Agile Approach to Overcome Evolving Challenges Faced by Statistical Programmers During Clinical Reporting

• Activity Number: 111
• Type: Topic Contributed
• Date/Time: Monday, August 1, 2011 : 8:30 AM to 10:20 AM
• Sponsor: Section for Statistical Programmers and Analysts
• Author(s): Vikash Jain*+
• Companies: eClinical Solutions
• Keywords: Statistical ; Programmer ; Agile ; Clinical ; Reporting ; quality

Abstract

Evolving industry standardization, global competitiveness and economic downturn are driving many pharmaceutical and biotech companies to look into strategic approaches to adopt business models of outsourcing or off shoring or blend of both for their clinical programming operations for reduced cost, maintain quality and minimal turnaround time on their reporting. With such strategic influences our paper will specifically focus on how the statistical programmer's involved in reporting phase are challenged when interacting with external cohesive departments and also challenged internally with in their programming team in operational aspects when most of them are dispersed domestically and/or globally. This paper outlines challenged scenarios faced at various avenues during their course of trial reporting either an individual study or a submission and how they can adopt to such situations proactively by incorporating continuous evaluation & adjustment, subjective judgment with agile thinking and understand their own shared purpose, goal and accountability with in their organization and also with external partnership to maintain the integrity of quality and relationship in a long run.