Life Sciences

Today, Life Science Organizations face tougher challenges than what they faced ten years ago. Starting with newer and stricter Government policies the other challenges such as increasing competition from global companies, longer cycles on regulatory compliance, shorter time to market and pressure from consumers and competition to continuously develop and launch newer products.

Since early 1999, a group of researchers and scientists immersed in the world of clinical trials, but frustrated by the limitations of the data capture tools available, united to develop a revolutionary solution. Their goal was to create a powerful Electronic Data Capture (EDC) system that would improve productivity and workflow, yet be easy to learn and use; something sophisticated enough to be simple.

Paradigm Solution to Life Science

Paradigm has long been a solution provider to the Life Sciences Industry especially in the following areas of engagement for Clinical development: Clinical Data Management, EDC and Regulatory Submissions.

Paradigm has worked with some of the leading Clinical Data Management companies and has actively participated in the customization and implementation of the products in accordance with the customer requirements. While many products are available in the market for managing clinical data, solutions from Mediata Solutions Inc, founded by clinical research professionals are written specifically to address some of the challenges faced by Clinical Research organizations.

Paradigm has worked closely with Medidata on their RAVE™ product line. Every implementation of a RAVE™ requires it to be configured as per the client’s specific Data Management Plan (DMP) provided for every research trail. Business rules for a trial are implemented using the Edit checks that are built as per the Data Management Plan. The complex business rules are created using Custom Edit checks. Paradigm has been involved in developing these custom edit check procedure creation and unit testing. Apart from these, Paradigm has also been involved in creating custom scripts for modifying the data and resolving some of the production issues related to Custom Edit checks.

For more information on our Life Sciences Practice, please download our detailed datasheet