Data Monitoring Committee

solution-bs

TRiNDS is a specialized contract research organization (CRO) leveraging experience in Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD), Pompe Disease, and other neuromuscular disorders. TRiNDS runs a standing data monitoring committee (DMC) specialized in neuromuscular disorder with active member consulting agreements, standard operating procedures (SOPs), and study-specific charter templates. Established in 2005, our DMC (also referred to as Data and Safety Monitoring Board (DSMB)) has supported a wide range of clinical projects in all study phases, including single ascending and multiple ascending doses (SAD/MAD) to review and approve dose escalations. We support both unblinded and blinded projects with a secondary unblinded biostatistician if needed.

Our current standing DMC is made up of experts in the following areas:

  • Neurology
  • Cardiology
  • Biostatistics
  • Patient advocacy
  • Additional expertise is added on an as needed basis

We offer support for:

Project Planning

  • Protocol review focused on safety and overall design
  • Study specific DMC plan and charter
  • Template meeting reports: blinded and un-blinded

Project Execution

  • Schedule and coordinate DMC meetings
  • Coordinate and prepare DMC meeting reports: blinded and un-blinded
  • Meeting documentation for sponsor and clinical sites