TRIAL OVERSIGHT WITH ADVANCED RISK-BASED MONITORING

Elevate Data Quality and Security

NIncreased data quality
NCost effective and compliant processes
NProactive risk detection
NReal-time analyses

Trial Oversight with Advanced Risk-Based Monitoring

Elevate Data Quality and Security

NIncreased data quality
NCost effective and compliant processes
NProactive risk detection
NReal-time analyses

Achieve significant cost savings with our risk-based monitoring and source data review

Our risk-based monitoring and source data review services are dedicated to ensuring the highest quality, accuracy, validity, and reliability of your clinical trial data. Utilizing state-of-the-art technology and an expert multidisciplinary team, we oversee data quality control and comprehensive data monitoring in ways that looking SDV simply cannot.

Discover how our services play a crucial role in data quality and risk management.

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Main areas of risk-based monitoring and source data review

Unleash the potential of our service offerings

Our service refers to the innovative approach of remotely overseeing and analyzing trial data and study activities. This method is designed to ensure the quality and integrity of study data, while also verifying adherence to study protocols, eCRF completion guidelines, training materials, and regulatory requirements. Our service complements and streamlines traditional on-site monitoring methods, with the objective of enhancing efficiency, reducing queries, and supporting risk based-monitoring approaches. Wemedoo can enhance the role of site and medical monitors while supporting them in providing more streamlined and higher quality services. This will lead to more effective and compliant clinical trial processes.

Risk-based clinical data management

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Our services follow a risk-based clinical data management approach. The approach begins with the study protocol. Our expert data managers review and analyze the protocol for potential risks with the study design and schedule of assessments. We also define trial-critical data which to include in our data validation plan for review during study conduct.

Source data review and cleaning

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Timely and targeted data review cycles, or complete ones, are essential for maintaining data quality and for identifying data entry issues before they escalate. We incorporate well-timed manual review cycles to identify issues as soon as possible during trial conduct, reducing costs and streamlining resource allocation.

Audit Trail Review (ATR)

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Our team of clinical data managers, scientists, and biostatisticians can set up and perform ATRs in most any fashion. With our oomnia unified clinical research software, all data and metadata is instantly available for our real-time integrated graphical reports. Our team can help you define, implement, and execute an ATR strategy for one, or a series of clinical trials.

CTMS integration for real-time feedback

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Our risk-based monitoring and source data review services enable immediate responses to identified issues or deviations, fostering an environment of continuous improvement and real-time problem resolution in the study process. All aspects of the central monitoring services can be custom integrated with our CTMS for simple trial management.

Data validation plan

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We formulate a comprehensive data validation plan, clearly outlining data review sequences and strategies. This includes an adaptive risk-based approach for timing of review cycles, the prioritization of critical data points, as well as the use of statistical data models.

Statistical data monitoring

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We use statistical data modelling in real time to identify unusual data patterns or deviations from expected results. This approach enables effective resource allocation towards areas with higher risk, enhancing overall study efficacy. This is essential to proactively detecting patterns not visible by traditional manual data review methods.

Custom real-time statistical data analytics and reporting

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Our clinical data science specialists are experts in creating custom real-time analytical integrated graphical reports to detect quality risks. As our oomnia clinical trial software has a unified database, we can create risk analytics tools including key risk indicators (KRIs) and quality tolerance limits (QTLs) to proactively identify trends resulting from known or predicted risks.

Risk-based clinical data management

:

;

Our services follow a risk-based clinical data management approach. The approach begins with the study protocol. Our expert data managers review and analyze the protocol for potential risks with the study design and schedule of assessments. We also define trial-critical data which to include in our data validation plan for review during study conduct.

Source data review and cleaning

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;

Well-timed targeted, or complete, data review cycles are critical to data quality, and to identify data entry issues before they become widespread. We incorporate well-timed manual review cycles to identify issues as soon as possible during trial conduct, reducing costs and streamlining resource allocation.

Audit Trail Review (ATR)

:

;

Our team of clinical data managers, scientists, and biostatisticians can set up and perform ATRs in most any fashion. With our oomnia unified clinical research software, all data and metadata is instantly available for our real-time integrated graphical reports. Our team can help you define, implement, and execute an ATR strategy for one, or a series of clinical trials.

CTMS integration for real-time feedback

:

;

Our risk-based monitoring and source data review services enable immediate responses to identified issues or deviations, fostering an environment of continuous improvement and real-time problem resolution in the study process. All aspects of the central monitoring services can be custom integrated with our CTMS for simple trial management.

Data validation plan

:

;

We formulate a comprehensive data validation plan, clearly outlining data review sequences and strategies. This includes an adaptive risk-based approach for timing of review cycles, the prioritization of critical data points, as well as the use of statistical data models.

Statistical data monitoring

:

;

We use statistical data modelling in real time to identify unusual data patterns or deviations from expected results. This approach enables effective resource allocation towards areas with higher risk, enhancing overall study efficacy. This is essential proactively detecting patterns not visible by traditional manual data review methods.

