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% Off! Or Get It FREE with a Paid Membership to Our Clinical Innovation Network!

Join Serious Data’s Clinical Innovation Network!

"Optimize query management with our FREE Serious Data - Query Best Practices guide! Streamline resolution, enhance data quality, and stay compliant—download now!"

Expand Your Reach. Elevate Your Brand. Accelerate Your Success.

Serious Data’s Clinical Innovation Network is designed to amplify your industry presence, connect you with key decision-makers, and provide strategic support to help your company thrive in the competitive clinical research landscape. Members gain exclusive access to high-impact marketing, targeted networking, and expert consulting, ensuring their brand stands out among industry leaders and much, much more.

Through this platform, companies unlock unparalleled opportunities to forge partnerships, strengthen regulatory strategies, and accelerate clinical development. Membership provides the critical resources needed to navigate the complexities of clinical research while building a strong, recognizable industry presence.

Exclusive Member Benefits:

✅ 1 Complimentary Protocol Review – Ensure study design accuracy and compliance with expert analysis.
✅ Advisory on U.S. Clinical Trial Setup – Gain expert insights on selecting and working with top CROs.
✅ Regulatory & FDA Compliance Guidance – Navigate submission pathways with confidence and efficiency.

💡 Join today and position your company at the forefront of clinical innovation.

As part of your membership, you’ll gain access to our Clinical Data Management (CDM) Onboarding & Training—FREE with a Clinical Innovation Network membership or available for $150 for non-members.

Limited-Time Offer: Non-members can now save 50% and get the full training for just $75 for a short time!

This is the first in a series of expert-led training programs designed to enhance clinical operations, regulatory compliance, and trial oversight.

📥 Plus, download our complimentary Serious Data - Query Best Practices guide for FREE—helping you streamline query management and improve data quality in your trials.

Act now to take advantage of this exclusive opportunity!

  • With over 25 years of experience in clinical data management across multiple therapeutic areas, including oncology trials, I have a proven track record of leading and managing complex clinical research projects from initiation through successful completion.

    • Extensive Expertise: Experienced in overseeing Phase I-III clinical trials, database migrations, EDC setup, data cleaning, and ensuring compliance with ALCOA principles.

    • Project Leadership: Successfully led projects involving database design, CRF creation, data review, and reconciliation, utilizing tools such as Medidata Rave and SAS programming for efficient data handling.

    • Strategic Vendor and Team Management: Demonstrated success in managing vendor relationships for clinical database migrations and patient stratification, developing detailed project timelines, test scripts, and leading cross-functional teams to ensure data accuracy and regulatory compliance.

  • At Serious Data, we are supported by a team of trusted industry advisors who enhance the capabilities of our data management experts. These advisors bring extensive experience and deep expertise in clinical trial monitoring, biostatistics, and advanced data analytics. Their strategic guidance, from developing innovative data management frameworks to applying machine learning and predictive analytics, empowers our team to maintain the highest standards of data integrity and compliance. With their support, we ensure that our clients receive tailored, high-quality solutions, fostering efficiency, reducing risks, and delivering actionable insights that drive success in complex clinical trials.

  • Serious Data LLC is growing its team to include highly skilled Clinical Data Managers and Clinical Research Associates. With expertise in data management, data entry, data cleaning, reporting, and comprehensive monitoring. Our new team members will be strategically located in key markets to support major clinical research hospitals. This expansion reinforces our commitment to delivering outstanding service and adapting to the evolving needs of clinical research. 

Meet the team

Our team combines deep expertise in clinical data management, clinical operations, and advanced analytics with a commitment to delivering accuracy, efficiency, and compliance at every stage of your trial. Meet the professionals dedicated to ensuring your success.

Contact Us

Interested in working together? Fill out some info and we will be in touch shortly. We can’t wait to hear from you!

Interested in investment opportunities?

General Inquiries:

Join The Serious Data Team

Be part of a team shaping the future of clinical data management