Quality of Clinical Data Report

Enhancing Clinical Due Diligence with Risk-Based Approaches

Data Confidentiality

Ensuring secure exchange of clinical data with a trusted, impartial third-party

Quality of Clinical Data Analysis

Backed by proven RBQM system and top industry SMEs

Rapid Data Analysis

Comprehensive data review across all eClinical systems in just 2 weeks

  • Use Cyntegrity as a partner provider of clinical due diligence​

  • White Label use of Cyntegrity’s clinical due diligence service​

  • Or, subscribe to MyRBQM Portal for templates and internal use

Quality Of Clinical Data

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.

  • This service is exclusively tailored to support M&A or investment activities targeting companies specializing in the development of pharmaceutical products.

Pain Points of Traditional Clinical Due Diligence

Time-consuming analysis

Detailed assessment of big clinical data sets is time-consuming and requires advanced expertise

Confidentiality concerns

Target companies are not keen on sharing their highly sensitive and confidential clinical data

Study performance neglect

Low focus on study performance and management

Urgency constraints

Time-sensitive process

Biased reporting

Biases may lead to missed insights or skewed reporting​

Data trend oversight

Neglecting data trends and oversight of clinical data can lead to suboptimal investment outcomes

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.

Quality of Clinical Data Process Overview

Step 1

Study Data

Step 2

Data Import

Step 3

KRIs Calculation

Step 4

CSM Analysis

Step 5

Quality Of Clinical Data Report

Sources of value added​

  • Data Safety: sharing clinical data only with independent, unbiased 3rd party

  • Comprehensive Insights: Thorough assessment of clinical data quality, compliance, and performance indicators, backed by proven innovative RBQM system and top industry SMEs

  • Synchronized eClinical Data Analysis: Connection to all EDC, CTMS, eCOA, eDiary systems and handling a variety of data formats in one system

  • Customizable Solutions: Tailored analysis to meet specific needs and priorities

  • Streamlined Due Diligence: Accelerates the clinical due diligence process fueled by automation and AI integration

  • Data Security: The platform facilitates submission to a virtual data room (VDR). SOC 2 type 2 and ISO27001 compliant

Executive Summary Example

Clinical Quality Data Report

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.

Potential Findings

Get in touch with Our FSP Experts

Precise deal valuation through enhanced clinical due diligence

  • Study protocol risk assessment & mitigation

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.   

  • RBQM SOPs & Gap Analysis

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

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.