RQMIS

Data Management and Post Market Study

The Situation

A manufacturer’s Post-Market Study (PMS) suffered from poor data management, while clinical monitoring was handled separately by a Contract Research Organization (CRO).

This disconnect led to incomplete, unverified, and unstructured data, putting the study at risk of being unusable for regulatory and publication purposes.

The Solution

RQMIS took control of the data management process and rapidly restored order and integrity to the study:

Cleaned and reconciled all study data to ensure accuracy and completeness
Implemented a structured query resolution process
Finalized and locked the clinical database
Completed formal study closeout and supported data publication

Within six months, the study was fully closed, with validated data successfully included in the manufacturer’s Technical File (TF) and published in a peer-reviewed journal.

The Situation

Data management for a Post-Market Study (PMS) had been significantly neglected, while clinical monitoring was handled independently by a Contract Research Organization (CRO).

The Sponsor had accumulated two years of data from 30 patients, all captured on paper Case Report Forms (CRFs) with no Electronic Data Capture (EDC) system in place. As a result, the data was unstructured, unverified, and not readily usable for analysis or regulatory purposes.

At the same time, the Sponsor needed to close out the study, generate final reports, update the Technical File (TF), and prepare a manuscript for publication—all under tight timelines.

The Solution

RQMIS stepped in to take full control of data management and study completion, starting with an urgent 3-week deadline to deliver an initial manuscript draft.

To meet this timeline, RQMIS:

Deployed a dedicated Data Management team
Developed a comprehensive Data Management Plan (DMP)
Entered and digitized two years of paper-based data
Created a structured codebook to standardize data

After successfully meeting the publication deadline, RQMIS proceeded to fully close out the study:

Implemented a manual query process to validate all CRFs with investigational sites
Cleaned and reconciled the dataset, followed by a final database lock
Coordinated with the CRO to complete site close-out visits across Europe

In parallel, RQMIS addressed gaps in the study’s radiographic component by:

Re-engaging the radiographic core lab
Ensuring all imaging data was analyzed and integrated into the study

With all data finalized, RQMIS:

Conducted comprehensive clinical and radiographic analyses
Authored the Clinical Evaluation Report (CER) and Clinical Investigation Report
Updated the Sponsor’s Technical File (TF)
Supported journal publication of study results

The Outcome

Within six months, RQMIS:

Cleaned, validated, and locked the entire dataset
Successfully closed out the study
Delivered regulatory documentation and updated the Technical File
Enabled publication of study results

Straight Talk

Unmanaged data doesn’t just slow you down—it makes your study unusable.

RQMIS turned two years of paper chaos into a regulatory-ready, publishable dataset—fast.

Do you need help with data management or study close out?

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