TRiNDS is a specialized contract research organization (CRO) leveraging experience in Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD), Myotonic Dystrophy (DM1), Pompe Disease, and other neuromuscular disorders. Under the direction of TRiNDS Strategic Solutions, the TRiNDS data monitoring committee (DMC) is focused on neuromuscular disorders with a variety of members with standing consulting agreements. 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
  • Nephrology
  • Urology
  • 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

Contact us today to learn how TRiNDS can support your development goals.