Clinical Trial Services
Data Safety Monitoring Board
HCRI provides DSMB services led by industry thought-leaders and unique to the needs of each trial.
Careful and thorough review of safety data is an important component of clinical trials. You need an unbiased resource that has expertise in your therapeutic area.
HCRI creates, coordinates, and runs Data Safety Monitoring Boards (DSMB). The Institute provides quality DSMB members and provides services that fit the unique needs of your study. The Institute’s academic expertise, impartial stance, and world-wide network of top-tier thought leaders in a wide range of therapeutic areas provides useful insight into the selection of appropriate members for important DSMB responsibilities.
HCRI’s professionals have many years of DSMB experience that aids the operational management of these groups. DSMB services are an important component of almost all clinical trials designed or managed by HCRI. The team’s ability to generate useful reports for use by the DSMB further contributes to our effectiveness.
These reports are usually generated from live data, which has not completed the “cleaning” process. To maintain clinical integrity, HCRI’s process mandates that a non-team member statistician generate the unblinded tables and listings. The DSMB report undergoes independent medical and statistical review before being distributed to the DSMB. The HCRI project team and the sponsor remain blinded to these interim analysis results.
In addition to member selection, other services include:
HCRI creates, coordinates, and runs Data Safety Monitoring Boards (DSMB). The Institute provides quality DSMB members and provides services that fit the unique needs of your study. The Institute’s academic expertise, impartial stance, and world-wide network of top-tier thought leaders in a wide range of therapeutic areas provides useful insight into the selection of appropriate members for important DSMB responsibilities.
HCRI’s professionals have many years of DSMB experience that aids the operational management of these groups. DSMB services are an important component of almost all clinical trials designed or managed by HCRI. The team’s ability to generate useful reports for use by the DSMB further contributes to our effectiveness.
These reports are usually generated from live data, which has not completed the “cleaning” process. To maintain clinical integrity, HCRI’s process mandates that a non-team member statistician generate the unblinded tables and listings. The DSMB report undergoes independent medical and statistical review before being distributed to the DSMB. The HCRI project team and the sponsor remain blinded to these interim analysis results.
In addition to member selection, other services include:
- Direct contracting with DSMB members
- Establishment of conflict of interest statements
- Preparation of DSMB charter
- Facilitation of DSMB meetings and responsibilities
- Preparation of interim analyses, as blinded or unblinded study reports
