Risk-Based Monitoring & Source Data Review Trial oversight with advanced risk-based monitoring. Let us help you elevate data quality & security.
Risk-Based Monitoring & Source Data Review Trial oversight with advanced risk-based monitoring. Let us help you elevate data quality & security.
Achieve Significant Cost Savings
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.
ACDM Awards Finalist
ACDM Awards 2024 finalist for “Team Excellence in the Management of Clinical Data“
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. We have fully implemented GCP (Good Clinical Practice), FDA guidance on risk-based monitoring, and ISO 14155 standards, ensuring our risk-based monitoring of clinical trials.
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.
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.
Our risk-based monitoring & source data review services reduce the need for SDV. Operational efficiency & cost savings increase without compromising quality or compliance of trial data.
By identifying & prioritizing risks early, our service enables focused resource allocation on critical areas. This ensures better management and mitigation of potential risks in your trial.
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.
Regular central source data reviews maintain a clean database throughout the study, reducing time spent on data cleaning. Our methods decrease time to database lock & 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 & success today.
Get the answers you need about our risk-based monitoring and source data review service
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.
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.
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.
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.
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.
Wondering How It All Works?
Learn more about how we can support your clinical trials.
SPEAK TO AN EXPERT
Beyond protocol development, 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 and saving you time and money. Discover our other services, all focusing on innovation and excellence in clinical research.
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.
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 Appletree 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.