Compier Aggregate Reports

Home / Innovation / Compier Aggregate Reports

Synchronize and Simplify Drug Safety Aggregate Reporting

Marketing Authorization Holders (MAH) are expected to prepare and submit aggregate safety reports to regional and global regulatory bodies to account for the medicine’s safety profile over an extended period of time. These periodic reports shall be used for assessing the risk-benefit of the product and taking appropriate action where new risks or changes to known risks are identified.

Compier Aggregate Reports

With Compier Aggregate Reports, pharma companies can automate the complete regulatory reporting lifecycle management from pre-approval to post-approval of medicinal products.

It facilitates digital authoring of different types of aggregate reports, online completion of collaborative review and creating a reporting schedule for different regulatory submissions.


Key Product Features

  • Report Schedule Management:Create and Manage global reporting schedules/timetables with calendar trackers.
  • Predefined Templates – Organizations can leverage predefined Aggregate Report templates for various types of reports such as PADER, PSUR, PBRER, DSUR, CTPR or can define templates as per business requirements
  • Digital Authoring: Author reports within Compier without any dependency on third party apps
  • Collaborative Review: Schedule, initiate, and complete report content review with multiple teams and reviewers at the same time
  • Workflow driven activities: Define and configure workflows from scheduling, authoring till submission
  • Regulatory tracking: Acknowledgements received for each submission and amendment can be tracked and reported
  • Access Control: Define controls to who can view, edit, review, approve aggregate reports
  • Version Controlled: Access latest version of aggregate report with archived older versions
  • Auto Update Rules: Auto update modules, templates, schedules and aggregate report based on pre-defined rules
  • Sharing Aggregate Reports: Allows sharing in various formats such as word, PDF, weblink, etc. through various channels
  • Alerts & Notifications: Stay informed on workflow tasks assignment, workflow tasks and related activity updates
  • Insights & Analytics: Ready to use and extendable dashboards, data listings and performance indicators

Seamless Integrations with various source systems to enable 100% process automation

  • Drug Safety Database
  • Signal Management System
  • Clinical Systems
  • Quality Management System
  • Literature Screening
  • Other modules of Compier
  • Other organization wide operational data source systems

Aggregate Reporting is a component of our Compier platform. It can be deployed on its own or in combination with other modules of the platform.

Business Analysis

How Do we Deliver

Our technology platform, process accelerators and subject matter expertise enable you with a comprehensive solution to digitalize and automate the entire compliance associated with aggregate reporting. Our solutions are flexible, modular and can be deployed by MAH, QPPV office and CRO companies globally or at local entities.

New Insights

Enabling eSource in Clinical Studies to Optimize Trial Quality

Source data is all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Electronic data source or eSource is the data that is initially recorded in electronic format in this process. Biopharma and MedTech [...]

Implementing Electronic Consent for Clinical Trial Participation

Industry Background of eConsent In an attempt to address health authority concerns and improve patient confidence, companies and independent industry bodies have experimented with electronic consent (eConsent) using electronic media such as smartphones, laptops, and tablets. Despite positive outcomes, its implementation remained experimental until FDA officially released a guidance in December 2016. Following in FDA’s [...]

Top 4 Trial Design Best Practices for Medical Device Clinical Studies

What drives the growing complexity in medical device clinical trials? The medical devices industry has revolutionized medicine with significant advances in both detection and treatment of diseases. Clinical trials for medical device regulatory approval are designed to produce valid scientific evidence of safety and effectiveness for the intended uses. Moreover, sponsors must consider designing trials [...]

Get in Touch with Us