Software Solutions for R&D and Regulatory Affairs

Every CLO, CRO or CMO wants to adapt as quickly as possible to each new engagement they win from a sponsor. They need to

  • Manage all the documentation generated from the research and trials
  • Prepare file its first NDA or BLA with or on behalf of the sponsor
  • Collaborate with the sponsor, contract research organization, study teams, doctors, and patients

By providing seamless Collaboration across all parties, trials can proceed smoothly and eventually submissions can be prepared and submitted to regulatory agencies. Having an automated document management and collaboration system to manage research documents, protocols, CRFs, study tagging files, and all other documents related to discovery, makes submissions a relatively easier and more efficient process. Establishing a Quality Management Solution in conjunction with an EDMS for Submission Document Management further enhances the solution by providing a unified platform to also manage study site audits, study deviations, and complaints.

Download this webinar on Managing Successful Submissions and US FDA Audits to hear best practice measures that companies need to have in place to mitigate negative inspection results. With the decision of the US FDA not to accept paper based drug submissions from January 1, 2015, this webinar outlines what you need to do when preparing electronic dossiers for the FDA. It highlights best practices to ensuring accurate submission content to significantly reduce agency approval time.

Alternatively, check out this QUMAS R&D Submission Documents Package from the QUMAS Packaged Solutions, which offers an off-the-shelf approach to R&D Submission Document Management.