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Risk-based Quality Management Services

Outsource Risk-based Quality Management Services

Our risk-based data quality management ensures that your clinical trial data is always reliable. We minimize the risk of data loss and improve the quality of your data starting at $1280/month per FTE

The clinical trial ecosystem is quickly changing and becoming complex than ever. For improved participant safety and data integrity, it demands a centralized risk-based monitoring approach that utilizes superior data monitoring techniques to mitigate all current as well as upcoming risks.

At Outsource2india, we offer comprehensive risk-based quality management (RBQM) services to help sponsors and clinical research organizations (CROs) actively manage and mitigate risks to quality in both decentralized and virtual clinical trials. Our robust and data-driven RBQM framework and processes evaluate all potential risks and ensure optimized decentralized solutions to help you effectively meet all the specified clinical trial safety guidelines for unmatched safety and efficacy.

Risk-based Quality Management Services We Offer

Outsource2india is a premium risk-based quality management service providing company, offering its cutting-edge RBQM services and solutions to a large number of CROs, sponsors, and healthcare organizations across the world. With patient safety and centricity our primary goal, we leverage cutting-edge solutions and a targeted risk based approach to make your virtual clinical trials robust and centrally optimized. While doing so, we continuously monitor and mitigate your trial's most critical risks before they could affect your critical processes. Our systematic and holistic approach not only helps you to reduce onsite visits but also allows you to manage your overall budget without sacrificing the quality of your data.

Our RBQM services include -

  1. Centralized Risk Assessment Monitoring & Documentation

    Centralized Risk Assessment Monitoring & Documentation

    Our centralized risk assessment monitoring and documentation tools allow us to capture all the key risk indicators and sources for complete risk control measurements. We review data and leverage source data verification strategies to track, manage, and mitigate even the most critical risks that may threaten the safety of your patients as well as the success of your projects.

  2. Data Surveillance

    Data Surveillance

    Through a comprehensive centralized statistical assessment, we test your data to detect all possible anomalies and fluctuations. Our expert RBQ managers interrogate all your clinical and key operational data to score out errors and discrepancies that are often overlooked by traditional monitoring techniques. Our well-designed statistical tests can flag all clinical and operational issues, including fraud, sloppiness, and malfunctioning study equipment that may affect the performance of your clinical trial.

  3. On-site Monitoring

    On-site Monitoring

    We perform targeted site data verification and investigation to reduce your on-site visit burden. Our agile technologies scan all critical and non-critical data components, filtering out noise and helping you to prioritize issues that need your immediate attention. Our competent on-site monitoring approach allows you to leverages your resources efficiently, thus ensuring improved efficiency, increased productivity, and superior risk monitoring.

RBQM Process We Follow

Being a leading risk-based quality management company, we at O2I follow a holistic data-driven RBQM process to help you identify and evaluate all potential risks early on, and provide comprehensive insights to ensure complete patient safety, optimal trial performance, and absolute data integrity. Our RBQM process includes -


01. Need Analysis

We meet you to understand your study, clinical research plans, and protocols, as well as determine the level of decentralization your clinical trial might require


02. Formal Risk Analysis

Our experts then leverage our data-driven RBQM processes to evaluate all potential risks and chalk out appropriate risk monitoring strategies that are optimal for your trial. While doing so, our RBQ managers ensure complete patient safety and data integrity


03. Smart Implementation of Technology

We implement our risk monitoring protocols and other smart technology solutions to help you safely and effectively execute your trial, mitigate all potential risks before they turn into a liability, as well as meet all the regulatory requirements


04. Continuous Assessment

Clinical trials need rigorous monitoring and regular, continuous risk assessment. Our risk-based quality management services in India provide you instant insights to quickly and seamlessly accommodate any change in your clinical trial, whether it is patient availability or any sudden shift in the research site or conditions

Other Services You Can Benefit From

Why Outsource Risk-based Quality Management Services to Outsource2india?

Outsource2india is a leading risk-based quality management service provider offering simple, affordable, and easy-to-follow RBQM solutions for effective clinical monitoring. Our robust RBQM framework relies on an industry-leading cloud-based risk-based monitoring platform that helps you to detect and mitigate all potential risks that may hamper the success of your clinical trial. We have a rich industrial experience of helping numerous CROs and life science companies streamline their clinical trial monitoring processes, bringing in better productivity and efficient use of resources, without compromising on the quality of data.

Outsourcing risk-based quality management services to us can help you enjoy the following benefits -

  • Customized Solutions

    Our RBQM solutions can be completely customized as per your clinical trial requirements. Our tailored solutions can help you easily scale our services as per your trial needs.

  • Competitive Prices

    We offer our RBQM services at highly cost-effective rates. Our frameworks ensure the complete safety and efficacy of your clinical trials, without significantly increasing your budget.

  • Instant Access to Certified RBQ Managers

    We work with some of the best talents in the industry. With complete knowledge of the quality risk management processes, they can help you quickly and easily implement decentralization solutions across your clinical trials as well as actively manage and mitigate all potential risks to quality.

  • Robust Technologies

    We leverage the latest tools and technologies to identify, evaluate and control risks that may otherwise hamper the performance of your clinical trial. Our real-time risk management approaches boost both your participants' safety as well as the likelihood of the success of the trial.

  • Dedicated Project Managers

    Our dedicated project manager acts as your single point of contact. With the complete information about your project, he can guide you with all aspects of QRM, right from planning to execution.

  • Strict Adherence to Project Timelines

    From risk identification to its mitigation, our experts do everything quickly and efficiently, without hampering the timelines of your project.

  • 24/7 Help and Support

    With us, you never have to worry about working under stringent business hours anymore. Our customer service executives are available round the clock, 365 days a year for quick and timely resolution of all your queries and concerns.

  • Complete Peace of Mind

    Our risk based quality management in clinical trials covers everything, right from risk identification to evaluation to mitigation, review, and documentation, allowing you to improve the operational success of your clinical trial while ensuring complete peace of mind.

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Hello, I wanted to reach out to you directly and express my gratitude for the hard work that the Data team, as well as the AR team, has done with EJ practice. I have pushed both teams extremely hard over the past month and their efforts, as well as ours, have paid off.

RCM Account Manager, EMR System Provider, FL, USA More Testimonials »

Outsource Risk-based Quality Management Services to Outsource2india

Want to access, analyze, and mitigate risks while conducting clinical trials? Outsource risk-based quality management services to Outsource2india and identify the right risk assessment requirements of your clinical trials. Our focused, fast-paced, and cost-effective healthcare services help you leap your traditional and time-consuming styles of conducting clinical trials to modern, centralized clinical trial platforms while ensuring continuous patient monitoring and seamless collection of data that's free of all errors and patient safety risks.

Simply contact us and let us know your RBQM service requirements and we'll get back to you with a customized clinical trial monitoring plan that ensures complete patient safety and data quality throughout your trial.

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