SMERUD’s data management unit is responsible for delivery of high-quality data that are validated as per regulatory requirements and industry standards. Our team will develop an electronic Case Report Form (eCRF) based on the Clinical Study Protocol, and build the appropriate clinical database specific for the study and fully tested and documented by SMERUD according to defined SOPs. The clinical database is designed and specifically adjusted for each particular clinical trial, so that data entry is facilitated. Reliable checks are implemented in order to assist with data verification. The database is fully tested by several professionals, including an independent data manager and a statistician, before a final validation step allows the database to go live.
During the clinical implementation of the study, our Data Managers validate the captured data, reconcile them and manages the query generation and resolution process. Data will be coded as per medical dictionaries (MedDRA and WHODrug).
Data management services includes:
- eCRF design
- Database and Application Design and
- Data Handling Manual
- eCRF Training
- Data Coding
- Data Verification
- Data Listing
- Data Formatting
- Data Archiving
- Data Management Report
- Data Query Resolution
- Final Database QC and Error Rate Review
Electronic Data Capture (EDC) systems
SMERUD has selected Viedoc4™ as our currently preferred and recommended electronic data capture (EDC) system. Viedoc is a service over the internet system for managing Case Report Form (CRF) data in clinical studies and patient registries. Viedoc is an Electronic Data Capture (EDC) system that enables easy data capture, management, validation and presentation of clinical trial data. Viedoc is a Software-as-a-Service (SaaS) accessed directly through a web browser and requires no installation. It is intuitive and user-friendly and enables efficient sharing of information. Viedoc is a study centric system, that is, all the functionalities are more or less related to a specific study.
The main functionalities provided by Viedoc are:
- Data handling
- Randomization and Trial Supply Management (RTSM)
- Data review/Monitoring
This data management system is fully validated against a regulatory test suite including i.a.:
- EMA eSource Reflection Paper Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials
- EU GMP Annex 11: Computerised Systems
- EU Clinical Trials Regulation 536/2014 Clinical trials on medicinal products for human use
- EU Directive 2001/20 Good Clinical Practice in the conduct of clinical trials on medicinal products for human use
- EU Directive 2005/28 Principles and detailed guidelines for Good Clinical Practice as regards investigational medicinal products for human use
- ICH-GCP R2 Guideline
- FDA 21 CFR Part 11 – Electronic Records; Electronic Signatures
- FDA 21 CFR Part 312 Investigational New Drug Application
- FDA A Risk-Based Approach to Monitoring Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring
- FDA CSUCI Computerized Systems Used in Clinical Investigations
- FDA EHR Guidance Use of Electronic Health Record Data in Clinical Investigations
- FDA eSource Guidance Electronic Source Data in Clinical Investigations
- FDA Mobile Medical Applications Mobile Medical Applications
- General Data Protection Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data.
- USA HIPAA Health Insurance Portability and Accountability Act
Further, Viedoc4™ is developed in compliance with GAMP5.
Viedoc Logistics is the fully integrated supply management system that is designed to optimize and secure the inventory of your trial. The feature offers a wide range of capabilities with configurable settings designed to provide everything you can expect from a modern RTSM system.
In addition to the EDC system being validated as such, the database set up for the specific study is fully tested and documented by SMERUD according to defined SOPs. The database is designed and specifically adjusted for each particular clinical trial, to create databases that accurately reflect the protocol, facilitate data entry and which have reliable checks implemented to assist with data verification. The database is fully tested by several professionals, including an independent data manager and a statistician, before a final validation step allows the database to go live.