Biometrics Optimization Solution (B.O.S)

Responding to ICH GCP E6(R2) and Oversight Requirements

Starting with a complete biometrics GAP analysis, to determine what steps to take to plan and implement your optimal data oversight strategy, we will work with you to develop a customized approach including processes, system selection and deployment and consistent data strategies.

As your partner, we’ll leverage our indication-specific experience to guide you through the full data management process, including:

Guaranteed ICH E6 (R2) Compliance
Integrated Risk Management Analysis & Mitigation
Improved Control of Data Acquisition, Storage & Reporting
All supported by a complete governance package to prove effective oversight and risk management

Why use B.O.S.?

Oversight is a requirement of the ICH E6(R2) addendum, according to which the ultimate responsibility for the quality and integrity of the trial data resides with the sponsor. This requires a risk-based approach to quality management and oversight. Conducting clinical data oversight can be challenging, particularly for companies that lack functional experts internally.

There are several ways to mitigate risks with an outsourcing model; using an experienced team through B.O.S. is both complete and cost-effective.

Why choose Alira Health?

The CROS NT and Alira Health biometrics team has provided expert statistical guidance for over 500 projects, including regulatory communication and submissions, study-based data management, biostatistics, and statistical programming. You will benefit from our: