BIOSTATISTICS SERVICES
Blinding and randomization are critical to a rigorous, well-conducted randomized controlled trial (RCT).
PharPoint’s Auxiliary Services Group can provide laboratory sample blinding and randomization services can be offered as individual services or provided in addition to PharPoint’s full scope of CRO services.
PharPoint’s Auxiliary Services Group is an independent function that sits between biometrics departments to facilitate services that require cross-functional efficiencies. The services this team provides includes external committee formation, management, and training; laboratory sample blinding; and randomization planning.
PharPoint’s randomization and blinding services allow Sponsors to:
Streamline Process Management
PharPoint’s support provides centralized management for clients to support seamless processes across multiple functional areas. This allows study teams to confidently operate with controlled transparency – supporting the facilitation of project communication, documentation, and collaboration.
Optimize Resource Allocation
PharPoint’s Auxiliary Services Group provides clear planning and project management that can help Sponsors reduce unnecessary redundancies between vendors and/or cross-functional teams. For Sponsors looking to minimize their number of in-house unblinded personnel, PharPoint’s independent unblinded team can provide all unblinded services needed.
Build the Team You Need
PharPoint works flexibly and can provide “a la carte” or full-package services to help you meet study goals in a way that best suits your unique needs. Whether you’re keeping biostatistics primarily in-house and just need a little extra support, are using a vendor that doesn’t quite provide all the services you’re looking for, or you’re hoping to find a CRO that can provide soup-to-nuts biostatistics and biostatistics adjacent services, PharPoint can help.
EXPLORE RELATED RESOURCES
Randomization Planning SERVICES INCLUDE:
- Creation of a randomization plan that details randomization process and includes the generation of any randomization or kit lists
- Generation and verification of randomization or kit list per randomization plan by non-study statistician
- Provision of list to study sites or randomization vendor as appropriate
- Receipt of randomization and kit lists electronically or via paper
Laboratory Sample Blinding Services Include:
- Generation of laboratory sample blinding plan (describes blinding level for each sample; process for generation of blinding numbers and packets; process for generating datasets containing results from laboratory testing)
- Generation and verification of laboratory sample blinding numbers for all study participants
- Preparation of sample packets containing printed blinded laboratory slides and test tube labels for sectioning and/or block blinding
- Set up data transfer agreements (DTAs) with all vendors for transfer of data
- Import and unblinding of data following vendor data collection
- Electronic data transfer of unblinded data to Sponsor or designee