Essential Elements Of A Data Management Plan For Outsourced Drug Development

By Bikash Chatterjee

Bringing innovative and life-sustaining drugs to the world is the mission of the pharmaceutical industry, but historically, the time, cost, and effort to bring new drugs to market has been a challenge, with only 13% of all drugs in development taking up to 10 years to be launched commercially. However, the global need for a COVID-19 vaccine redefined the rules of drug development. The benefits of harnessing data efficiently and effectively have never been more apparent. To most pharma organizations, that means establishing a digital integration or transformation strategy and linking that to a comprehensive data management plan.

As drug sponsors extend the development and manufacturing enterprise to include CDMO partners, the ability to rapidly and accurately share access to relevant data can have a profound impact on both time to market and simplifying program decision-making. Understanding the key characteristics of an effective data management plan as they relate to contract service providers is important in developing an effective data management plan.