Biometrics

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:

  • Exceptional customer service and site relations
  • In-depth expertise across the entire clinical trial process
  • Flexible and tailored service delivered by multidisciplinary and global teams
  • Frequent, transparent, and professional communication
  • Guarantee we will lead your study efficiently, safely, and successfully

Related News

Clinical Digital Health MedTech Pharma
News November 16, 2021
Alira Health Further Expands its Digital Healthcare Platform with the Acquisition of Patchai
We acquired Patchai, a digital health technology company headquartered in Italy. Patchai offers intelligent digital health solutions that engage and empower patients in clinical research(...)
Clinical Digital Health MedTech Pharma
News October 28, 2021
Alira Health Acquires BEPATIENT, A Step Forward in Humanizing Healthcare
We acquired BEPATIENT, a European healthcare technology company. BEPATIENT offers ‘real life’ digital patient data capture solutions for large pharmaceutical manufacturers, medical(...)
Clinical
Events October 22, 2021
Event: OCT Nordics 2021
Meet us at OCT Nordics October 26- 27, 2021.
Clinical
Events October 22, 2021
Event: OCT New England
Meet us at Outsourcing in Clinical Trials New England.
Clinical
Publications October 7, 2021
Tips for Successful Sponsor and CRO Collaboration
The relationship between Sponsor and CRO is a critical aspect of an effective and timely clinical trial; when the relationship is transparent and smooth, the benefit is seen by all parties.
Clinical
News June 8, 2021
Alira Health Expands Its Global Clinical and Data Capabilities Through the Acquisition of CROS NT
We have acquired CROS NT, a data-driven Contract Research Organization (CRO) headquartered in Italy with offices across Europe and the United States. CROS NT provides high quality,(...)
Clinical
Multimedia June 4, 2021
Managing Relationships Between CROs and Clinical Trial Sites
Join us in this special episode of Alira Health’s Transformation Talks with a full cast of Alira Health experts.

Our locations around the globe

Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.