Advancing Data Through Innovation.
Mission Statement:
“At Serious Data, we accelerate clinical research from pre-clinical through clinical development by combining industry expertise, advanced oversight, and cutting-edge technology. Our comprehensive services include expedited data cleaning, precise data entry, regulatory-compliant database management, and expert consultation to support biotech, pharmaceutical companies, and CROs. By integrating AI-driven analytics, predictive modeling, and protocol optimization, we help streamline study execution, ensuring efficiency, accuracy, and compliance at every phase. Our mission is to empower research teams with the tools and insights needed to drive innovation, achieve regulatory success, and ultimately improve patient outcomes.”
About
our company
Driving Clinical Research Forward with Expertise & Innovation
Serious Data is a specialized clinical data management consultancy dedicated to advancing research from pre-clinical through clinical development. We provide end-to-end solutions designed to streamline data workflows, enhance regulatory compliance, and optimize trial efficiency for biotech and pharmaceutical companies.
Our expertise spans:
✅ Expedited data review, cleaning & precise data entry to ensure data integrity.
✅ Comprehensive monitoring & oversight to maintain compliance and trial accuracy.
✅ Timely database lock & submission-ready data to meet critical project deadlines.
✅ Protocol review, case report form (CRF) development & regulatory documentation to support seamless trial execution.
✅ AI-driven analytics & predictive modeling to transform raw data into actionable insights.
With a deep understanding of industry regulations, advanced oversight strategies, and emerging technologies, Serious Data empowers sponsors and CROs to navigate complex trials with confidence—driving efficiency, accuracy, and better patient outcomes.
Our Services
Comprehensive Clinical Resarch & Data Solutions
At Serious Data, we provide end-to-end clinical research support, ensuring accuracy, reliability, and efficiency at every stage of the trial lifecycle. From database build to final database lock, our rigorous data cleaning processes and expert data entry solutions safeguard data integrity while identifying risks and discrepancies critical to delivering high-quality, submission-ready datasets. Our expertise extends beyond traditional data management to include database migrations, protocol review, regulatory documentation, and trial oversight. Through our Clinical Innovation Network, we also connect industry leaders, fostering strategic collaborations that drive research success.
End to End Clinical Trial Optimization
Our team of experts provides comprehensive clinical systems support, ensuring secure, compliant, and efficient data infrastructure tailored to your study’s unique requirements. With extensive experience in electronic data capture (EDC) systems, regulatory compliance, and trial oversight, we optimize workflows to enhance data integrity, streamline operations, and reduce study delays. From database design and validation to ongoing system support and seamless database migrations, we ensure your clinical trial data remains accurate, accessible, and audit-ready throughout the entire study lifecycle.
Comprehensive Centralized Monitoring, Audit and Quality Oversight
Ensure proactive trial oversight, regulatory compliance, and data integrity with Serious Data’s full-service centralized monitoring solutions. Our highly experienced team, with deep expertise in audit, quality assurance (QA), and quality management systems (QMS), provides real-time risk detection, trend analysis, and data-driven insights to enhance trial performance.
With in-house adjudication capabilities, we efficiently manage complex data reviews, ensuring protocol adherence, patient safety, and regulatory compliance. Our team is equipped to handle full-scale centralized monitoring, leveraging advanced analytics and compliance-driven methodologies to detect risks early, optimize trial operations, and support seamless FDA and global regulatory submissions.
💡 Trust our expertise to safeguard your clinical trials with precision, compliance, and efficiency.
Unmatched Expertise - No Strings Attached
At Serious Data, we believe that guidance and collaboration should never come at an extra cost. As part of our core services, every client has a dedicated point of contact, ensuring seamless communication and expert support at every step of their clinical research journey. Behind the scenes, our trusted advisors—with deep expertise in clinical operations, regulatory strategy, and trial oversight—work to provide tailored solutions and proactive insights designed to optimize your study’s success.
We are more than just a vendor; we are a true partner in your research efforts. Whether you need data-driven strategies, regulatory guidance, or trial optimization insights, we are here to help—at no additional cost. Simply reach out through our Inquiry Form, and our team will provide the support and direction you need to move forward with confidence.
💡 At Serious Data, your success is our mission. Let’s collaborate.
Unlock the full potential of your data with cutting-edge analytics and predictive intelligence. Serious Data X transforms raw data into actionable insights, empowering organizations to make strategic, data-driven decisions and optimize clinical research outcomes. Our expertise spans advanced statistical modeling, allowing for deeper insights through powerful data analysis, as well as SAS programming and machine learning, leveraging automation and AI to enhance data processing and interpretation. We specialize in predictive analytics and PK/PD modeling, enabling precise forecasting and pharmacokinetic analysis to optimize drug development. Additionally, we provide comprehensive protocol review and CRF development, ensuring accuracy, compliance, and efficiency in study design. Our team also supports regulatory document creation, streamlining submissions with expertly crafted documentation to facilitate approvals.
💡 Turn complex data into clear, actionable strategies with Serious Data X.
GLP Consulting & Preclinical Expertise
Navigating Good Laboratory Practice (GLP) regulations is critical to ensuring preclinical study integrity, regulatory compliance, and seamless progression to clinical trials. At Serious Data, we provide expert GLP consulting backed by industry-recognized credentials and extensive preclinical experience. Our team offers tailored guidance on study design, compliance frameworks, and data integration strategies, ensuring alignment with global regulatory standards.
From GLP-compliant documentation and quality oversight to data management integration and preclinical operations support, we help organizations streamline processes, mitigate risk, and accelerate their path to clinical development.
💡 Ensure your preclinical research meets the highest regulatory standards—partner with Serious Data for expert GLP consulting.
Let Serious Data Elevate Your Training & Onboarding!
Empower your team with our Comprehensive Clinical Data Management (CDM) Training Guide—designed to streamline onboarding and enhance data management expertise.
💡 Limited-Time Offer: Get it for just $75 (Originally $150)!
✅ Establish a strong foundation in CDM processes, terminology, and best practices.
✅ Ensure regulatory compliance with key industry standards (ICH-GCP, FDA, EMA, CDISC SDTM).
✅ Enhance technical skills in data collection, validation, query management, and database design.
✅ Bridge the gap between theory & practice with real-world examples, case studies, and expert insights.
✅ Accelerate career growth for new and advancing clinical data professionals.
🔹 A $150 Value—Now 50%
Download a free copy of our “Serious Data - Query Best Practices 2025”
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