The Next Generation Model: Breakthrough in Technology Innovation & Process Optimization for eClinical Trails: Rapid Deployment Approach through Flexible System Design

In the pharmaceutical industry, the pressure on small companies to bring innovative products to market versus large competitors is unprecedented. With the desire to decrease the cost of conducting trials, reducing time-to-market and improving their competitive edge, smaller bio-techs and pharmaceuticals will require inventive strategies for building, designing and deploying their studies. With the availability of flexible configurable Electronic Data Capture (EDC) systems that come equipped with pre-configured, pre-packaged and standard offerings, for Phase I and II trails, both study design and development time would be radically reduced. With traditional EDC systems requiring 8–12 weeks to configure, flexible systems that offer pre-packaged, yet modifiable offering to configure, would significantly reduce design and development time by over fifty percent. However, adopting a flexible technology system alone can not resolve this dilemma for speed to market. A well-defined process strategy by the pharmaceutical stakeholders is the remaining ingredient to further reduce costs associated to the long lifecycle of clinical trail development. When time-to-market is critical, the breakthrough of technology innovation and process optimization can streamline and enhance productivity in the eClinical development cycle.

For bio/pharmaceutical companies to succeed in the race for the cure, there must be both enterprise and strategy flexibility within the organization to introduce new methodologies in traditional clinical trial design phases. The more flexibility a pharmaceutical company allows the more resilient and resistant to market threats - and responsive to opportunities - it becomes. In this paper, attempt has been made to map the flexibility in an organization and its impact on performance. Flexibility options and considerations have been outlined using Flexible system tools. The analysis includes SAP - LAP Framework and SAP - LAP Models and Linkages. This paper highlights how a more flexible pharmaceutical business infrastructure can help an organization cut costs, reduce time to market, increase profits - and, perhaps most importantly, prepare for unpredicted challenges in a rapidly changing industry with the use of adaptive trial design.