biostatistics and clinical data management

inSeption collaborates with other organizations who not only share in our commitment to quality, but who also exhibit an ability and proven expertise in providing high quality deliverables on time and within budget.

To that end, inSeption has chosen FMD K&L, Inc. as their exclusive partner in offering Data Management, Biostatistics, Statistical Programming, and CDISC compliant eSubmission to the pharmaceutical, biotechnology and medical device industries worldwide.

Noted for their use of scientific principles, innovative approaches, streamlined processes optimized for regulatory compliance, and a dedication to clients’ success, FMD K&L takes pride in their expertise in analyzing and compiling clinical data into a compliant FDA submission.

Overview of Expertise:

  • Adaptive and Traditional Trial Design
  • Protocol Development
  • Statistical Analysis Plan Development
  • EDC Implementation – Medidata RAVE, Oracle OC/RDC and Oracle InForm, OpenClinica
  • Data Management – Data Standardization (CDASH) for Clinical Studies Phase I-IV
  • Biostatistics – Interim Analysis, Data Monitoring Committee (DMC) Support, Top Line Reviews and CSR Support
  • SAS Programming – SDTM/ADaM Datasets, TLFs, and ISS/ISE Support
  • Validated & Compliant e-Submisson Data Package Preparation – SDTM annotated CRF, define.pdf or define.xml
  • Pharmacovigilance Support