In the fast-paced world of pharmaceutical mergers and acquisitions, informed decisions are paramount. To navigate these complexities with confidence, companies require a robust understanding of the clinical landscape they are stepping into. Proudly introducing our unique offering, RBQM-supported Clinical Due Diligence, a pioneering service that enriches the conventional Quality of Earnings report, enhancing the evaluation of potential investments.

At the heart of this innovative approach lies a compelling value proposition. Our offering provides an unbiased, customizable Quality of Clinical Data Report, meticulously crafted to complement the clinical due diligence process. Additionally, what sets us apart is not just the report itself; it’s the technology-supported framework that underpins our service.

Our Quality of Clinical Data Report is designed to offer an in-depth view of the target company’s asset, covering crucial aspects of data quality, reliability, regulatory compliance, and study performance. Our reports leave no stone unturned, from minor details to major insights with potential implications for trial outcomes.

Central to the ICH GCP-compliant methodology is comprehensive CSM analysis within the MyRBQM® Portal, our proprietary cloud solution that enables clinical research organizations to implement AI-augmented Risk-based Quality Management (RBQM) in clinical trials.

The added value of incorporating a Quality of Clinical Data report alongside a Quality of Earnings report in the due diligence process cannot be overstated. Yet, essential challenges remain hidden within this process, posing significant risks to acquirers. Therefore, the pain points in clinical due diligence are not merely inconveniences—they are serious threats to the success and sustainability of pharmaceutical investments. Addressing these challenges requires a concerted effort to streamline processes, enhance data transparency, and foster a culture of diligence and integrity within the industry. Moreover, only by confronting these pain points head-on can stakeholders mitigate risks and unlock the full potential of their M&A investments in the constantly changing field of healthcare innovation.

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In conclusion, integrating a Quality of Clinical Data Report serves as a cornerstone in overcoming the challenges of clinical due diligence in pharmaceutical M&A. By furnishing a reliable, unbiased, and comprehensive clinical data assessment, buyers can confidently make informed decisions. This commitment to data integrity not only enhances the reliability of pharmaceutical investments but also ensures the safety and efficacy of pharmaceutical assets, ultimately advancing the collective goal of improving patient outcomes and driving healthcare innovation.

Holistic risk-based quality management starts with de-risking the protocol before your study goes live. Identification of potential issues that may arise is crucial to effective risk assessment before the study begins. We help you proactively drive quality by designing quality into the study protocol.   

We help your organization implement a system to manage quality throughout all stages of the trial process. Besides providing you with the appropriate templates, we help identify gaps in the existing standard operating procedures and recommend changes based on industry best practices.

Centralized Monitoring within a risk-based framework can alleviate many of the considerable barriers compared to traditional site-based studies. Our team of experienced Central Monitors helps you oversee the conduct of your trial and timely address risks while the study is ongoing.