Custom real-time statistical data analytics and reporting

:

;

Our clinical data science specialists are experts in creating custom real-time analytical integrated graphical reports to detect quality risks. As our oomnia clinical trial software has a unified database, we can create risk analytics tools including key risk indicators (KRIs) and quality tolerance limits (QTLs) to proactively identify trends resulting from known or predicted risks.

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Benefits of our service

Reap the rewards of enhanced data oversight

Most data quality issues are not detectable using SDV. Using the Wemedoo risk-based monitoring and source data review services significantly increases efficiency. Therefore, costs are reduced by actually resolving data issues not detectable by SDV. This lowers operational costs, maintaining a high quality database without compromising on essential checks. It also results in significantly faster database lock times, as most all issues are proactively resolved far prior to the last site monitoring visits.

Operational Efficiency

Our risk-based monitoring and source data review services reduce the need for SDV. This leads to increased operational efficiency and cost savings without compromising the quality or compliance of your trial data.

Risk-Based Monitoring

By identifying and prioritizing risks early, our service enables focused resource allocation on critical areas. This ensures better management and mitigation of potential risks in your trial.

Real-Time Data Analysis

With the capability to provide immediate feedback and actionable insights based on real-time data analysis, our service facilitates continuous improvement and adaptability in your trial processes.

Faster Database Lock

Regular central source data reviews maintain a clean database throughout the study, reducing the time spent on data cleaning. Our methods decrease the time to database lock and delivery for analysis by 2-3 times.

Eager to explore tailored services?

Discover how our clinical trial services can revolutionize your research. Take the first step towards unmatched trial efficiency and success today.

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Frequently asked questions

Get the answers you need about our risk-based monitoring and source data review service

What key functions does Wemedoo risk-based monitoring and source data review service include?

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Our service encompasses comprehensive risk-based monitoring, source data review and cleaning, statistical data monitoring and modelling, audit trail review, real-time analytics and reporting, and custom CTMS integration. We ensure compliance with protocols and regulations, promote participant safety, while providing real-time feedback for continuous improvement.

How does Wemedoo risk-based monitoring and source data review service enhance data quality?

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We utilize advanced statistical methods and data analysis techniques to identify and address any discrepancies, inconsistencies, or anomalies in study data. By doing so, we ensure the highest standards of data quality and integrity.

What are the efficiency benefits of using our service?

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By reducing the need for SDV we truly increase data quality by us focusing on issues that SDV cannot necessarily identify. Our service significantly increases operational efficiency and reduces associated costs, while increasing data quality or compliance.

How does Wemedoo service support regulatory compliance and audit readiness?

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Our service ensures that your organization and trials are ICH GCP E6(R3) compliant, and that your studies adhere to all protocol and regulatory requirements.

How does our service contribute to participant safety in clinical trials?

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Our risk-based monitoring and source data review service includes safety data monitoring to identify potential safety issues early, enabling prompt intervention to ensure patient safety throughout the trial.

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Learn more about how we can support your cinical trials.

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Explore related services

Discover comprehensive solutions for your clinical trial needs

Beyond risk-based monitoring and source data review, Wemedoo offers a comprehensive suite of integrated data operations services for clinical trials. At each step we ensure your trial meets the highest quality and regulatory standards, while streamlining your clinical trial processes, saving you time and money. Discover our other services, all focusing on innovation and excellence in clinical research.

Protocol Development

Clinical Data Management

eTMF Setup and Administration

Biostatistics and Statistical Programming

CDISC-Compliant Dataset Generation

Medical Writing and Documentation

Proud to be a member of cdisc

Since November 2020, we have been a part of the Clinical Data Interchange Standards Consortium. It is our concern to improve the quality and efficiency of clinical research.

What our clients say

Read more about the experiences from those who have partnered with us

"All jobs, both large and small, are performed with the same dedication to quality, detail, innovative thinking, and rigor. It is always a pleasure to work with the Wemedoo team."

Georg Mathis, PhD

CEO Appeltree CI Group AG

"Wemedoo embodies all the traits desired in a partner in the clinical trial industry – expertise, innovation, reliability, compliance, and attention to detail."

Martina Diminic Smetisko, DMD

Managing Director at Marti Farm Ltd

"Their dedication to, and support of, our projects has resulted in clear quality deliverables. They are always there to answer any questions with expertise in a timely manner. I am looking forward to our next project together."

Volodymyr Stus, MD

Biopharmaceutics and Clinical Research Department Manager at Polpharma SA

Considering unified clinical trial software?

Experience oomnia, our all-in-one clinical trial software which unifies tools, such as EDC, eSource, RTSM, eTMF, ePRO, eCOA, eConsent, and CTMS. In combination with our professional services we can provide end-to-end support to transform your clinical research.

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