summary

Currency Risk Case Study