What We Do

Data Management
FMD K&L’s data management team provides a wide-range of services, including: Data Management Plan (DMP) and all Related Data Management (DM) Document Development Database Development (including eCRF and Edit Check Specification Creation and User Acceptance Testing) Data Entry  Data Review and Query Management External Data Transfer and Reconciliation  SAE Reconciliation ...
Biostatistics
No matter where you are in the process of product development and regulatory approval, FMD K&L has the biostatistical experience and solutions required to help bring your product to market. With an efficient organizational structure designed to promote high quality standards, we have garnered a group of broadly experienced biostatisticians with in‐depth expertise in...
Statistical Programming
FMD K&L’s statistical programming team provides excellent SAS programming services to the biopharmaceutical industry, which include: Development of Study Data Tabulation Model (SDTM) Datasets Development of Analysis Datasets (ADaM) Creation of Tables, Listings, and Figures (TLF), In-text Tables, and Appendices Support of Clinical Study Report (CSR), Integrated Summary of...
eSubmission/CDISC
FMD K&L understands the value of Standardized Study Data as it relates to the Clinical Data Interchange Standards Consortium (CDISC) specifications. We are proud to be a CDISC Registered Solutions Provider and have been involved in CDISC Standards since 2002. Our data management team builds clinical databases using CDASH standards and advanced EDC technology to minimize...
Medical Writing
FMD K&L has experienced medical writers that produce a wide-range of medical and scientific documentation in support of NDAs / sNDAs and EMAs (European Agency Filing). Our writers combine their extensive industry knowledge with their professional writing skills to produce documents that firmly meet the standards imposed by regulatory agencies. Whatever your medical writing...
Drug Safety
Patient safety is a critical component to clinical trials. Monitoring the safety signals throughout the whole drug development process and real life use is a key process to ensure patient safety. FMD K&L’s safety system is based on the industry leading Argus system. We can also establish B2B connection to our sponsor’s safety system and perform the services using our...
At FMD K&L, we understand that Clinical Operations are crucial to your clinical trial success. We have Clinical Operations teams located throughout various regions around the world to support your needs. Our clinical operations department is composed of highly qualified and experienced CRAs, project managers, and a QC team. We can provide clinical study management services...