In some cases, we're asked to provide services for just one piece of the biometrics component of a clinical trial project or program, such as clinical data management services OR biostatistical services. While in theory this set-up is perfectly acceptable, there are potential benefits that could be realized by having one contract research organization (CRO) support both the clinical data management and biostatistical components for your clinical trial project or program.
When one CRO provides both clinical data management and biostatistics services for a trial, you can benefit in the following ways:
1) Well-designed database and less re-work
Clinical data management and biostatistical experts collaborate from the earliest stages of study start-up. Early collaboration on CRF design, clinical database set-up, and the clinical data validation plan ensures that the clinical data will support your objectives and reduces the potential for costly statistical re-work associated with an unfamiliar or poorly designed database.
2) Cleaner data
Experienced clinical data managers can provide databases with error rates far below industry standards. Focusing on building quality into every clinical database from CRF design through database lock will ensure that data issues, errors, and anomalies are minimized, and any data errors that do occur will be found early in the process. The earlier data errors are found, the less expensive these errors are to fix. When a clinical database has been designed well and the clinical data management process has been executed successfully, the biostatisticians have many fewer data errors and anomalies to investigate and correct, thus saving you time and money.
3) Better traceability of data and potentially faster approval
When clinical data managers and biostatisticians collaborate early in the clinical trial process, they can focus on creating clinical, SDTM, and analysis databases in a manner that amplifies the traceability of data. Planning for the use of CDASH, SDTM, and ADaM standards from the start will increase traceability, facilitate FDA review, and potentially expedite approval timelines.
What benefits have you noticed when one contract research organization supports both the clinical data management and biostatistical services for your clinical trial project or program?