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Data Management and EDC Setup For Medical Device Clinical Trials
Why Companies Choose NAMSA
Medical Device & IVD Clinical Professionals on Staff
Databases Developed and Supported Last Year
Weeks on Average to Build Out a Database
Sponsors Trust NAMSA to Get It Right the First Time
Bringing a new medical device or In Vitro Diagnostic (IVD) to market is a huge investment and much of the expense comes from gathering clinical data. The success of your regulatory submission is highly dependent on the quality and accuracy of your trial data. NAMSA can help ensure that your clinical investigations meet ISO 14155, 21 CFR Part 11 and other applicable regulations for data completeness, accuracy and security. Here are some quick facts about data management in clinical studies:
- Section 7.8 of ISO 14155:2020 (GCP) lays out “Document and data control” requirements.
- In the US, compliance with data requirements in 21 CFR Part 11 and HIPAA are mandatory.
- In the EU, the General Data Protection Regulation (GDPR) includes strict data requirements.
- A validated Electronic Data Capture (EDC) system is essential for clinical data management.
- Ensuring data integrity and quality is a critical aspect of data management this includes insufing the completeness, accuracy, and reliability of the data throughout the lifecycle of the clinical trial.
A Full Range of Data Management Services
NAMSA offers a full range of clinical research consulting solutions for comprehensive data management and support, delivered by our experienced clinical data managers and clinical database developers. These team members, cross-trained and integrated with our clinical study management and biostatistics teams, provide services ranging from design and database development to data cleaning and monitoring support. Data management services we provide include:
- Data Management Plan (DMP) development – The data management plan describes the processes and procedures used in the database development, database use, and management of data.
- Case Report Form (CRF) Revision or Design – We offer expertise in creating or revising Case Report Forms (CRFs) to align with your study’s data requirements. With years of experience in both data management and clinical research, the NAMSA team can review your study protocol, identify necessary data points, and design CRFs that facilitate easy data entry for sites.
- Electronic Data Capture (EDC) Development and System Implementation – Our database development team can work on a variety of EDC platforms to support your clinical trial. Our team offers the ability to build in extra modules such as randomization, monitoring, WHODrug, ePro and eConsent.
- Standardized Templates and Forms – Our team utilizes standardized templates and forms that align with regulatory guidelines streamlining database development and data management thereby boosting data management efficiency and quality.
- Data Transfer – NAMSA offers the ability to transfer EDC data to Sponsor at a predefined frequency as defined in the Data Transfer Specifications.
- Data Cleaning – Within the DMP, the data review guideline includes detail concerning the types of data cleaning to be performed, frequencies, and other related details concerning the data management function. To maintain data integrity, data entry training guidelines are provided to sites and validation are used to identify and correct errors or inconsistencies.
- Database Closeout – At study closeout, after all data is entered, queries resolved, form signed, etc., we will lock and archive the database. In addition, the NAMSA team will export the data for final submission and secure storage.
Clinical Data Management and EDC Services by Stage
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