Compier Exchange & Reconciliation

Home / Innovation / Compier Exchange & Reconciliation

Compliant Case Exchange and Automated Reconciliation 

A sponsor may have a multiple SDEA with different partners for exchange of safety data for the licensed products. As per these SDEA a sponsor or a partner is responsible for exchange of data in agreed timelines. The data exchanged needs to be further assessed and qualified for ICSR and further submission to regulatory agencies in defined timelines. It is Sponsors or Partners responsibility to further track and share the safety data to different Partners as per SDEA executed.

Additionally, the Sponsor or Partner is responsible for Reconciliation of Safety Data Exchanged to ensure there are no missing Adverse Events which are not shared as per SDEA. Reconciliation is a critical process and time consuming when there are multiple SDEA executed.

Compier Case Exchange & Reconciliation

Case data can be exchanged, and the log can be recorded using the Compier Case Exchange & Reconciliation Module. The case information form is entirely configurable, allowing you to store any type of information relevant to case data or log including capture of both inbound and outbound case information. Time compliance and data quality of case data exchanged can be tracked and monitored during the exchange of data with standard dashboards.

Reconciliation of data exchanged can be auto triggered as per defined timelines in an SDEA / Agreement. Partners can complete the reconciliation by acknowledging via email or login to a portal for review and closure.

Homepage Banner

Key Features

Technology is used to build a high configurable data capture solution to put forward a product eliminating multiple redundant trackers which are used currently by the intake team.
Reconciliation setup is part of PV agreements ensuring no data discrepancy count between various safety databases holding the sponsor information. Reconciliation is auto-generated and shared to make sure the non-discrepancy.
By using Case Exchange and Reconciliation component, both digitalization and Automation is achieved in addition to compliance. You will have oversight to the partner performance with respect timeline, quality and count of missing cases.
  • Configurable Data Capture Forms
  • Tightly Integrated with Agreements (SDEA)
  • Inbound and Outbound Exchange of Data
  • Automated Reconciliations
  • Partner Portal Access
  • Compliance Dashboards and Reports
Business Meeting

How Do we Deliver

Our technology platform and subject matter expertise enables you with a solution to digitalize and automate the Case Intake and Reconciliation process.

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