Why Combining Performance, Oversight, Risk and Compliance are very important for your Clinical Development?

   Nov 12, 2018

Unfortunately, most sponsors and CROs use multiple applications to manage their clinical studies. Integrating multiple applications may be challenging for example reporting through multiple apps, managing data & content across systems, limited collaboration, ease of use, Compliance with standards and the list goes on.




Why sponsors should opt Configurable IRT system, before opting any custom version?

   Nov 05, 2018

Clinical trials are more complex than ever and a robust, reliable & cost efficient clinical supply strategy is vital more than ever before. The number and complexity of issues affecting supply chains have also grown to include costly comparative drugs, intricate protocols, delicate investigative compounds, adaptive clinical trials




Are You Aware of Other Countrie's Regulatory Requirements?

   October 29, 2018

To enter into a market, biopharmaceutical companies should have information of local regulations irrespective of the type of drug. Tracking the local regulations of semi and non-regulated markets are the biggest challenges for an affiliate as there would be certain changes expected frequently in regulatory world.




Start small and smart with Labeling Automation

   October 01, 2018

Companies who did large implementations have all noticed their costs and timelines doubled than what is budgeted initially. Yet, PwC's 2017 effectiveness benchmark report found that users spend half their time focused on mundane, repetitive tasks of gathering data from various systems. This led to many of the systems reaching the point of diminishing returns.




How are you managing your medical devices Regulatory Information?

   October 01, 2018

Is your team still using Excel sheets, or other functional teams tools (such as registration trackers or ERP) to manage your global regulatory Health Authority / Notified Body compliance activities? Learn why these tools pose either compliance or business risks if you manage your regulatory activities.




 

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