EDC-Data Management

Electronic Data Capture (EDC) is the industry standard for collecting clinical data for site-based commercial and non-commercial research. McDougall Scientific offers EDC solutions across a range of needs, from partnering with high-end commercial EDC vendors such as NexTrials, to economic in-house alternatives. Our fully-certified Clinical Data Managers have experience with multiple EDC solutions, including certification for NexTrial's Prism® software.

Whether electronic or paper, McDougall's focus on quality is the reason you can Trust the Data. We ensure the quality of your data throughout its lifecycle; from data entry, through validation, coding, and database lock, your data are kept secure and handled with the utmost care.

Our web report system allows you to stay up-to-date on the progress of data management activities and site enrolment with 24/7 access to real-time metrics through a secure, trial-specific website. Key features include enrolment status, randomization and drug supply monitoring (with the use of a McDougall IVRS), form tracking, and data discrepancy trends.

All data management activities are supported by compliance-driven Standard Operating Procedures that include Quality System checkpoints and audits, ensuring your trust in the data. Highlights of our services include:

Case Report Form (CRF) Consulting and Development: CRF design, based on CDASH (Clinical Data Acquisition Standards Harmonization) standards for either paper-based or EDC trials, that ensures efficient data collection, entry, and analysis.

Data Entry: All data for paper-based trials are double-entered into validated, audit trail enabled databases, and subjected to meticulous quality control.

Medical Coding: Adverse Events (AEs), Medical History (using MedDRA ), and Concomitant Medications (using WHODrug) are coded by qualified personnel. Other dictionaries can be accommodated upon request.

Contact Us to learn more about how our EDC and Data Management Services
can help you.

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