Clinical programs for drug development are highly complex, involving coordination of multiple clinical sites, service laboratories, time constraints and work streams. RBM is a CLIA-certified immunoassay testing laboratory that provides pharmacodynamic protein biomarker services that help solve complex drug development challenges. Along with our innovative biomarker solutions, RBM has experienced Project Managers that provide the required oversight to manage the protein biomarker testing portion of your clinical trial to deliver timely and accurate immunoassay results.
The project management service at RBM will ensure high quality biomarker data is delivered on time in order to meet clinical trial expectations.
A dedicated Project Manager will work on behalf of the client to guide them through the project from start to finish. At each stage of the project, the experienced Project Manager will ensure milestones are met, coordinate any changes during the project, and manage project documents.
Each Project Manager has at least 6 years of experience working at RBM. Unlike the large Central Labs, your dedicated project manager will be with you throughout a multi-year clinical trial.
In support of RBM’s biomarker services, customer data reports are provided in either standard or customized formats to support your needs. All reports are transferred securely through email. Alternative delivery options and data file needs can be modified according to customer requests.
- Standard Data Report
- Included as part of our analysis services.
- Simple list of analyte results for each sample, LDD, LLOQ and analytical range values when available sent as an Excel spreadsheet via secure email.
- Customized Data Report
- Can be made to meet almost any customer specifications for an additional fee.
- Includes specification review and collaboration, system design and programming, test transfer, execution and review of validation process, verification and production transfer(s), and data reconciliation.
RBM has earned CLIA licensure of accreditation from COLA, participates in external proficiency testing programs from CAP, and is capable of supporting Good Laboratory Practice (GLP) studies.