FMD K&L Inc.

FMD K&L Inc.

FMD K&L Inc. is a contract research organization (CRO) offering end-to-end data management, biostatistics, statistical programming and medical writing services as well as CDISC compliant eSubmission services to the pharmaceutical, biotechnology and medical device industries worldwide. Noted for their use of scientific principles, innovative approaches, and streamlined processes optimized for regulatory compliance, K&L takes pride in their ability to provide high quality deliverables on time and within budget. K&L is committed to accuracy, precision and continuous improvement throughout the development life cycle. Their expertise in analyzing and compiling clinical data into a compliant FDA submission is a proven process that has resulted in many faster drug approvals.

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Locations

  • APAC
  • APAC excluding Japan
  • APAC including Japan
  • Asia excluding Japan
  • Asia including Japan
  • Eastern Europe
  • Europe
  • North America
  • Western Europe

Therapeutic Areas

  • Bone / Osteoporosis
  • Cardiovascular
  • CNS
  • Dental and Oral Health
  • Dermatology
  • Diabetes
  • Endocrinology
  • Gastroenterology
  • Genetic Diseases
  • Hematology
  • Hepatology
  • Immunology
  • Infectious Diseases
  • Inflammation
  • Internal Diseases
  • Metabolic Diseases
  • Musculoskeletal
  • Nephrology
  • Neurology
  • Nutrition and Health
  • Obstetrics / Gynecology
  • Oncology
  • Ophthalmology
  • Orthopedics
  • Otolaryngology/ENT (Ear/Nose/Throat)
  • Pediatrics / Neonatology
  • Pharmacology / Toxicology
  • Podiatry
  • Psychiatry
  • Pulmonary
  • Respiratory
  • Rheumatology
  • Sleep
  • Surgery
  • Thrombosis
  • Urology
  • Vaccines

Accreditations

Partners are trained on the functionality of the Coder application, process optimization, and scope of Coder services. This Accreditation teaches Partners to integrate the medical coding solution with EDC studies and administer Coder segments. Coder Accreditation is dependent on the successful completion of the Rave EDC accreditation.
Partners are trained on the functionality of the electronic data capture (EDC) and clinical data management (CDM) system, process optimization exercises and scope of Medidata Rave services. This Accreditation teaches the staff to perform end user training, user and site administration, study build, reporting, outputs and amendment manager.
Partners are trained on the functionality of the RTSM Application, process optimization, best practices using RTSM, and scope of RTSM services. This Accreditation teaches Partners to conduct randomization and clinical trial supply management services (RTSM). RTSM Accreditation is dependent on the successful completion of the Rave EDC Accreditation.