Data Management
Clinical Data Management and Database Programming
Clinical data management for present-day biopharmaceutical research encompasses a diverse set of activities. The clinical data manager has expertise in both the clinical and technical elements. He or she is a key contributor and collaborates with functional area experts including the medical monitor, safety specialist, biostatistician, clinical lead, clinical research associates, medical writer, and regulatory and compliance associates; and ensures that the right technologies are used for the study and the specifications and validation are optimal and adhere to regulations. The data manager is the key team member responsible for receipt of data from multiple sources and coding, reconciliation, and validation of the clinical data. PROMETRIKA has the experienced clinical data managers to guide sponsors through the many considerations and steps toward a comprehensive data management plan that supports the sponsor’s clinical plan.
PROMETRIKA provides comprehensive and customizable data management and database programming services to meet the needs of our biopharmaceutical development sponsors. We provide the full complement of data delivery services necessary for accurate and compliant analysis of clinical data. PROMETRIKA has extensive experience in supplying CDISC compliant data transfers.
Our data management team is equally well-versed in the management of electronic data capture (EDC) or paper-based systems. In many trials, EDC can be a time- and cost-saving solution to reaching a final database. However, there are situations in which paper-based data collection, or a hybrid model, is more appropriate and PROMETRIKA has the experience to help sponsors determine what will work best for a particular trial.
Each Data Management staff member is trained in at least one leading industry EDC products (Medidata RAVE®, Oracle Clinical RDC®, Phase Forward Inform®, BioClinical Express®, Data Trak eClinical®) and can easily transition to new solutions. For a full description of our EDC services, please click here.
PROMETRIKA’s clinical data managers have an average of 11 years of experience. We are an Industry Partner with the Society for Clinical Data Managers (SCDM) and most of our Clinical Data Managers are Certified Clinical Data Managers (CCDM). Additionally, our staff includes MSSO MedDRA certified coders.
Based on the sponsor’s needs, PROMETRIKA Data Management can provide complete study coverage, individualized functional services, or customized services. Our services include:
- Data Management Plan (DMP) development
- CRF design and annotation
- Database design, creation, and maintenance (CDISC SDTM compatible)
- EDC design, User Acceptance Testing, administration, and site support
- Call center for registration and randomization
- Data validation programming
- Adverse event, medical history, and medication coding (MedDRA, WHODrug, WHOART, ICD)
- Safety database design and AE/SAE reconciliation
- Legacy database integration and validation
- Database QC audits
- On-site presence at sponsor’s or third-party location
- Remedial services for “at risk” projects
- SOPs and metadata standards development
Data management services can include sponsor access to PROMETRIKA or third-party-vendor hosted EDC systems, secure portal access to view data listings and metrics, sFTP site for data transfer, and CRF image upload to the sponsor’s portal.
International Experience
PROMETRIKA’s experienced team has successfully managed data of subjects in international studies (Canada, Australia, France, Germany, Austria, Spain, the United Kingdom, Russia, India, and South Africa).