Data Management
Factory’s DM team stays on top of the most recent regulatory changes and state of the art technologies that apply to medical device trials. Our Data Managers understand the requirements and needs of a clinical trial and work closely with their team members from clinical, regulatory, medical writing and statistics.
Your data will be well-structured, clean, consistent and in perfect shape to support the claims in your Clinical Study Report. We are committed to deliver within the set timelines: our standard is to accomplish clean database lock within days after Last-Patient-Last-Visit!
CRF Design
As framework for the electronic database, Data Management designs the CRF in close cooperation with the medical writing, clinical and statistics departments to ensure:
Database Setup
Factory CRO partners with different industry-leading database software providers. Together with the Sponsor, we carefully select the platform that offers the most appropriate solution for each specific clinical study and Sponsor needs.
Our standard is to provide our database setup services in either DFdiscover® or iMedNet®. Both systems passed our careful selection with flying colors and, trial after trial, prove to meet the high standards of Factory CRO and those of our clients. The main the features included, but are not limited to:
Please feel free to ask our team for a live demo and/or more information on the elaborate features of these systems [link to contact form].
Data Validation Design / Discrepancy Management
Our Data Managers construct a design of manual and programmed checks, through which we can ensure clean, consistent and unambiguous data.
We adhere to the strategy ‘prevention is better than correction’ by incorporating live feedback mechanisms in our database that actively guide the data completion. Next to that, new and updated data is subject to automated checks at the point of entry and is subject to manual review within one working day. This strategy keeps the sites on board and thereby significantly reduces the query load as well as the costs and efforts that come with it.
Safeguarding the quality of your data is our primary mission!
Data Visualization and Reporting
Stay in control of your study data with our insightful reports and tabulations. Pull up real-time data reports and dashboards directly within the database, receive automated event notifications and/or receive customized reports per request to one of our certified SAS® (Statistical Analysis Software) programmers.
We offer all that is necessary to support insights and signal trends in data that may indicate a need for appropriate action. For example, this may concern safety data trends, safety reporting, eligibility/enrollment issues, data outliers, site performance, CRA performance, CIP or CRF imperfections, etc.
Ask our team about the possibilities for your trial [link to contact form].
Medical Coding
We have certified medical coders in our DM team that can encode your data to the applicable dictionaries (i.e. MedDRA, WHO Drug / WHO-DDE, WHOCC).
Data Integration (API)
Having moved from paper CRF to full EDC studies, the industry continues to look for and develop new technologies that may offer benefits to your clinical trial. In addition to providing our services in paper, hybrid and full EDC studies, Factory CRO is now able to offer the newest data collection innovation: API (Application Programming Interface).
API is a software intermediary that allows two (API-compatible) systems to interact, where they may push or pull certain pieces of data. The latest release of the DFdiscover® software, in use by Factory’s DM team, is equipped with an API module. Realize pulling data (e.g. lab values) directly from an external source (e.g. site EPD) into your database; saving data entry, SDV and data cleaning efforts!
Ask our team about the possibilities for your trial [link to contact form].
Data Lock
With the proper planning and site management, we always ensure that the vast majority of data is in good shape (i.e. locked) as we enter the closing phase of a study. Through this and the close cooperation between our DM and Clinical members of the study team, trial after trial, we manage to achieve clean database lock within days (rather than weeks) after Last-Patient-Last-Visit and almost immediately after the last Monitoring Visit.
“Start sooner, finish faster!”
Data Entry
We provide double data entry for paper-based or hybrid studies. Factory CRO works with a database management system that supports uploading paper CRFs by fax or email. Through the use of a barcode, the system automatically assigns the image to the correct patient and study visit. The database system is equipped with a modality that is called ‘Intelligent Character Recognition (ICR)’, which is a handwriting recognition system that can pre-enter data from the paper image to ensure a high quality of work and to relieve the workload for the Data Entry Operator.
Altogether, this allows very efficient, remote data entry in a manner that safeguards the quality of the data.
Bio-statistical Services
From consultancy on sample size calculation to full statistical analyses, Factory CRO is able to provide the full scale of bio-statistical services through our team of consultants and trusted partners.
CDISC Services
CDISC standards (CDASH, SDTM and ADaM) allow your data to be structured in a way that is globally accepted (i.e. may accelerate regulatory review). Whether you request the conversion of legacy data, or the application of CDISC standards to your study managed at Factory CRO, we are able to meet your needs.
Please be invited to contact our team [link to contact form].