Electronic Data Capture in Clinical Trials

Our office based Data Managers provide full service from database development to database lock. Our Data Management services are governed by rigorous SOPs and comply with ICH, GCP, and FDA 21 CFR Part 11 regulations. Our products provide the Data Management Team a state of the art, fully compliant EDC system to conduct data review and manage queries in real time. It also ensures data accuracy and integrity with real time reporting.  Our Data Management services are tailored to fit your clinical trial needs: From individual stand-alone services to fully-functional outsourcing.

Services from Inception to Completion:

  • Data Specifications
  • Database Development and Validation
  • Data Management Plan
  • Data Review
  • 3rd Party Vendor Data Reconciliation
  • Dictionary Coding
  • Database Closure
  • Data Transfers
  • eCRF Archival

Process

Database Go-Live Timelines

Contract Award/Project Kickoff Meeting

Day 0

Final Protocol/Database Specifications Reviewed

Day 1

DB Set-up Package Completed

Day 1

Data Management Plan Drafted and Sent to Client

Day 2

Metadata Created

Day 2

Editing Groundrules Initiated

Day 3

Layouts Completed/Including On-Entry Checks

Day 5

eCRF Completion Manual Initiated

Day 6

Release for CDM Entry Testing

Day 7

Final Annotated For Entry CRF Printed/Entry can Go-Live

Day 8

Export Views

Day 9

eCRF Completion Manual Completed

Day 9

Editing Groundrules Completed

Day 9

Edit Check Programming Initiated

Day 10

Validation of Export Views

Day 11

Test Plans Completed

Day 11

Final Annotated CRF Printed/Test Transfer Available

Day 13

Validation Completed and Documentation Compiled/Edits can Go-Live

Day 15

Ready for Client UAT/Sign-off

Day 16

Services from Inception to Completion:

  • Data Specifications
  • Database Development and Validation
  • Data Management Plan
  • Data Review
  • 3rd Party Vendor Data Reconciliation
  • Dictionary Coding
  • Database Closure
  • Data Transfers
  • eCRF Archival

QDS’ refined data review process has shown

>88% reduction in queries!

E-Clinical Software Company

Clinical trials are complex undertakings that generate an enormous quantity of data. What’s more, the information generated is often extremely valuable. Data management in clinical research is, therefore, vital. Data managers need clinical trial management systems that provide electronic data capture, helping them bring down costs, reliably collect data, and secure it for data analysis later.

Electronic data capture companies are organizations that provide electronic data capture systems for clinical trials. They use advanced techniques to reduce the burden of data management in clinical research and deploy their specialist knowledge to ensure data integrity and reliability. The result is a set of data that accurately reflects the reality of the study, no matter what that happens to be.

Additional Information

Our Process for Data Management in Clinical Research

If you are looking for data management CRO, then you have come to the right place. As an eClinical software company, we provide all the tools that data managers need to collect and store data reliably. From the outset, we embark on a robust and tailored process that ensures full scientific integrity.

Just like any data management CRO, we begin with a review of your protocols and database specification. This part of the process tells us the databases that you will populate with the results from your trial. We then create a data management plan that uses electronic data capture systems for clinical trials. This plan lets us construct metadata, tagging data that you will ultimately collect in the course of your research.

As an electronic data capture company, we then consult with you on the editing ground rules, which is particularly important in clinical safety data management. After that, we complete layouts, including on-entry checks.

The next stage is to create the appropriate electronic case report forms. Electronic data capture companies need to develop forms that apply to specific clinical trials and offer the correct formatting and data entry options. With the proper formats, electronic data capture in clinical trials is considerably easier for data managers.

Our data management CRO team then embarks on a series of internal checks and plans testing before releasing live editing tools to clients.

As an electronic data capture company, we see it as our mission to ensure that researchers have robust tools for electronic data capture in clinical trials. That’s why we work closely with labs every step of the way and, at the same time, provide real-time updates, setting us apart from other electronic data capture companies. With our services, you can cut down on time you spend undertaking data management in clinical research and focus more extensively on testing your theories and compiling results for publication.

As a data management CRO, we cater to the full life cycle of your data needs. Not only do we provide you with a data management plan and third-party vendor data reconciliation, but we also offer database closure. This is something that is essential for data management in clinical research and that many data management systems for clinical trials do not do.

It is also essential for an eClinical software company to provide archiving facilities. That’s why we offer eCRF archival so that data managers can store original records safely until other researchers require them.

Electronic data capture systems for clinical trials are becoming increasingly vital for researchers having to construct complex data sets reliably and robustly. Greater scrutiny of results is also making data management systems for clinical trials even more imperative. Laboratories and research institutions that do not use electronic data capture companies run the risk of missing data and losing funding.

Thus, data management in clinical research is more critical than ever before. Clinical trials that do not use an eClinical software company could find themselves in a situation in which they cannot effectively manage their data, slowing the rate at which it is collected. They also run the risk of errors and omissions when they don’t use data management systems for clinical trials, causing them to draw the wrong conclusions, which may have implications for patient safety.

Improve Your Data Management with QDS

If you are conducting a clinical trial, our electronic data capture company can help. Electronic data capture in clinical trials is now more critical than ever. We are an eClinical software company that follows a robust data creation and processing, providing an end-to-end service for your clinical trial. Through a combination of data specifications, database development and validation, dictionary coding, data transfers, and eCRF archival, we are the only eClinical software company you need