FMD K&L supports end-to-end clinical data management activities at every stage, from development of electronic case report forms (eCRFs) through database lock
Our CDM team is comprised of highly experienced data managers and developers who understand the requirements of sponsors, study sites, and statisticians. Excellent planning and proven SOPs enable us to provide high-quality data to our clients while meeting aggressive timelines.
- Good clinical data management practices (GCDMP)
- International Conference on Harmonisation Good Clinical Practices (ICH-GCP)
- 21 CFR Part 11 compliance
- HIPPA requirements
- Applicable regulatory guidelines
Our team has extensive experience handling both paper CRFs and eCRFs, with proficiency in pharmaceuticals, biotechnologies, and medical devices. Project management is a core competency, enabling early problem solving, reduced oversight time, and optimal efficiency.
- Data management plan (DMP) & all related data management (DM) document development
- Database design and development (including eCRF, edit check specification creation & user acceptance testing)
- Data entry
- Data review & query management
- External data transfer & reconciliation
- SAE reconciliation
- Dictionary coding (MedDRA & WHO Drug)
- Database lock
- Study archive
Clients of FMD K&L can expect flexibility in meeting changing data management requirements, seamless implementation into systems and processes, and best practices customized to their programs.
Data management services are available individually or as part of an end-to-end solution.
FMD K&L is certified for multiple EDCs including Rave, Inform, Medrio, OpenClinica and Oracle Clinical RDC.